Neuromodulatory therapy methods, systems, and devices

Abstract

This disclosure provides a method, apparatus, and system for providing neuromodulatory therapy. The user is instructed to perform a series of movements, including the movement of a target musculoskeletal joint. The user is then provided with a display of a target force level and instructed to match the target force level during the performance of the movements. The movements are repetitive motions involving the movement of a target joint. The target force level in the movement of the target joint is represented by a sinusoidal curve. In some movements, at least a portion of the curve (target force level) displayed to the user is occluded (i.e., not displayed). Therefore, the user needs to estimate the amount of force required to achieve the occluded target force level. The actual force is measured, compared to the target, and feedback is provided to the user regarding the deviation between the target and the actual force. The amount and complexity of the occluding of the curve over a series of sessions may be increased over time.

Description

Technical Field

[0001] (Related Application) This application claims priority based on Australian Provisional Patent Application No. 2023901520, entitled "Methods, Systems, and Devices for Providing Neuromodulation Therapy", filed on May 17, 2023. The entire disclosure of the above application is incorporated herein by reference.

[0002] (Technical Field) The present disclosure relates to rehabilitation systems after musculoskeletal injuries and / or surgical interventions. In certain embodiments, the present disclosure relates to methods, systems, and devices for evaluating the neuromusculoskeletal control of one or more joints, and subsequent application to a rehabilitation program for improving neuromuscular control after musculoskeletal injuries and / or surgical interventions.

Background Art

[0003] Due to various factors such as aging and traumatic injuries, the function of musculoskeletal joints often deteriorates. Therefore, surgical interventions and / or rehabilitation programs are often implemented to restore the function of the affected musculoskeletal joints.

[0004] The control of musculoskeletal joints typically involves multi-system coordination between the nervous and musculoskeletal systems. The nervous system provides both control and sensing / feedback (often using specialized cells) to musculoskeletal components such as muscles, tendons, ligaments, and joints. Damage, surgery, lesions, injuries, or neuromuscular diseases of muscles, joints, ligaments, or tendons usually result in dysfunction or impairment, including specific timing and coordination of motor skills, which can lead to loss of control of musculoskeletal joints and consequently affect daily activities. Joint control, or any muscular control, is often simplified into command messages transmitted from the brain through the central and peripheral nervous systems to the muscles, but in reality, it is a complex process. This is only part of the big picture. For example, consider the action of picking up an egg. A complex feedback process takes place to grasp the egg with just the right amount of force to generate the frictional force needed to lift the egg without crushing it. Command signals are sent from the brain to the muscles of the hand, and the fingers apply pressure to the egg. Sensory receptors in the skin detect the mechanical pressure applied by the muscles and send feedback to the brain as action potential signals. Based on learned experience, the brain controls muscle contraction through an unconscious closed-loop process, applying the appropriate pressure to the egg.

[0005] This action is a precisely tuned closed-loop process in which the command system is constantly adjusted by the feedback system. Within the command system of the central nervous system, there is a balance between excitability and inhibition that strongly influences cortical drive and controls the desired level of motor output. This ensures that a particular action is performed optimally every time. If there is an error in the feedback adjustment system, you might hold the egg too lightly and it slips from your fingers, or you might grip it too tightly and break it. This example shows that both the command system and the feedback adjustment system must function correctly in order to perform voluntary and smooth coordinated movements.

[0006] Therefore, the smoothness of human movement can be considered an indicator of a healthy nervous system. Conversely, awkwardness of movement due to poor control can be considered an indicator of a poorly functioning nervous system. Injuries (but not limited to, injuries to ligaments, cartilage, muscles, tendons, and bones; degenerative diseases such as osteoarthritis; Parkinson's disease; stroke; and mild cognitive impairment) and surgical interventions have been shown to increase awkwardness of movement and prolong the time it takes to complete standard movement tasks. Throughout this disclosure, it should be understood that injury and surgical interventions are mutually interchangeable. Smoothness of movement can be measured from the perspective of neuromuscular control. Neuromuscular control can be defined as applying the appropriate force to the appropriate movement at the appropriate time.

[0007] Loss of control affects both gross and fine motor skills. Loss of gross motor control (e.g., limping) has a serious impact on daily life. On the other hand, loss of fine motor control is often unnoticed in daily life, but it becomes a barrier that prevents athletes striving for high performance from reaching the pinnacle of elite level, keeping them at the level of mediocre athletes.

[0008] At the highest levels of human capability, even slight loss of control can significantly impact the performance of highly skilled activities where accuracy of directed targets is crucial. A slight loss of control can lead to undesirable variability and errors in motor skill execution, resulting in undesirable outcomes. This is particularly important when a slight loss of control in one joint directly affects subsequent joints, creating a chain reaction of negative effects. In such situations, humans attempt to correct or rectify these negative effects to achieve directed target tasks, such as those involving accuracy. This occurs in a constantly changing, dynamic environment where timing and coordination are critical variables. When the body is a multi-plane system of interconnected joints, the negative effects can be dramatic. The impact of slight loss of control is easily understood through the example of a beginner golfer who mishits the ball due to a loss of control in a lower body joint, attempts to correct the swing with their arms, and ends up hitting the ground, instantly experiencing pain in that area due to the sudden impact.

[0009] Currently, there are no reliable methods to quantify neuromuscular control or to identify which joints are affected. Therefore, clinicians typically assess the severity of control loss in musculoskeletal joints and components through subjective examination. Such examinations often involve visually observing the patient performing movement tasks, paying attention to joints, limbs, or body parts from a broad perspective. For example, clinicians often visually observe the degree of lateral deviation of the knee joint during balance exercises to grade the control loss as mild, moderate, or severe. Clinicians then develop or evaluate rehabilitation programs based on this subjective information. However, such subjective, general information lacks the accuracy and measurability to effectively grasp control loss or determine whether rehabilitation interventions are actually effective. As a result, most rehabilitation programs, including postoperative rehabilitation programs, focus on strengthening the musculoskeletal components around the site of injury. This problem is widespread and, due to a lack of progress, leads to patient dissatisfaction. Furthermore, the outdated assessment methods and the resulting economic costs associated with conventional rehabilitation management necessitate advancements in achieving more effective outcomes.

[0010] Traditionally, maximal muscle strength has been used as an indicator of the ability to perform function in measuring neuromuscular disorders. Muscle weakness has traditionally been used as a primary indicator of a lack of recovery when compared to the healthy opposite limb or standardized data. Therefore, many rehabilitation programs focus on strengthening the musculoskeletal components around the injury site, and a typical treatment plan centers on muscle training and quantifying the muscle strength of the injured (or replaced) joint compared to the corresponding healthy opposite joint. For example, a typical rehabilitation program for total knee arthroplasty (TKA) is as follows: Days 1-14: Post-exercise cooling therapy; circumferential compression bandage from ankle to thigh; elevation of affected limb to reduce swelling. Range of motion / muscle strengthening exercises: Quadriceps and gluteal muscle sets; lower limb extension and elevation in supine position; knee extension in supine position (using a roller); knee extension in seated position; passive knee extension in supine position using a heel roller; heel slides in seated and supine positions. Weeks 3-6: Range of motion / strengthening exercises: Isometric contractions of the quadriceps, hamstrings, glutes, and adductor muscles; trunk stabilization exercises; active and assisted range of motion exercises; heel raises, calf stretches, mini squats, and hamstring curls while standing with support; hydrotherapy. Weeks 7-12: Range of Motion / Strengthening Exercises: Core stabilization exercises; squats and single-leg mini-squats; resistance exercises for the quadriceps, hamstrings, glutes, and adductor muscles; active and assisted range of motion exercises.

[0011] As described above, typical programs primarily focus on strengthening the quadriceps, hamstrings, and gluteus maximus, with trunk strengthening exercises only being included formally and without quantitative assessment of progress. Improvement in muscle strength alone does not improve control ability, nor is there any need or attempt to measure or quantify joint control. When patients recovering from knee injuries or total knee arthroplasty (TKA) attempt small, smooth, and controlled movements against resistance (even patients in the final stages of TKA rehabilitation), the movements are often awkward rather than the desired smoothness. Simply increasing maximum muscle strength does not improve the fine control needed for activities such as climbing stairs or pressing the accelerator pedal of a car. Therefore, despite the best efforts of surgeons, physical therapists, and other clinicians, many patients remain dissatisfied with their new knee joints. From a functional standpoint, patients often complain of knee instability during everyday activities such as climbing stairs. A 2022 study by Marsh et al. ("Marsh et al. Health care costs after total knee arthroplasty for satisfied and dissatisfied patients Can J Surg 2022 65(5): E562-E566") reported that more than 36% of patients were dissatisfied with the function of their total knee arthroplasty. Furthermore, these dissatisfied patients incurred an average additional cost of more than $5,483 after total knee arthroplasty, on top of the average cost of $13,523 for satisfied patients.

[0012] Instability during flexion is often underestimated and has not received sufficient attention in rehabilitation, which continues to focus on muscle strengthening. Generally, patients report that knee joint instability is most pronounced at the midpoint of flexion. Climbing stairs is a typical functional movement in which patients report knee joint instability, and this movement tests the ability to control weight-bearing at the midpoint of flexion. In some cases, the unstable knee joint dislocates, followed by a fracture, in which case more complex revision surgery is required. Knee joint instability at the midpoint of flexion has attracted considerable attention from surgeons regarding the best management methods through surgical techniques and implant selection. In particular, there have been significant advances in the design of knee joint implants, and it is now possible to reproduce a knee joint as natural as possible. However, despite these advances, knee joint instability reported by patients remains common, and instability after total knee arthroplasty is a cause of revision surgery. Furthermore, patients experience an average 60% decrease in quadriceps muscle strength after surgery, and 50% of patients show quadriceps atrophy one year after surgery. Further complicating recovery and rehabilitation is the fact that patients undergoing total knee arthroplasty often have advanced, severe osteoarthritis, resulting in years of impaired function in the damaged knee joint. Because the joint cavity of the damaged knee is narrowed and deformed, the adjacent supporting ligaments are loosened, providing little structural support. Furthermore, the damaged knee joint is painful, often swollen, and exacerbates already altered biomechanics, resulting in a generally painful gait. This poor initial condition presents further challenges for rehabilitation.

[0013] Therefore, current approaches that focus on restoring maximum muscle strength do not yield the desired recovery, especially in such patients. Even if muscle strength in the patient's injured area fully recovers, re-injury frequently occurs in or around the original injury site, indicating that complete recovery has not been achieved. Such subsequent injuries to body parts adjacent to or related to the original injury site suggest that insufficient recovery of the original injury site may have affected other connecting parts of the body. This phenomenon is often observed, especially in professional and highly skilled athletes, who return to competition after the initial injury, but experience recurrence or new injuries in related areas due to incomplete recovery of the initial injury. Knee joint injuries are particularly prone to recurrence.

[0014] Similar problems are observed in recovery from anterior cruciate ligament (ACL) tears. The ACL is one of the four main ligaments of the knee, connecting the femur and tibia and functioning as a stabilizing structure that prevents excessive forward movement of the tibia relative to the femur. The ACL is often injured in sports in which a valgus moment occurs in the knee joint when the knee is in a slightly flexed position with the foot on the ground. Under overload conditions, the hamstring muscles may not be able to prevent forward movement of the tibia, and a sudden ACL tear can occur. ACL tears cause knee joint instability, which can lead to joint laxity and functional instability. Furthermore, ACL injuries rarely occur in isolation and may be accompanied by damage to other joint structures such as the meniscus, other ligaments, articular cartilage, bone, and joint capsule, resulting in pain and swelling.

[0015] Musculoskeletal injuries, such as ACL injuries, are often treated by clinicians as injuries that only affect the musculoskeletal system. One surgical treatment is ACL reconstruction, which involves surgically implanting an autologous tendon graft to restore mechanical stability, followed by therapeutic rehabilitation to strengthen the muscles around the knee joint and restore the natural ACL function that existed before the injury. Conventional rehabilitation programs usually include strength training exercises, which generally include resistance training. Despite such invasive and time-consuming interventions, a decline in clinically important indicators such as quadriceps strength and patient-reported function, as well as changes in mechanical load at the knee joint, can persist for many years after surgery, if not permanently. It should also be noted that biomechanical adaptations are widely observed after surgical intervention, leading to changes or abnormalities in the joint load patterns of the knee joint and adjacent joints (sometimes extending to the contralateral side). For example, surgery alone can create a new set of problems in an already damaged knee joint. Such complications include, but are not limited to, damage to the skin, joint capsule, tendon harvest site, blood vessels, or nerves; drilling into the bone; and debridement or removal of tissue associated with early or subsequent maladaptive injury. Furthermore, accurately positioning autologous tendon grafts to completely replicate the natural ACL function pre-injury is extremely difficult, resulting in a permanently different joint morphology from the pre-injury state, further complicating rehabilitation challenges. Over time, such abnormal joint loading can lead to early osteoarthritis within 10-15 years after injury or surgery, limiting daily activities and impairing quality of life. Moreover, despite the many challenges facing ACL rehabilitation, there are no standardized rehabilitation protocols or standard objective tests to indicate rehabilitation recovery or progress. Traditional rehabilitation programs typically include exercises for muscle strengthening, which generally include resistance training. However, muscle strengthening is insufficient as an indicator of rehabilitation progress.This is a problem common to all joint injuries, and despite extensive efforts, surgical interventions and rehabilitation programs often fail to fully restore musculoskeletal joint function. ACL reconstruction surgery is not only an invasive option, but also a costly intervention requiring athletes to undergo long-term rehabilitation of up to 12 months before they can return to competition. Moreover, it does not guarantee or even fully restore the joint. In a recent, unpublished study conducted by the inventors, professional athletes with ACL injuries, even after completing all post-operative rehabilitation and returning to competition professionally, found that voluntary quadriceps strength remained at only 87% of that on the uninjured side. This was despite a rigorous rehabilitation program and extensive strength training with a highly motivated patient group. This result indicates that even with world-class rehabilitation, professional athletes cannot reach an acceptable level of recovery (defined as 95% or higher). Despite decades of research and effort by those involved, a significant gap remains in rehabilitation.

[0016] In addition to physical damage to various structures within a joint caused by injury or surgery, problems such as arthrogenic muscle inhibition (AMI) can occur in tissues that are not inherently damaged, such as muscles. AMI is a persistent neurological depression in undamaged muscle tissue following joint swelling, injury, other forms of injury, or surgical intervention. For example, quadriceps muscle strength often decreases from pre-injury baseline after ACL injury and after immediate inflammation subsides, and this weakness can persist for many years, if not permanent, after surgery. Similarly, hamstring weakness is also common even without direct physical trauma. Less commonly, post-injury weakness of the quadriceps and hamstrings can appear in the contralateral limb, suggesting that a decrease in cortical drive mediated by the central nervous system may be involved in the overall decrease in muscle strength from baseline. Arthropogenic muscle inhibition exhibits control through a balance of excitatory and inhibitory forces, and is considered a natural mechanism designed to protect injured joints through normal regulation within the central nervous system (CNS) that manages cortical drive and motor output. However, arthrogenic muscle inhibition (AMI) can cause maladaptive responses that persist for a long time even after physical injury has healed. Voluntary muscle activity is significantly reduced by co-contraction of antagonistic muscles around the joint, resulting in dynamic joint rigidity and impaired fine motor control. It also significantly limits the progress of rehabilitation and hinders recovery. Increased GABAergic inhibitory interneuron activity leads to the release of the neurotransmitter gamma-aminobutyric acid (GABA), which overmodulates the excitatory system and inhibits the firing of action potentials. As a result, motor output to the muscles decreases, leading to the muscle weakness and atrophy commonly seen in AMI.

[0017] In a knee joint fluid accumulation model, quadriceps inhibition has been shown to occur without pain. It has also been reported that quadriceps inhibition occurs even after the injection of just 10 mL of saline solution. Furthermore, a linear relationship has been shown between inhibition by saline injection and joint pressure. Clearly, some mechanism exists to inhibit movement and protect the joint, regardless of the presence or absence of pain.

[0018] Injuries and subsequent surgeries can lead to a variety of problems, including potential structural deterioration and lesions of surrounding tissues, but not all problems are purely mechanical. Blocking afferent pathways of nerve cells involves the disruption and destruction of ascending and descending pathways between the spinal cord and the brain. Interestingly, animal studies have shown that severance of the ACL equivalent leads to unexpected hyperexcitability in the nerves of the joint and surrounding muscles. Even after ACL reconstruction in these animals, the electrical activity of the nerves does not return to normal. This suggests that the ACL itself plays some unknown role in the fundamental activity of the joint's nervous system. A protective state occurs when healthy sensory input is blocked, but the mechanism behind this is not elucidated by conventional techniques. Furthermore, this highlights that mechanical repair of the joint by surgery is not a complete and final solution. The impact of the anterior cruciate ligament on proper function has been supported by functional magnetic resonance imaging (fMRI) studies, which have shown differences between patients with ACL reconstruction and normal controls. Most importantly, in patients undergoing ACL reconstruction, activity in the frontal lobe, visual cortex, somatosensory cortex, and cerebellum increases despite a decrease in motor output from the cortex to the target site. This mechanism stems from afferent pathway blockade or joint pain or swelling, which alter afferent information. This leads to sensory processing impairment and changes in the somatosensory cortex. After knee joint surgery, a reduction in the representation area of ​​the knee in the somatosensory cortex has been observed, indicating a decrease in sensory input from the adaptively remapped knee. Anterior shift of knee representation on the homunculus has also been reported, suggesting the possibility of new adaptive motor skills developing. The central nervous system is in a fluid state in its plastic response to injury and surgery. Increased reliance on cortical regions increases the resources allocated to neurocognition, motor planning, motor inhibition, and visual processing compared to a healthy knee joint. This increases cognitive load and decreases descending motor output. Corticospinal excitability and motor cortex activation decrease, and intracortical inhibition increases.

[0019] All of these maladjustments can be summarized as arthrogenic muscle inhibition (AMI), leading to reduced fine and even gross motor control reported by patients with joint trauma. At the neurological level, decreased excitability was observed. Specifically, changes in afferent signals from the injured joint caused neuronal inhibition, resulting in a reduction in the motor neuron pool innervating the muscles around the joint, thus confirming that a neurological mechanism contributes to AMI. Simultaneously with this decrease in motor output, clinically observed decreases in electromyographic activity, central activation rate, and muscle force output were observed. Taken together, these findings demonstrate that the decrease in motor output due to joint injury has far-reaching effects, altering the biomechanics of the joint in functional tasks, including fine motor control.

[0020] While afferent input can influence reflex motor activity at the spinal cord level, afferent sensory neurons originating from joint mechanoreceptors, proprioceptors, and nociceptors also ascend the spinal cord. These neurons ultimately form synapses in the thalamus or somatosensory cortex of the brain, where their neurological signals are processed by the central nervous system and have the ability to influence behavior and efferent motor output. Thus, elucidating brain activity in response to joint injury continues to provide important insights into how changes in afferent signals from injured joints affect somatosensory function. Studies using electroencephalography have confirmed the absence of somatosensory evoked potentials after joint injuries such as anterior cruciate ligament rupture, suggesting a loss of neurological transmission between the ligament and the somatosensory cortex, likely due to afferent blockade. Although reinnervation to the somatosensory cortex and new mechanoreceptor connections may occur after injury, these new connections have been shown to be significantly impaired and not produce the same level of neuronal transmission as before the injury.

[0021] Interestingly, disuse of muscle groups has been shown to adversely affect the nervous system in many ways, similar to arthrogenic muscle inhibition (AMI) described herein, leading to decreased muscle activity. In both cases, reduction of motor cortical areas, increased intracortical inhibition, and increased spinal reflex excitability are observed. These factors combine to result in decreased muscle strength, muscle mass, timing, and coactivation of antagonistic muscle pairs. For example, changes in gait associated with quadriceps / hamstring coactivation have been observed, causing dynamic joint stiffness and inhibiting optimal function. Coactivation may also increase joint contact force and accelerate degeneration. In healthy individuals, even if muscle weakness and atrophy occur due to disuse of muscle groups, muscle strength and mass can usually be improved through strength training, thereby improving neuromuscular prognosis. Unfortunately, muscle atrophy associated with arthrogenic muscle inhibition (AMI), like conventional disuse muscle atrophy, does not respond to conventional therapeutic exercises, making the failure of postoperative rehabilitation programs inevitable.

[0022] Therefore, AMI accounts for many of the problems associated with injury rehabilitation. Therapeutic exercise is not sufficiently effective in a state of motor neuron pool inhibition, and AMI is largely unresponsive to conventional muscle strengthening-based rehabilitation. Neuronal inhibition causes many rehabilitation problems in patients, leading to muscle weakness, atrophy, and impaired neuromuscular control, and thus to poor patient prognosis. To date, appropriate therapeutic interventions for AMI have not been established among researchers.

[0023] Numerous interventions have been attempted to counteract the effects of AMI. These local knee treatments include joint cooling with ice, transcutaneous electrical nerve stimulation (TENS), neuromuscular electrical stimulation (NMES), blood flow restriction, and eccentric exercise of the unaffected limb. As previously mentioned, conventional rehabilitation exercises are ineffective in treating AMI. Sonnery-Cottet et al. conducted a literature review on AMI after anterior cruciate ligament (ACL) reconstruction in 2019 ("Sonnery-Cottet et al. Arthrogenic muscle inhibition after ACL reconstruction: a scoping review of the efficacy of interventions Br J Sports Med 2019 53: 289-298"). In a simple randomized clinical trial of TENS in ACL rupture patients cited by Sonnelly Cotet et al., no differences were observed in isometric muscle strength or quadriceps central activation rate among the three groups (exercise only, exercise + TENS, and a group receiving 20 minutes of cryotherapy immediately before each exercise session). Significant improvements in quadriceps muscle strength were observed in all groups, and the effect size suggested a potential clinical benefit for patients with acute anterior cruciate ligament injury, but disinhibition did not outweigh the effect of exercise therapy alone. In a laboratory-based randomized trial, TENS disinhibited the quadriceps motor neuron pool during treatment, but this beneficial effect disappeared 30 minutes after discontinuation of treatment.

[0024] Traditional treatment approaches, such as muscle-strengthening-based rehabilitation programs, are largely ineffective for AMI patients and perpetuate poor clinical outcomes. Therefore, the conventional long-term prognosis for AMI patients is unfortunately poor. As discussed by leading AMI researcher Lindsey Lepley in a podcast recorded in April 2022, due to various challenges in treating AMI patients, the AMI research community is now focusing on the use of very high levels of electrical stimulation to localized areas above the patient's pain threshold. This is a return to a failed approach from the 1980s, as all other conventional AMI treatments have been exhausted.

[0025] To summarize, conventional rehabilitation still fails to show effects in many patients and cannot fully restore neuromuscular control, leading to persistent complications and poor outcomes including reoperation and recurrence. Furthermore, many patients develop AMI after injury for which there are currently no effective treatment methods. Therefore, there is a need to provide methods, systems, and devices for evaluating and quantifying neuromuscular control in order to enable the development of more effective treatment methods and rehabilitation programs, or at least to provide useful alternatives to existing methods, devices, and systems.

Summary of the Invention

Means for Solving the Problems

[0026] Methods, systems, and apparatus for implementing neuromodulatory therapy, as well as embodiments for evaluating neuromuscular control of musculoskeletal joints, are described below with reference to the drawings. Neuromodulatory therapy, abbreviated as NMT for convenience, encompasses a broad range. NMT may be used as a treatment or to evaluate the progress of treatment. This includes rehabilitation therapies or applications in which NMT is used to restore an injured joint or neuromuscular system to its previous state and functional level, or to at least improve from the injured state, even if full function cannot be restored. NMT also broadly encompasses therapies to achieve a higher functional state that was maintained before treatment. This is broader than rehabilitation and may be used by patients to manage their own condition or by those aiming for the development or improvement of their abilities. For example, children with cerebral palsy can use NMT to help manage their condition, but this is not strictly classified as rehabilitation. Also, children or amateur athletes can use embodiments of NMT described herein to accelerate the development of motor skills and function, thereby reaching desired abilities in a more targeted, faster, and better way. Therefore, developmental applications may include the optimization and enhancement of abilities. For example, an elite athlete or other person may use an embodiment of NMT to perform highly relevant and targeted motor skills training and fine-tune the neuromuscular control of specific joints and neuromuscular systems, thereby increasing the probability of achieving accuracy in outcome-based tasks (i.e., achieving optimal ability). Therefore, it should be understood that the methods of providing NMT described herein, and the associated systems or devices, can be used for a wide range of applications, including rehabilitation, development, and ability optimization. In the following discussion, it should be understood that the term NMT is used broadly to refer to any of these applications.

[0027] Embodiments of the methods described herein can be used to assess or identify specific parameter ranges in which a person (e.g., patient or athlete) has insufficient neuromuscular control (e.g., force exerted, timing, coordination, or specific movement / joint angles), and to improve neuromuscular control using neuromodulatory therapies, including repetitive movements. NMT can be used for both medical and non-medical purposes, and in this specification, the terms user, patient, person, and athlete are used interchangeably to refer to a person receiving NMT or using an NMT device. The repetitive movements described herein can form the basis of a rehabilitation program, or equivalent rehabilitation method or therapy, designed to retrain the brain to adapt to or learn a new signaling environment in order to restore control and functionality. That is, such a rehabilitation program is structured to focus on areas of insufficient neuromuscular control in the user, rather than on muscle strengthening, and can provide an improved assessment method and / or enable the development of more targeted rehabilitation programs that are more likely to lead to improved or complete recovery. Embodiments of such rehabilitation programs can be used to treat arthrogenic muscle inhibition, increase the recruitment of muscle motor units, reduce muscle fatigue (and cognitive fatigue typically seen in those with the aforementioned problems), and optimize the abilities of individuals requiring high levels of control, such as athletes, sports players, and dancers. Further embodiments of NMT can be used to assess the progression of neurodegenerative diseases such as Parkinson's disease, Duchenne muscular dystrophy (DMD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and many other debilitating diseases. The progression of such diseases can be tracked by performing assessments of neuromuscular control at different stages, which allows for the evaluation of the effectiveness of treatments (including rehabilitation programs). Furthermore, neuromodulatory therapy is applicable to the treatment of several neurodegenerative diseases to at least slow the progression of these conditions. Similarly, NMT can be used to assess whether a user is suffering from mild cognitive impairment, such as concussion.Furthermore, embodiments of the method of the present disclosure enable the assessment of the degree to which a user suffers from cognitive impairment by comparing differences in neuromuscular control obtained under conditions where cognitive load varies. Embodiments of systems and devices for implementing embodiments of NMT to evaluate neuromuscular control are also described herein.

[0028] In a first aspect, according to the present disclosure, a method for providing a neuromodulation therapy (NMT) comprises instructing a user to perform a plurality of movements including movements of at least one target musculoskeletal joint and / or instructing using a device, the plurality of movements including one or more feed-forward movements; providing a user with a presentation of one or more target parameters for at least one of the plurality of movements, at least one of the plurality of movements including one or more feed-forward movements, the presentation of the target parameters being provided over one or more presentation periods during the performance of each movement, and the presentation of the target parameters during the performance of the feed-forward movement being occluded for at least a portion of the presentation period; measuring one or more target parameters over one or more capture periods while the user is performing at least one of the plurality of movements; and providing a feedback presentation to the user using the measured one or more target parameters.

[0029] In other words, each exercise has a duration that includes one or more presentation periods. As will be described later, each exercise does not need to be performed over the entire duration, and a specific part of the exercise can be targeted. The presentation period is the net period during which the presentation of the target parameter is provided. However, during the performance of a feedforward exercise, the presentation of the target parameter is shielded (e.g., not presented, suppressed, not presented) for at least a portion of the presentation period. In other words, during the performance of a feedforward exercise, the presentation of the target parameter is not provided for the entire duration of the presentation period. Instead, the presentation period is the net period during which the presentation of the target parameter is provided. The shielded portion is one or more shielding periods, and the shielded period is a subset (part) of the presentation period. As will be described later, the shielded portion can be changed for each exercise. Therefore, the presentation period can be defined as one or more periods during the exercise in which the presentation of one or more target parameters may be provided. A feedforward exercise can be defined as an exercise in which the presentation of one or more target parameters is provided. The presentation of one or more target parameters during a feedforward motion is shielded for one or more shielding periods within one or more presentation periods. In the context of this specification, feedforward is a label for a type of motion, and a feedforward motion can be considered a motion in which the presentation of one or more target parameters is shielded for one or more shielding periods within the presentation period. The capture period is the time frame in which the target parameters are actually measured. The time frame of the capture period may be the same as, but does not have to be, the same as, the time frame of the presentation period. The capture period usually includes at least several shielding time frames, or a portion of a shielding time frame.

[0030] In one embodiment, the user is instructed to attempt to match one or more target parameters in real time over one or more presentation periods, each movement consisting of one or more actions, and each presentation period being a period for performing at least one complete action.

[0031] In one embodiment, at least one of a plurality of movements further includes at least one feedback movement, and the presentation of a target parameter during the performance of the feedback movement is provided over the entire duration of the presentation period.

[0032] In one embodiment, the method of the present disclosure includes the step of evaluating the neuromuscular control of at least one target musculoskeletal joint during the performance of at least one of a plurality of movements, further comprising determining one or more differences between one or more target parameters and their measured values ​​over one or more capture periods.

[0033] In one embodiment, the evaluation is used to trigger a change in the occlusion of the presentation of a target parameter during a portion of one or more presentation periods while a feedforward motion is being performed, and the evaluation is used to change the phase, duration, or complexity of the occlusion of the presentation of the target parameter.

[0034] In a further embodiment, preferably, the evaluation includes determining one or more accuracy measures using one or more differences, the one or more accuracy measures being compared to one or more predetermined trigger thresholds to trigger a phase change that obscures the presentation of a target parameter over one or more presentation periods.

[0035] In a further embodiment, a difference of 1 or more is compared to one of one or more predetermined difference thresholds, and a precision measurement of 1 or more is an estimate of the proportion of time during each exercise in which a difference of 1 or more falls within a range of 1 or more differences, the range of 1 or more differences is defined by one or more difference thresholds.

[0036] In a further embodiment, the method of the present disclosure further includes the step of electronically reporting an evaluation of neuromuscular control of at least one target musculoskeletal joint.

[0037] In a second aspect, the present disclosure provides a method for evaluating neuromuscular control of at least one target musculoskeletal joint, comprising: instructing a user to perform one or more movements, including movement of at least one target musculoskeletal joint, and / or using a device to do so; providing the user with a presentation of one or more target parameters for at least one of the one or more movements over one or more presentation periods, wherein the user is instructed to attempt to match the one or more target parameters in real time; measuring the one or more target parameters as a function of time over one or more capture periods while the user is performing the one or more movements; determining one or more differences between the one or more target parameters and the measured values ​​over one or more capture periods; and using the one or more differences to create an evaluation of neuromuscular control of at least one target musculoskeletal joint, and electronically reporting the evaluation created.

[0038] In one embodiment, the evaluation further includes determining one or more of the following using a difference of 1 or more: a measure of smoothness of motion, an error summary, and a control summary, which include one or more ranges of one or more target parameters and / or one or more joint angle ranges of the user, in cases where the user lacks control of at least one target musculoskeletal joint.

[0039] In one embodiment, the step of determining one or more differences includes calculating one or more measurement errors by comparing one or more target parameters with their measured values ​​over one or more capture periods, and the method of the present disclosure further includes performing a statistical analysis of the one or more measurement errors to characterize the locations where the user lacks control of at least one target musculoskeletal joint.

[0040] In one embodiment, each movement comprises one or more motions, each motion being either a dynamic motion involving moving one or more muscles associated with at least one target musculoskeletal joint to move at least one target musculoskeletal joint over one or more joint angle ranges, or a static motion involving moving one or more muscles associated with at least one target musculoskeletal joint while holding at least one target musculoskeletal joint in a resting position at a fixed joint angle.

[0041] In one embodiment, the target parameter changes over at least one of one or more presentation periods. This can occur during a single movement or over multiple coordinated movements performed over one or more presentation periods. In another embodiment, the target parameter remains constant over at least one of one or more presentation periods. This, too, can occur during a single movement or over multiple coordinated movements performed over one or more presentation periods. In one embodiment, each movement may involve moving a plurality of musculoskeletal joints, including at least one target musculoskeletal joint, over a defined range of motion, and / or moving a specific muscle or muscle group associated with at least one target musculoskeletal joint.

[0042] In one embodiment, the presentation of target parameters is provided to the user as a function of time. This is done via one or more of the following: visual, auditory, or tactile devices. This ensures that the presentation of target parameters during each movement is provided as a function of time. Visual presentations include target levels, target curves, numerical values, shapes with variable characteristics such as size and color, etc. Visual presentations may also include charts, sliders, gauges, or other visual presentations displayed on computer monitors, tablet screens, mobile phone screens, wearable glasses screens, or other visual devices. Auditory devices include speakers in headphones, portable speakers, computer devices, tablets, smartphones, etc., which represent target parameters using volume and pitch, and indicate the degree of achievement of the target parameters to the user through changes in volume and pitch. Tactile devices provide the presentation of target parameters using predetermined tactile intensity and / or frequency.

[0043] In one embodiment, the method of the present disclosure further includes the step of providing a presentation of measurement parameters as a function of time (including real time). Specifically, the difference between the target value and the measured value may be presented graphically, or an instantaneous constant value of the target parameter may be presented alone, or the difference may be presented superimposed on a visual presentation of the target parameter. In another embodiment, the difference between the target parameter and the measured target parameter may be represented by changes in the pitch or volume of an audible sound, or by changes in the frequency and / or amplitude of tactile feedback.

[0044] In one embodiment, the target parameter may change predictably or unpredictably according to a periodic function such as a sinusoidal function, a sawtooth wave function, a trigonometric function, a polynomial function, a parametric function, or any other predictable method. The presentation of the target parameter may change predictably and may be shielded for one or more shielding periods (i.e., blank periods). In one embodiment, the feedback presentation includes a real-time presentation of a measurement of the target parameter. The target parameter may be presented in a short timeframe prior to the current time, or may be changed without the user's prior knowledge to test the user's ability and response time to track the target parameter. If the target parameter is presented audibly, the audible presentation of the target parameter may be partially or completely shielded. Also, if the target parameter is presented audibly, the audible presentation of the target parameter may be provided in such a way that blank periods (i.e., periods during which the audio signal is blocked) occur. In one embodiment, one or more movements include multiple movements, and the presentation of target parameters for each sequential movement in the multiple movements is obscured according to a series of occlusions. The user is instructed to perform each movement individually or to perform other movements. That is, one or more movements, together with other movements, include multiple movements that follow a series of occlusion sequences. Each occlusion in the series of occlusions has a different occlusion period. For example, the occlusion period (blank period) may be constant, but the position or phase range of the occlusion may change. In one embodiment, the series of occlusions may be a progression of occlusion from no occlusion to complete occlusion in a predetermined order (or vice versa). That is, each occlusion in the series of occlusion sequences may have an increasingly longer occlusion period (blank period) or an increasingly complex occlusion (or vice versa). Partial occlusion or progression of occlusion may be configured such that a future target value is presented after the occlusion period (blank period) has elapsed, thereby requiring the user to predict the amount of force required to achieve the target value. Multiple exercises are divided into multiple sessions, each session containing one or more sets (or trials, repetitions) of one or more exercises.At least 80% of the movements included in the session are transitioned over time from feedback movements to feedforward movements, and the amount and complexity of the shielding of the presentation of the target parameter during the performance of the feedforward movements are increased over time (or vice versa). The amount and complexity of the shielding are increased until the presentation of the target parameter is 100% shielded, and during the performance of each movement, only feedback presentations using the measured target parameter are presented, and during the performance of each subsequent movement, the feedback presentations are also shielded. In one embodiment, the presentation of the target parameter is a sinusoidal curve of force that has a curve period and changes sinusoidally, and increasing the amount and complexity of the shielding of the presentation of the target parameter during the performance of the feedforward movements over time includes starting by shielding the central portion of the sinusoidal curve for a first period of less than 20% of the curve period, then extending the first period, then shielding the inflection point of the sinusoidal curve, and then gradually increasing the percentage of the curve period that is shielded until the sinusoidal curve is 100% shielded.

[0045] Multiple exercises can be structured as a program such as a rehabilitation program, a treatment program, or an exercise program, in which multiple exercises are divided into multiple sessions, each session containing one or more sets of one or more exercises. During a baseline session, an assessment of neuromuscular control is performed, which includes determining one or more ranges of target parameters and / or one or more joint angle ranges of the user at the site where the user lacks control of at least one target musculoskeletal joint, and in subsequent sessions, one or more sets of one or more exercises instructed by the user or the device are selected using the one or more ranges of target parameters and / or one or more joint angle ranges of the user at the site where the user lacks control of at least one target musculoskeletal joint, as determined in the assessment. Furthermore, the assessment of neuromuscular control of at least one target musculoskeletal joint may be performed again in the baseline session and one or more subsequent sessions to evaluate one or more measures of treatment progress, rehabilitation program progress, development program progress, ability optimization program progress, and neurological impairment progression, and to assess whether the user suffers from mild cognitive impairment. For example, the progression of neurodegenerative diseases can be assessed by measuring changes in neuromuscular control over time. For instance, the method of the Disclosure may be performed in a baseline session to obtain a baseline set or baseline assessment of the difference in neuromuscular control, and then the method of the Disclosure may be performed again in a subsequent session (i.e., at a later time point) to assess the changes by comparing the measured difference or assessment of neuromuscular control with the difference or assessment obtained in the baseline session. In one embodiment, at least one set of exercises during a session is more difficult than other sets of exercises in the same session in order to impose a higher cognitive load on the user, and the assessment of whether or not the user suffers from mild cognitive impairment is based on the difference obtained when the user is subjected to a higher cognitive load.

[0046] In one embodiment, the method of the present disclosure further includes the steps of measuring the joint angle of at least one target musculoskeletal joint as a function of time, and determining one or more ranges of the measured target parameter and / or one or more joint angle ranges. The above step of determining one or more joint angle ranges includes determining one or more joint angle ranges corresponding to one or more parameter ranges that lack control of at least one target musculoskeletal joint. The determination of the joint angles may be performed by geometric calculations based on the relevant device, or by analysis of synchronized video analysis of the user's movements captured by image sensors during multiple movements. In this embodiment, the method of the present disclosure further includes recording the user's movements using one or more image sensors, such as one or more cameras, and performing motion capture and analysis of the user's movements using motion capture software running on a computer device. The software may be configured to create a presentation of the user's ability to track the target parameter and to determine deviations from the target parameter over time. The computer program product may be an application downloaded to a user computer device that establishes a communication link with other devices, such as a portable load cell device.

[0047] In one embodiment, the method of the present disclosure further includes a preliminary step of determining the maximum achievable reference value for a target parameter, the target parameter varying as a percentage of the measured maximum achievable reference value. For example, the maximum achievable reference value may be the user's maximum muscle strength, the user's minimum muscle strength, or a statistically derived or related strength index, if the selected parameter is a force measurement. It will be apparent to those skilled in the art that this is also applicable to other parameters. Such parameters include, but are not limited to, range of motion, range of motion, smoothness of motion (e.g., gait analysis), speed of motion, change of direction, type of muscle contraction (e.g., concentric or eccentric), muscle fatigue, total momentum, smoothness / awkwardness of control, precision, length of the viewing window, partial occlusion of the target path, derivative of displacement, relative reference of the parameter, or a combination of the maximum achievable value or statistically derived value corresponding thereto. The target parameter can then be varied within the range of the maximum achievable value. This can be done across the entire range from 0% to 100% of the measured maximum achievable value (with some tolerance allowed, as the user's ability may improve beyond the measured baseline level of 100%). In this way, all measurements after the evaluation period of the degree of control of the target joint or group of joints can be correlated to the maximum achievable value of the specific parameter during the evaluation period. In one embodiment, the maximum achievable value can be used as a baseline to quantify the progress of musculoskeletal control over time. Alternatively, a lower limit may be set, and the target parameter may be varied from that lower limit to the maximum achievable value. The lower limit may be determined from the measurements used to determine the maximum achievable value (e.g., 10%, 25%), from an estimate of the control range (e.g., an estimate based on past control range evaluations), or from a predetermined value.

[0048] In another embodiment, the method of the present disclosure further includes a preliminary step of estimating the maximum achievable threshold for a given parameter for a user based on the user's physiological characteristics, age, sex, or a combination thereof, and the target parameter can be varied within a range from a lower limit (e.g., 0, 10%, 20%) to an upper limit determined based on the estimated maximum achievable threshold. In some embodiments, the upper limit may be 100% of the estimated maximum achievable threshold, or it may be a value exceeding 100% of the estimated threshold (e.g., 110%, 120%) to accommodate users who exhibit above-average neuromuscular control.

[0049] In another embodiment, the method of the present disclosure further includes a preliminary step of referring to a past measurement of the maximum achievable value of a given parameter for a user, and the target parameter can be varied within a range from a lower limit (e.g., 0, 5%, 10%, 20%) to an upper limit determined based on the previously measured maximum achievable parameter. In one embodiment, the upper limit may be 100% of the previously measured maximum achievable baseline, or it may be a value exceeding 100% of the past measurement (e.g., 110%, 120%) to accommodate a user with improved neuromuscular and / or control abilities.

[0050] In a further embodiment, in a first group of one or more sets of one or more movements, the target parameter changes unpredictably, and the level of the target parameter is presented in a short time frame prior to the current time, while in a subsequent group of one or more sets of one or more movements, the target force level changes predictably or is presented in a long time frame prior to the current time.

[0051] In another embodiment, by simultaneously measuring multiple parameters during a user's exercise and analyzing these simultaneously measured parameters, additional insights into the musculoskeletal system and specific compound movements defined by the exercise can be provided. In yet another embodiment, additional measurements can be extracted from the measured target parameters, such as subsets of data, statistics on repetitions, values ​​comparing the target parameter with the measured target parameter, and statistics on selected subsets of data (e.g., extension phase in extension / flexion movements, or acceleration phase of the extension phase).

[0052] In one embodiment, the measurement of target parameters includes the measurement of multiple parameters in both dynamic and static control of a joint or group of joints. In a non-limiting example, dynamic control includes applying a constant force to an apparatus while performing a defined series of movements. For example, applying a constant or fluctuating force (or torque) to a cycling machine by continuously moving the legs in a constant cycling motion. This can also be done by changing the direction and speed of pedaling; that is, pedaling quickly in the forward direction, decelerating to a controlled stop, and then pedaling quickly in the reverse direction (or vice versa). In another non-limiting example, static control includes applying a constant or fluctuating force to a force plate while holding the leg joints in a fixed position.

[0053] In one embodiment, the measurement of target parameters further includes the measurement of one or more parameters of a subset of measurements of one or more exercises performed repeatedly over a period of time to determine an index of decreased stamina and control due to neuromuscular fatigue. Such time-series data indicating decreased ability may indicate both cognitive and / or physiological fatigue. In another embodiment, the method of the present disclosure includes a time-series static measurement of one or more parameters to determine an index of decreased stamina and control due to neuromuscular fatigue. Generally, fatigue is a useful monitoring parameter and may provide deeper insights due to local factors such as decreased motor unit recruitment rate and decreased rate coding (motor unit firing rate). Thus, fatigue may lead to difficulty in maintaining a steady state and increased variability in target accuracy. Fatigue may also alter gamma loop sensitivity and affect the corticospinal and cortical drive systems (via the cerebellum), causing central effects. In one embodiment, the target parameters may be force, motion velocity, acceleration, or other motion measurements to a force plate sensor during static measurement or during dynamic movement. Similarly (or additionally), the target parameter may be the positional accuracy of one or more joints, either at rest or during movement, under a constant or varying load. The presentation of the measured parameter may be provided in real time (i.e., the target parameter and the actual measured target parameter are presented) to provide real-time feedback to the user during the performance of the movement. In this way, an expression of error or lack of control is provided to the user, thereby forming a feedback mechanism that allows the user to adjust neuromuscular control to reduce the error. By analyzing the difference between the target parameter and the measured parameter as a function of time, either statically or during movement, the user can gain insights into the muscle groups or joint angles where control of at least one target musculoskeletal joint is lacking. Furthermore, the type of error signal, frequency, control loop delay, and relative differences in control ability as the parameter level increases or decreases provide insights into the lack of control and its potential mechanisms.This allows clinicians to gain deeper insights into designing rehabilitation programs that focus on specific neuromuscular problems.

[0054] In one embodiment, one or more exercises are divided into a baseline session and one or more subsequent sessions, and the evaluation of neuromuscular control includes comparing one or more differences determined in the final session of at least one or more subsequent sessions with one or more differences determined in the baseline session, thereby determining whether the user has mild cognitive impairment or assessing the progression of neurological impairment. The determination of whether the user has mild cognitive impairment and the assessment of the progression of cognitive impairment can be performed by comparing differences in neuromuscular control obtained at two different points in time, or at times when the user is under different cognitive loads. Therefore, in one embodiment, at least one set of exercises in a session is made more difficult than other sets of exercises in the same session in order to impose a higher cognitive load on the user, and the evaluation of whether the user has mild cognitive impairment is performed based on the difference obtained when the user is subjected to a higher cognitive load. The cognitive load does not need to be related to muscles.

[0055] In one embodiment, a baseline session is obtained from a user who provides past baseline measurements and performs the same assessment when they are not suffering from mild cognitive impairment or in the early stages of cognitive decline, such as after an initial diagnosis. Since the cognitive decline process is usually monotonous, the baseline of cognitive function can be obtained at any stage of decline.

[0056] In one embodiment, cognitive loading can be achieved by requiring the user to perform a mental cognitive task. This task may involve working backward from 100 in increments of 7 (or using other combinations of numbers so that the user cannot learn the sequence and deceive the system). In another embodiment, as an alternative, it can be achieved by requiring the user to describe a specified scene. An example is having the user describe the face of a clock displaying a specified time. In yet another embodiment, an alternative is having the user perform a specific pattern recognition or matching task. In yet another embodiment, an alternative is changing the color of a predetermined pattern of target parameter presentation on a visual display device, or additionally presenting multiple different patterns on the visual display device. Various cognitive loading techniques can be applied as alternatives, and it is also possible to determine whether the user is truly experiencing cognitive loading during these tasks by comparing the user's abilities between sessions and cross-correlating them with measures of neuromuscular control. Thus, mild cognitive impairment can be assessed based on the extent to which factors such as arthrogenic muscle inhibition and neuromuscular control of target joints are affected by cognitive loading.

[0057] In one embodiment, the above steps instructing the user further include playing one or both of the audible and tactile sequences while the user is performing an exercise, and the method of the present disclosure further includes playing one or both of the audible and tactile sequences when the user is not engaged in a cognitively demanding task. In one embodiment, the playing of one or both of the audible and tactile sequences is performed while the user is asleep (e.g., passive memory reactivation). The audible and / or tactile sequences are also played in conjunction with a visual presentation of target parameters and / or measured target parameters, allowing a correlation to be established between the visual and auditory cues. In one embodiment, one or both of the audible and tactile sequences are played while the user is asleep to reactivate past memories and enhance neuromuscular control.

[0058] In one embodiment, one or more exercises are performed by a user using a neuromodulatory therapy device having a resistance element and a sensing device configured to measure one or more target parameters as a function of time over one or more capture periods while the user performs one or more exercises. A computer device performs steps of instructing the user, providing target parameters, providing feedback, determining the one or more differences described above, and creating and reporting an evaluation. The computer device is capable of communicating with the sensing device that provides the measured values ​​of one or more target parameters.

[0059] In one embodiment, the computer device is a mobile computer device including a display device configured to display one or more target parameters as a function of time, and is configured to receive measurements from a sensing device in real time. The mobile computer device may be a personal computer, a laptop computer, a tablet, a smartphone, smart glasses, a dedicated microcontroller-based device, or other application-specific computer device. The computer device may be integrated with the extension device, or may be operably connected to the sensing device via a wired or wireless communication link and configured to display feedback presentations using the display device.

[0060] In one embodiment, the target parameter is force, which is measured by one or more load cells connected to one or more resistive elements. The one or more load cells may be integrated into neuromodulatory therapy (NMT). The load cells may be portable load cells configured to wirelessly transmit the measured force data to a computer device. The portable load cells may include a mounting mechanism for attaching one end of one or more resistive elements to one or more mounting points on an NMT extension device. The user may be instructed to apply one or more forces to the load cells. This instruction may be displayed on a display device of the computer device as a visual graph showing the relationship between one or more forces and time. Similarly, the user may be instructed to apply a predetermined force by one or more audio signals. The force may be represented as an audio tone, or the frequency of the audio signal may represent the level of force required (e.g., an increase in frequency or pitch instructs the user to increase the force applied). It will be apparent to those skilled in the art that various visual graphical displays, acoustic technologies, tactile feedback, or other forms of instruction / feedback can be optionally applied to instruct the user on the required level of force to apply.

[0061] In another embodiment, the computer device is further configured to upload data including at least an assessment of neuromuscular control to an external data storage location. In one embodiment, the computer device further comprises an external interface configured to provide connectivity to an external computer or other computing resources such as cloud storage or processing resources via any commonly used interface or protocol. In this case, data related to an assessment of a given user is uploaded to an external data storage location (e.g., an external database, a cloud storage device, or some form of archive, but not limited to these). This enables the system of the disclosure to maintain a long-term memory of a given user's capabilities over time. Data archiving and mining make it possible to derive summary statistics, progression, compliance, and other data for a given patient, a given patient cohort, or any other demographic subset of patients.

[0062] In one embodiment, the sensing device includes a computer vision system configured to capture and measure the user's joint angles during the performance of a movement. The computer vision system may be configured to capture position and / or posture data of at least one target musculoskeletal joint and one or more associated limbs during the performance of the movement. The computer device then uses the position and / or posture data and synchronously measured force measurements to estimate the torque (force) applied during the performance of the movement as a function of time. In one embodiment, the computer device may be further configured to generate one or more plots representing the three-dimensional range of motion of at least one target musculoskeletal joint and the associated control level.

[0063] In one embodiment, the sensing device includes a digital goniometer configured to measure the user's joint angles when worn by the user. In another embodiment, the sensing device comprises a force sensing device having a force sensor, an inertial measuring unit (IMU), and a communication module, the communication module being configured to wirelessly transmit force data and posture data measured by the force sensor and the inertial measuring unit (IMU) to a computer device in order to estimate the force applied by the user during movement and the user's joint angles as a function of time. The sensing device may include a plurality of sensing devices, including combinations of the above.

[0064] In one embodiment, the above step of using the device to instruct a user includes attaching the end effector of a collaborative robot (cobot) to the user, the end effector includes a force sensor, the collaborative robot is programmed to follow a predetermined path during the performance of a movement, the user is instructed to move one or more muscles associated with at least one target musculoskeletal joint to provide a reaction force during the performance of the movement, and the collaborative robot includes one or more force measuring devices (force sensors) to measure the reaction force applied by the user during the performance of the movement.

[0065] In another embodiment, a force measuring device is attached to the user. The force measuring device is firmly attached to the end effector of the collaborative robot. The user is instructed to perform one or more movements (i.e., movements along a predetermined path). Meanwhile, the collaborative robot is instructed to provide a programmed resistance profile for the user's movements as measured by the force measuring device. According to this embodiment, the programmed resistance profile may be a constant force, a joint angle-dependent force, a smoothly changing force (such as a sine wave), or an arbitrarily changing force.

[0066] In another embodiment, the collaborative robot is a 6-degree-of-freedom collaborative robot configured to move at least one target musculoskeletal joint over its entire range of motion in multiplane joint movement, or the collaborative robot is configured to move multiple combinations of joints, including at least one target musculoskeletal joint, simultaneously in multiplane joint movement, and the reaction force applied by the user during the performance of the multiplane joint movement is measured by the collaborative robot.

[0067] In another embodiment, user force data and joint angle data measured during the execution of a movement are stored, and the collaborative robot is configured to reproduce a previously performed movement using the stored force data and joint angle data. The user force data and joint angle data measured during the execution of the movement reproduced by the collaborative robot are compared with the stored force data and joint angle data to evaluate changes in the control of at least one target musculoskeletal joint.

[0068] In yet another embodiment, the collaborative robot stores or determines motion and force envelope thresholds for a motion and generates a warning if the user's force and / or position measured during the motion is outside the range of the motion and force envelope thresholds for the motion.

[0069] In another embodiment, the collaborative robot is configured to maintain a force sensor perpendicular to the point of contact with the user while performing one or more movements.

[0070] In one embodiment, one or more movements include a set of simultaneous movements performed by multiple musculoskeletal joints, each of which has distinct target parameters as a function of time.

[0071] In yet another embodiment, the method of the present disclosure further includes the step of creating one or more plots representing the range of motion of at least one target musculoskeletal joint in three dimensions and the associated control levels.

[0072] In yet another embodiment, one or more movements include multiple combinations of multi-plane joint movements. The above step of creating one or more plots representing the range of motion of at least one target musculoskeletal joint in three dimensions and the associated level of control includes indicating the range associated with performing a functional task using at least one target musculoskeletal joint.

[0073] In yet another embodiment, the method of the present disclosure further includes the steps of repeating the method for a musculoskeletal joint contralateral to at least one target musculoskeletal joint, and creating a comparison of control levels for a musculoskeletal joint contralateral to at least one target musculoskeletal joint.

[0074] In yet another embodiment, the method of the disclosure further includes the steps of determining a rehabilitation plan based on one or more force ranges at a location where the user lacks control of at least one target musculoskeletal joint, and periodically repeating the method of the disclosure to evaluate the degree of improvement at at least one target musculoskeletal joint.

[0075] In one embodiment, the multiple movements include one or more equilibrium movements. One or more equilibrium movements include the user remaining still in a first posture, and one or more target parameters include deviations from an initial position. The first posture includes a single-leg standing posture, a double-leg standing posture, a seated posture, or a kneeling posture. The first posture is performed on a surface on which the user can be displaced in the pitch, roll, and / or yaw directions. The first posture is also performed while the user is viewing a moving field of view. The user is instructed to remain still in the first posture for a first period with their eyes open, and then to remain still in the first posture for a second period with their eyes closed. One or more equilibrium movements include one or more swaying movements, and the user is instructed to follow a swaying pattern that sways at a predetermined speed along a predetermined path, and the target parameter is the deviation from the swaying pattern.

[0076] A modified embodiment of the NMT method of this disclosure, used for evaluating equilibrium, includes the steps of: instructing a user and / or using an apparatus to maintain a stationary state for one or more periods; measuring one or more target parameters as a function of time for one or more capture periods within the one or more periods; calculating one or more differences between one or more target parameters and their measured values ​​for one or more capture periods; and using the produced one or more differences to create and electronically report an evaluation of the user's equilibrium. The presentation of one or more target parameters is provided over one or more periods. Any form and modification described above in relation to the first embodiment can be used in this evaluation method.

[0077] In a third aspect, the present disclosure provides a computer program product that includes instructions for causing a processor to perform the method described in the first or second aspect.

[0078] In a fourth aspect, the present disclosure provides a neuromodulatory therapy (NMT) system comprising: a neuromodulatory therapy device including at least a resistance element; a sensing device including at least one sensor configured to measure one or more target parameters when a user is performing exercise using the neuromodulatory therapy device; one or more output devices configured to output one or more presentations of one or more target parameters; and a computer device including at least one processor, memory, and a communication interface, wherein the communication interface is configured to receive measurements of one or more target parameters from the sensing device; at least one processor is configured to control one or more output devices; and the memory stores instructions that configure at least one processor to perform the method described in the first or second aspect.

[0079] The system of this disclosure may include the above-mentioned sensing device (sensor device), load cell, and collaborative robot configuration.

[0080] In a fifth aspect, the present disclosure provides a neuromodulatory therapy (NMT) device comprising at least one resistance element and a sensing device including at least one sensor configured to measure one or more target parameters when a user is performing exercise using the device of the present disclosure, wherein the sensing device is configured to provide measurements of one or more target parameters to a computer device including at least one processor, memory, and a communication interface, the computer device being operably connected to or integrated with one or more output devices configured to output presentations of one or more target parameters, and the memory storing instructions that constitute the processor to perform the method according to any one of claims 1 to 60.

[0081] In a sixth aspect, the present disclosure provides a neuromodulatory therapy (NMT) kit comprising a neuromodulatory therapy (NMT) device as described in the fifth aspect, and a computer program product that includes instructions for a processor to perform the method described in either the first or second aspect. [Brief explanation of the drawing]

[0082] Embodiments of this disclosure will be described with reference to the accompanying drawings.

[0083] [Figure 1] Figure 1 is a schematic diagram of the three orthogonal planes of the human body used in medical imaging. [Figure 2A] Figure 2A is a schematic diagram of the main bone groups. [Figure 2B] Figure 2B is a schematic diagram of the major muscle groups. [Figure 3A] Figure 3A is a schematic diagram of a typical healthy motor neuron pool, showing the multiple individual motor units it contains. [Figure 3B] Figure 3B is a schematic diagram of the action potentials during a motor event in a healthy motor neuron pool. [Figure 4A]Figure 4A is a schematic diagram of a typical motor neuron pool where arthrogenic muscle inhibition occurs. [Figure 4B] Figure 4B is a schematic diagram of the action potentials during a motor event in a motor neuron pool where arthrogenic muscle inhibition occurs. [Figure 5A] Figure 5A is a schematic diagram of the main group of muscles in the thigh involved in extension of the lower leg, showing the state at rest. [Figure 5B] Figure 5B is a schematic diagram of the main group of muscles in the thigh involved in lower leg extension, showing the position during an exercise where the leg is lifted against resistance. [Figure 6] Figure 6 is a schematic diagram of the neural network of the cerebellum. [Figure 7] Figure 7 is a schematic diagram of the spinal reflex nerve pathways related to lower leg movement. [Figure 8A] Figure 8A is a sagittal schematic diagram 200 of a neuromodulatory therapy device configured for use in knee joint muscle training according to one embodiment. [Figure 8B] Figure 8B is a sagittal schematic diagram 220 of a leg press gym device configured to be used as an extension device according to one embodiment. [Figure 8C] Figure 8C is a perspective view of a neuromodulatory therapy device configured for use in knee joint muscle training using a sliding pedal, according to one embodiment. [Figure 8D] Figure 8D is a top view of the neuromodulatory therapy device shown in Figure 8C. [Figure 8E] Figure 8E is a side view of the neuromodulatory therapy device shown in Figure 8C. [Figure 8F] Figure 8F is a sagittal schematic diagram 225 of a neuromodulatory therapy device including an active resistance element, configured for use in knee joint muscle training according to one embodiment. [Figure 9A] Figure 9A is a schematic diagram of a neural control device in the form of a conventional cycling machine or exercise bicycle, according to one embodiment. [Figure 9B]Figure 9B is a schematic diagram 230 of a nerve control device in the form of a pedal set according to one embodiment. [Figure 9C] Figure 9C is a side view of a pedal set having a fixed-length crank arm according to one embodiment. [Figure 9D] Figure 9D is a side view showing the rotational state of a pedal set having a variable-length crank arm according to one embodiment. [Figure 10] Figure 10 is a sagittal schematic diagram 240 of another extension device having the same function as the extension device in Figure 9, according to one embodiment, and shows only the elements that are functionally equivalent to the extension device in Figure 9. [Figure 11] Figure 11 is a schematic diagram 250 of a force measuring device according to one embodiment. [Figure 12] Figure 12 is a sagittal schematic diagram 280 of a portable neuromodulator configured for use in an office environment, according to one embodiment. [Figure 13A] Figure 13A is a schematic diagram 290 of a portable extension device according to one embodiment. [Figure 13B] Figure 13B is a schematic diagram 300 of a portable extension device according to one embodiment. [Figure 14] Figure 14 is a schematic diagram 320 of a computer device to which a sensor of a nerve modulation and extension device is connected and information is transmitted, according to one embodiment. [Figure 15] Figure 15(a) is a schematic diagram 350 of a predetermined pattern presented to the user according to one embodiment. Figure 15(b) is a schematic diagram 370 showing a subsequent point in time following the predetermined pattern in Figure 15A, according to one embodiment. [Figure 16A] Figure 16A is a schematic diagram 380 of a predetermined pattern presented to the user according to one embodiment. [Figure 16B] Figure 16B is a schematic diagram 390 of the patterns measured from users imitating a predetermined pattern during the capture period. [Figure 16C] Figure 16C is a schematic diagram 400 showing the error between the pattern measured by a user imitating the predetermined pattern (sine wave) shown in Figure 16A during the capture period and the predetermined pattern shown in Figure 16A. [Figure 16D] Figure 16D is a schematic diagram of the absolute error (i.e., the error coefficient shown in Figure 16C, but not on the same scale) according to one embodiment. [Figure 17] Figure 17 is a schematic diagram 430 showing a series of visual displays of a sinusoidally changing force pattern of a predetermined target, displayed on a visual display device according to one embodiment, in which different regions of the force pattern are obscured in each visual display. [Figure 18] Figure 18 is a schematic diagram 450 showing a series of visual representations of a sinusoidally changing force pattern of another predetermined target displayed on a visual display device according to one embodiment, where different regions of the force pattern are obscured in each visual representation. [Figure 19] Figure 19 is a schematic diagram 460 showing a sinusoidal force pattern of a predetermined target divided into four quadrants according to one embodiment. [Figure 20] Figure 20 is a schematic diagram of the temporal progression from feedback movement to feedforward movement in neuromodulatory therapy (NMT) according to one embodiment. [Figure 21] Figure 21 is a schematic diagram of a multi-day neuromodulatory therapy program according to one embodiment. [Figure 22] Figure 22 is a flowchart of a method for providing neuromodulatory therapy according to one embodiment. [Figure 23] Figure 23 is a flowchart of a method for evaluating neuromuscular control according to one embodiment. [Figure 24] Figure 24 is a flowchart illustrating a method for optimizing rehabilitation, development, or ability based on neuromodulatory therapy, according to one embodiment. [Figure 25A] Figure 25A is a schematic diagram of the results of an electromyography examination of an exemplary patient suffering from arthrogenic muscle suppression according to one embodiment. [Figure 25B] Figure 25B is a schematic diagram 600 of the results of an electromyography examination after the rehabilitation process of the exemplary patient shown in Figure 25A, according to one embodiment. [Figure 26A]Figure 26A is a sagittal plane schematic diagram 620 of a biceps brachii curl extension device applied to the elbow joint according to one embodiment. [Figure 26B] Figure 26B is a sagittal schematic diagram 640 of another extension device having the same function as the extension device of Figure 26A, according to one embodiment. [Figure 27A] Figure 27A is a sagittal schematic diagram 650 of a biceps curl extension device applied to the elbow joint according to one embodiment, which is configured to be fixed to the shoulder joint in order to enable a simple hinge movement of the elbow joint. Figure 27A shows the proximal member of the extension device held in a vertical position. [Figure 27B] Figure 27B is a sagittal plane schematic diagram 660 of a biceps brachii curl extension device applied to the elbow joint according to one embodiment, showing the proximal member of the extension device held in a horizontal position. [Figure 27C] Figure 27C is a sagittal plane schematic diagram 670 of a biceps brachii curl extension device applied to the elbow joint according to one embodiment, showing that the proximal member of the extension device is displaceable and that the wrist can move in a straight line in the sagittal plane. [Figure 28A] Figure 28A is a schematic diagram of a portion of an elbow extension device configured to allow two degrees of freedom of movement according to one embodiment. [Figure 28B] Figure 28B is a schematic diagram 710 showing a state in which the grip bar of the handle of the extension device shown in Figure 28A is grasped by the user's hand, according to one embodiment. [Figure 28C] Figure 28C is a schematic diagram 720 showing the distal end of the distal member of the extension device shown in Figure 28A rotated by approximately 90 degrees, according to one embodiment. [Figure 29A] Figure 29A is a sagittal schematic diagram 730 of an extension device configured to treat wrist flexion and extension according to one embodiment. [Figure 29B] Figure 29B is a sagittal schematic diagram 740 showing a state in which the wrist, gripping the extension device of Figure 29A, is extended, according to one embodiment. [Figure 29C]Figure 29C is a sagittal schematic diagram 750 showing a state in which the wrist is flexed while gripping the extension device of Figure 29A, according to one embodiment. [Figure 30] Figure 30 is a schematic diagram 770 of an extension device corresponding to the full range of motion of the wrist according to one embodiment. [Figure 31A] Figure 31A is a sagittal schematic diagram 790 of an extension device applied to the ankle joint according to one embodiment, showing the ankle in a state of maximum extension. [Figure 31B] Figure 31B is a sagittal plane schematic diagram of the extension device shown in Figure 31A, illustrating the state in which the ankle is flexed to its limit. [Figure 32] Figure 32 is a schematic diagram 810 of one embodiment, which has the same function as a multifaceted nerve regulation stretching device. [Figure 33] Figure 33 is a schematic diagram of a collaborative robot (cobot) according to one embodiment. [Figure 34A] Figure 34A is a horizontal schematic diagram 860 showing a user undergoing a static joint test using a cobot-based neural control device according to one embodiment. [Figure 34B] Figure 34B is a schematic diagram in a roughly sagittal direction showing a user undergoing the static joint test shown in Figure 34A, according to one embodiment. [Figure 35A] Figure 35A is a schematic diagram 890 showing the subjective viewpoint of the augmented reality neural control visualization device, and shows a magnified view of the user's hand, holding the position assist device, tracing the first curve at the first time point. It also shows the hand's path at past time points (time points prior to the first time point). [Figure 35B] Figure 35B is a schematic diagram 910 showing the subjective viewpoint of the augmented reality neural control visualization device, and shows a magnified view of the user's hand, holding the position assist device, tracing the first curve at the second time point. It also shows the hand's path at past time points (time points prior to the second time point). [Figure 35C]Figure 35C is a schematic diagram 920 showing the subjective viewpoint of the augmented reality neural control visualization device, and shows a magnified view of the user's hand, holding the position assist device, tracing the first curve at the third time point. It also shows the hand's path at past time points (time points prior to the third time point). [Figure 35D] Figure 35D is a schematic diagram 930 showing the subjective viewpoint of an augmented reality neural control visualization device, and shows a magnified view of the user's hand holding the position assist device and the sinusoidal path with its central portion occluded, as shown in Figure 17A. [Figure 36A] Figure 36A is a schematic diagram 950 showing the subjective viewpoint of the augmented reality neural control visualization device, and shows a magnified view of the user's hand, holding the position assist device, tracing the first curve at the first time point. The hand's path at past time points (times before the first time point) and future time points (times after the first time point) are also shown. [Figure 36B] Figure 36B is a schematic diagram 960 showing the subjective viewpoint of the augmented reality neural control visualization device, and shows a magnified view of the user's hand, holding the position assist device, tracing the first curve at the second time point. It also shows the hand's path at past time points (before the second time point) and future time points (after the second time point). Note that the user's hand is obscured in Figure 36B. [Figure 36C] Figure 36C is a schematic diagram 970 showing the subjective viewpoint of the augmented reality neural control visualization device, and shows a magnified view of the user's hand, holding the position assist device, tracing the first curve at the third time point. The hand's paths at past time points (before the third time point) and future time points (after the third time point) are also shown. [Figure 36D] Figure 36D is a schematic diagram showing the subjective viewpoint of the augmented reality neural control visualization device, and is an enlarged view of the sinusoidal path shown in Figure 17A, with the central portion obscured. Note that in Figure 36D, the display of the user's hands is obscured. [Figure 37] Figure 37 is a schematic diagram showing the postoperative condition of total knee arthroplasty according to one embodiment. [Figure 38]Figure 38 is a schematic diagram 1020 of a body-worn digital goniometer according to one embodiment. [Figure 39] Figure 39 is a schematic diagram 1040 of an exoskeleton-type device configured as a neuromuscular therapy device (NMT device) according to one embodiment. [Figure 40] Figure 40 is a schematic diagram 1060 of the push-pull motion cycle required to pedal a bicycle, viewed from the perspective of one leg, according to one embodiment. [Figure 41] Figure 41 is a schematic diagram 1100 of data delivered from a pedal connected to a nerve control device according to one embodiment. [Figure 42] Figure 42 is a schematic diagram 1130 of the maximum capacity calibration data obtained according to one embodiment. [Figure 43A] Figure 43A is a schematic diagram 1130 of the user display during a training session of a single-leg neuromodulatory training program according to one embodiment. [Figure 43B] Figure 43B is a schematic diagram 1150 of the user display during a training session of a bilateral nerve modulation training program according to one embodiment. [Figure 43C] Figure 43C is a schematic diagram 1160 of the user display during a training session of a bilateral leg neuromodulatory training program that focuses solely on the bilateral leg pushing movement cycle, according to one embodiment. [Figure 44] Figure 44 is a schematic diagram of an exemplary user display during the execution of a neuromodulatory training program configured to optimize the capabilities of a series of muscles, according to one embodiment. [Figure 45] Figure 45 is a schematic diagram of mirror therapy according to one embodiment. [Figure 46] Figure 46 is a schematic diagram 1220 of a neuromodulatory device that combines the features of mirror therapy and a virtual reality or augmented reality headset according to one embodiment. [Figure 47] Figure 47 is a schematic diagram of whole-body neuromodulation using a virtual reality or augmented reality headset according to one embodiment. [Figure 48] Figure 48 plots the percentage of time in which the error falls within three error bands in eight trials constituting a single neuromodulatory therapy session for a patient using a neuromodulator according to one embodiment. [Figure 49A] Figure 49A is a schematic diagram of a device used for evaluating balance function and for neuromodulatory therapy to improve balance function. The evaluation of balance function is shown only in the sagittal plane. [Figure 49B] Figure 49B is a schematic diagram of a device used for evaluating balance function and for neuromodulatory therapy to improve balance function. [Figure 50] Figure 50 is a plot of the anterior-posterior components of a predetermined pattern used for evaluating balance function and for neuromodulatory therapy to improve balance function. [Figure 51] Figure 51 is a schematic diagram of a series of Lissajous figures. [Figure 52A] Figure 52A is a schematic diagram of a predetermined circular oscillation pattern used for evaluating balance function and for neuromodulatory therapy to improve balance function. [Figure 52B] Figure 52B is a schematic diagram of the anterior-posterior component of a predetermined circular oscillation pattern used for evaluating balance function and for neuromodulatory therapy to improve balance function. [Figure 52C] Figure 52C is a schematic diagram of the left-right component of a predetermined circular oscillation pattern used for evaluating balance function and for neuromodulatory therapy to improve balance function. [Figure 53A] Figure 53A is a schematic diagram of a predetermined circular oscillation pattern used for evaluating balance function and for neuromodulatory therapy to improve balance function, along with real-time measurement results of the user's posture. [Figure 53B] Figure 53B is a schematic diagram showing the anterior-posterior and lateral orthogonal components of a predetermined circular oscillation pattern used for evaluating balance function and for neuromodulatory therapy to improve balance function, along with real-time measurement results of the user's posture. [Figure 54A]Figure 54A is a schematic diagram of a predetermined circular oscillating pattern with a central portion occluded, used for evaluating balance function and for real-time feedforward motor learning in neuromodulatory therapy to improve balance function. [Figure 54B] Figure 54B is a schematic diagram of the anterior-posterior component of a predetermined circular oscillating pattern, with its central portion occluded, used for evaluating balance function and for real-time feedforward motor learning in neuromodulatory therapy to improve balance function. [Figure 54C] Figure 54C is a schematic diagram of the left-right component of a predetermined circular oscillating pattern, with its central portion occluded, used for evaluating balance function and for real-time feedforward motor learning in neuromodulatory therapy to improve balance function. [Figure 55] Figure 55 is a schematic diagram of a predetermined circular oscillating pattern with a centrally occluded portion, used for evaluating balance function and for real-time feedforward motor learning in neuromodulatory therapy to improve balance function, along with real-time measurement results of the user's posture.

[0084] In the following description, similar reference numerals indicate similar or corresponding parts throughout the drawings. [Modes for carrying out the invention]

[0085] The following describes embodiments of methods, systems, and devices for performing neuromodulation therapy, as well as evaluations of neuromuscular control of musculoskeletal joints, with reference to the drawings. For convenience, neuromodulation therapy, abbreviated as NMT, covers a wide range of applications. This includes the treatment of diseases such as arthrogenic muscle inhibition (AMI), rehabilitation therapy, and, in cases of injury, the use of NMT to restore damaged joints and neuromuscular systems to their original state and functional level, or at least improve the injured state even if complete functional recovery is impossible. For example, NMT is used to aid recovery from surgical treatments and related therapies such as total knee arthroplasty (TKA), cartilage repair, cymbal injection (intra-articular injection of synthetic viscous fluid), and cortisone injection. NMT also broadly includes therapies aimed at achieving a higher functional state than before treatment. This is broader than rehabilitation and may be performed not only by patients (users) to manage their own condition, but also by those aiming for the development and improvement of their abilities. For example, children with cerebral palsy may use NMT to manage their own condition, although this is not strictly classified as rehabilitation. Furthermore, children and amateur athletes can use the embodiments of NMT described herein to accelerate the development of motor skills and provide a more precise, rapid, and superior method for reaching desired abilities. Therefore, applications in ability development include ability optimization and ability enhancement. For example, elite athletes can use embodiments of NMT to perform highly relevant targeted motor skills training to fine-tune neuromuscular control of specific joints or neuromuscular systems, increasing the probability of achieving accuracy in outcome-based tasks (i.e., achieving optimal ability). Thus, it will be understood that the methods of providing NMT described herein, and the associated systems and apparatus, are applicable to a wide range of uses, including rehabilitation, ability development, and ability optimization. In the following description, the term NMT should be understood to broadly refer to any of these applications.

[0086] Embodiments of the NMT of the present invention broadly involve performing a series of feedforward movements (i.e., actions) in relation to at least one target musculoskeletal joint or muscle groups involved in the sensorimotor system during the performance of the movement. The series of movements includes feedback movements, and the ratio and order of feedback movements to feedforward movements may be changed during the treatment process. The movements may target a single musculoskeletal joint or multiple musculoskeletal joints, such as the shoulder, knee, and hip joints. The user is instructed to perform the movements along with instructions to perform an ability such as attempting to match one or more target parameters. One or more target parameters are presented and measured while the user is performing the movements. In feedback movements, the target parameters are presented to the user during the performance of the movements. In contrast, in feedforward movements, the presentation is suppressed (muted, silenced) for at least a portion of the movement. The form of presentation of the target parameters may be visual, auditory, tactile, other presentations, or a combination thereof. Instructions to the user may be visual, auditory, tactile instructions, or a combination thereof, and may be explicitly instructed to match the target parameters. Suppression refers to a period of one or more times during which the target parameter is not presented to the user. These suppression periods represent a temporal gap in the presentation of the target parameter. During the suppression period, the target parameter has a known value, and the user attempts to match it. However, because the target is not presented, the user must actively estimate how to perform the movement during the suppression period. In some embodiments, suppression creates a gap in the presentation of the target parameter, so feedforward refers to the need for the user to estimate the amount of control of the target musculoskeletal joint during the suppression period in order to match the target parameter at the end of the suppression period (forward time). Feedforward is also used as a contrasting term to feedback, where the user is provided with presentation for the entire presentation period. Movement can consist of one or more actions, such as static actions like holding a joint in a specific position or angle, applying a constant force, or maintaining a stationary state; dynamic actions like moving a joint within its range of motion; or a series of actions including repetitive (periodic) movements. "Action" and "movement" are used as synonyms.In other words, a reference to performing an exercise is equivalent to performing one or more actions (similarly, one or more exercises are equivalent to performing one or more actions). Instructions are provided before the start of the exercise and, if necessary, during the exercise. For example, if the exercise consists of a series of actions, these may include the next action, or the timing at which the target parameter should be matched during the exercise. The user may be instructed to perform the exercise on an instrument equipped with measuring devices configured to measure the target parameter. Alternatively, the user may use a system that includes one or more sensors configured to measure the target parameter while performing the exercise. As described above, the user may be provided with presentations of one or more target parameters while performing the exercise. Feedback presentations may also be provided during or at the end of the exercise. Feedback presentations are based on measurements of the target parameter captured during the exercise (i.e., during the capture period). The capture period can be the entire duration of the exercise (i.e., continuous sampling of measurements during the exercise) or a portion thereof. The capture period includes at least a period during which presentations are suppressed in feedforward exercises. The capture period may be the same as or different from the presentation period. For example, if the target parameter is force, force may be continuously sampled during the capture period to generate time-series measurements of force. Feedback may be provided as a measurement or summary value (i.e., without calculating the difference between the target parameter and the measured parameter), or as a parameter or summary value derived from the measurement (including those based on the difference between the measured parameter and the target parameter). In one embodiment, a user is instructed to perform a movement by a device such as a collaborative robot, and the device is further configured to measure target parameters while the user is performing the movement. The user is also provided with instructions on how to perform the movement, such as resisting the instructed movement, following a predetermined action, or matching the target parameter, and as described above, the user may be provided with a presentation of target parameters during the movement.

[0087] Neuromuscular assessment of the neuromuscular control of a target musculoskeletal joint can be performed as part of neuromodulatory therapy or as a standalone assessment. During the assessment, the method further includes a step to determine how accurately the user is performing the exercise, for example, by calculating the difference between the target value and the measured value of a target parameter (or multiple target parameters). This accuracy may be reported to the user and / or clinician. In the case of a standalone assessment, the exercise may consist of feedback exercises only, feedforward exercises only, or a combination of feedback and feedforward exercises. When performed as part of neuromodulatory therapy, the assessment may be performed to determine baseline measurements and / or to assess the progress of neuromodulatory therapy.

[0088] Neuromuscular assessments are used to determine when to initiate the progression of treatment, such as introducing feedforward movements, or when to initiate the progression of inhibition, such as increasing (or decreasing) the complexity of the movement. Triggers for change include altering the phase, duration, or complexity of inhibition of presentation by changing the percentage of presentation time during which the presentation is inhibited during feedforward movements. Triggers for progression may be automated or used by clinicians to determine progression. In one embodiment, the NMT assessment is a measure of smoothness of movement, error summary, and control summary obtained using the difference (or deviation) between a target parameter and a measured parameter over the entire duration of a movement or series of movements, and is used to determine progression. This is done by analyzing the distribution of the difference (deviation or error) between the target parameter and the measured parameter, such as by comparing it to a predetermined threshold or range, or by performing a temporal, spectral, or statistical analysis of that distribution. In one embodiment, the assessment includes determining one or more accuracy measures using the difference, which are compared to one or more predetermined trigger thresholds and used to determine when to initiate a change in inhibition (i.e., a change in the percentage of presentation time during which the presentation is inhibited). The difference can be compared to a predetermined difference threshold and used to define the difference range. The accuracy measure may be an estimate of the proportion of time during each motion in which the difference falls within a difference range of 1 or more.

[0089] In one embodiment, one or more presentation periods and one or more capture periods are both the duration of the exercise, and the force is repeatedly measured (i.e., sampled) by the device during the duration of the exercise. Subsequently, the difference between the target force and the measured force is calculated at each measurement (or sampling) point. That is, the time-series force measurements are converted into a time-series of differences. These differences can be normalized or converted into a percentage error (% error difference): % error difference = 100% × [target value - measured value] / target value. Then, each percentage error is compared to a difference threshold (e.g., 5%, 10%) to calculate the accuracy measure, which is the percentage of time during the exercise when the percentage error was below the difference threshold or within the difference range. This accuracy measure is compared to a trigger threshold (e.g., 90%) to determine whether to trigger a change, such as a complexity progression. For example, if the difference was less than 10% for at least 90% of the exercise duration (difference threshold 10%, trigger threshold 90%), the complexity progression is automatically triggered. Evaluation is also performed to determine when to reduce the complexity. For example, a second trigger threshold is used to indicate a decrease in accuracy. For instance, a decrease in complexity is triggered if the difference is less than 10% for at least 50% of the motion time (difference threshold 10%, second trigger threshold 50%). To be clear, accuracy measurements can be compared to both the first trigger threshold (trigger for increased complexity) and the second trigger threshold (trigger for decreased complexity). These can be programmed into the NMT device's control unit, in which case the trigger thresholds automatically trigger changes in presentation inhibition in subsequent motions.

[0090] More complex or multifactorial evaluations of the difference may be used to measure the smoothness of movement (or motion), or to generate error summaries or control summaries (i.e., the range of target parameters and / or ranges of one or more joint angles in which the user has insufficient control of the target musculoskeletal joint). One or more of these can be reported electronically and / or used to trigger the progression of inhibition. For example, multiple thresholds and / or difference ranges (green / good = difference < 4.25%, orange / medium = 4.25-7.5%, red / poor ≥ 7.5%) can be defined, and the time percentage in each error range can be determined. Thus, instead of simply determining the time percentage in which the error difference is in the green / good range and using this to evaluate smoothness or trigger progression, more complex trigger conditions can be used that take into account the time percentage in the orange / medium and / or red / poor ranges. In yet another embodiment, absolute deviation may be used instead of percentages in the evaluation. Alternatively, smoothness can be evaluated by performing time analysis, spectral analysis, statistical analysis, analysis of the first and second derivatives of the difference, outlier analysis, etc.

[0091] To aid in understanding the embodiments of NMT (and neuromuscular assessment), we will first focus on its application in rehabilitation. Many rehabilitation programs aim to strengthen or restore muscles, but they are often overgeneralized and fail to accurately measure or improve joint control. In some cases, they even target the wrong muscles or movements. Loss of control is often limited to specific force range, timing, coordination, or specific movements or joint angles. This loss of control is not adequately assessed by conventional methods and systems, and because rehabilitation programs do not address the root cause of joint control loss, patient recovery is either incomplete or stalls before reaching optimal musculoskeletal control capacity. In contrast, the embodiments described herein aim to promote patient recovery by evaluating and quantifying neuromuscular control, enabling the development of more effective treatment and rehabilitation programs.

[0092] Traditional rehabilitation methods fail to consider the significant changes in the afferent signaling environment after injury or surgery. For example, surgery itself causes trauma to the skin, joint capsule, graft site, blood vessels, nerves, and bone as a result of incision, suturing, perforation, debridement, and excision. These interventions immediately and permanently alter the morphology and biomechanics of the joint. For instance, in anterior cruciate ligament (ACL) reconstruction surgery, achieving precise surgical placement of autologous tendon grafts is rare. Similarly, total knee arthroplasty can result in permanent changes in lower limb length. These preoperative changes in joint alignment and biomechanics usually affect not only the joint itself but also other parts of the body, requiring rapid adaptation to the postoperative state. These changes, in particular, present significant challenges for the central nervous system in terms of immediate adaptation.

[0093] Therefore, the present invention proposes a neuromuscular assessment method that focuses on identifying parameter ranges in which a patient has insufficient control over target musculoskeletal joints. The parameters obtained by this assessment method can also be used as target parameters when the patient performs feedback and feedforward movements related to the target parameters in a rehabilitation program based on neuromuscular motor training (NMT). This encourages attention to areas where the patient has insufficient control and to new afferent signal environments after injury, leading to improved rehabilitation outcomes. This embodiment is also applicable to the treatment of arthrogenic muscle inhibition (AMI). AMI is a major cause of muscle weakness, muscle atrophy, and poor motor control in rehabilitation after trauma or surgery, as well as in aging and sedentary populations. Inhibition in AMI is thought to be caused by a mismatch between the state of afferent information that the brain expects, formed from past experiences, and the current state of afferent information. The motor cortex of the brain is wired by afferent information accumulated over many years, which forms the reference afferent information. When trauma or joint injury (including surgical intervention) occurs suddenly, the afferent information from the new or altered joint no longer matches the brain's model of how the joint should respond to afferent signals or commands. As a result, the brain inhibits movement because the feedback from the joint contradicts the expected movement (i.e., the baseline afferent information). Studies on changes in brain activity using functional magnetic resonance imaging (fMRI) have shown that subjects with a history of injury activate frontal cortical regions responsible for motor planning and neurocognition more strongly. Physiologically, these frontal cortical regions are directly connected to the cortical regions responsible for motor commands (motor cortex) and can influence descending motor output. The increased frontal cortical activity is thought to reflect the need for higher neurocognitive attention and processing during muscle contraction. This likely occurs as compensation for the loss of reliable sensory input from the injured joint; that is, the brain is likely forced to rely on other sensory information, such as visual or cerebellar input, to modulate motor function.

[0094] Therefore, AMI is likely not purely due to reflexes, as is commonly believed, but rather to unfavorable neuroplastic adaptations to a changed sensory environment. That is, these chronic changes in afferent signal transmission from the injured joint further promote cortical / nervous system reorganization, resulting in a neural environment unfavorable to optimal muscle contraction, which manifests as AMI. Rehabilitation can be aided by embodiments of the NMT method described herein. These embodiments focus on the assessment of musculoskeletal control and the performance of repetitive movements, designed to restore control and function by accelerating the retraining of the neuroplastic brain and adapting to the new signal environment. Furthermore, the same rehabilitation programs used in AMI treatment can also be used to monitor and treat the progression of neurodegenerative diseases and mild cognitive impairment, and to support the development and improvement of abilities in athletes and other (highly skilled) individuals. These diverse embodiments are collectively referred to as Neuromodulation Therapy (NMT), and devices for providing NMT are referred to as NMT devices.

[0095] To further aid in understanding the embodiments of this disclosure, it is useful to first describe in detail the musculoskeletal structure of the human body and the neuromuscular control mechanisms by which the nervous system and brain control bodily movements. For the sake of simplification of the discussion, it is appropriate to define the main planes of motion based on a conceptual representation of the human body. Figure 1 is a schematic diagram showing three orthogonal planes used in medical imaging. The cross-sectional or axial plane 12, sagittal plane 14, and coronal plane 16 are used throughout this specification to simplify the description of embodiments.

[0096] The control of musculoskeletal joints typically involves coordination between the nervous and musculoskeletal systems. The degree of musculoskeletal control is characterized by applying the appropriate force to the appropriate movement at the appropriate time at each of multiple joint angles. Impairment or reduction of normal function can be caused by many factors, including injury, surgery, aging, and diseases affecting the neuromuscular system. These impairments manifest as a variety of clinical symptoms, including loss of control of one or more musculoskeletal joints. Loss of control is often limited to a specific range of force or joint angle. While this embodiment discloses a musculoskeletal joint of interest, in clinical practice patients may have other problems affecting joints, ligaments, tendons, muscles, muscle groups, or other issues that affect loss of control of a particular musculoskeletal joint, and the treatment of all such problems is considered within the scope of this disclosure. Smooth and controlled movement requires the coordination of many muscle groups across multiple joints, and much of this specification refers to a specific joint (the joint of interest) in isolation, which simplifies the discussion and allows it to serve as a reference point for a larger system. Therefore, the embodiments described herein are applicable not only to the rehabilitation and improvement of movement of a single joint, but also to related joint groups such as the entire limb, and even to the improvement of movement of the whole body. In other words, the embodiments described herein should be understood to relate to methods, apparatus, and systems for muscle coordination at all levels.

[0097] Loss of control of a specific body part is characterized by an inability to exert the necessary control within a defined range of motion specific to that part. Loss of control can be caused by a variety of factors. It may be due to localized damage, such as the loss of sensory or functional cells. It may also be due to loss of neuromuscular control, resulting from the brain sending inappropriate compensatory signals in response to the injury, or from the brain and / or central nervous system sending inappropriate signals to the targeted functional musculoskeletal group or adjacent functional group. In the latter case, loss of control is a state in which the brain continues to perform inappropriate learned behaviors, which can be compensated for by appropriate retraining. In the context of this specification, loss of control is understood to include all loss of control, including but not limited to loss of neuromuscular control.

[0098] The embodiments of the method for evaluating neuromuscular control are not limited to those described herein, but are applicable to a wide range of body parts and joints, including the shoulder, elbow, fingers, hip, knee, and back, where the force exerted by the relevant muscles and / or range of motion can be measured over a period of time. The embodiments are applicable to any musculoskeletal structure or group of structures within the body, but the example structure selected in the initial description is the knee joint. However, it should be understood that this is merely to facilitate understanding of the embodiments of various methods, devices, and systems for evaluating neuromuscular control and developing and implementing rehabilitation programs. In other words, the described embodiments can be adapted, modified, and extended to other joints other than the knee joint. Thus, Figure 2A is a schematic diagram showing a coronal section of the main skeletal structure of the human leg. The knee joint 22 connects the proximal 24 and distal 26. The proximal 24 (femur) is connected to the body 28 via the hip joint 30, and the distal 26 (composed of the tibia and fibula) terminates at the ankle joint 32. For clarity, a simplified diagram of the foot bones is shown by reference numeral 34. Figure 2B is a schematic diagram 40 showing a sagittal section of the main muscle groups of the human leg, with elements similar to those in the previous diagrams being denoted by the same symbols. The quadriceps femoris muscles 42, located on the anterior aspect of the femur 24, and the hamstring muscles 44, located on the posterior aspect of the femur 24, work antagonistically to each other to control the elevation of the femur 24 in the sagittal plane. Other smaller muscle groups, not shown, control the lateral movement of the femur. The gastrocnemius muscles 46, located on the posterior aspect of the tibia, control the position of the lower leg, i.e., the angle between the tibia and femur in the sagittal plane. Other soft tissues are not shown, but it is understood that smaller muscles, ligaments, tendons, nerves, and other soft tissues are present in the human leg for the proper function of each joint.

[0099] In this specification, musculoskeletal control can be defined as the ability to apply appropriate force to a given joint in the appropriate timing for the appropriate movement. Appropriate function is considered to be the ability to maintain smooth movement of the joint through the required angular range within a given time under varying loads. Conversely, it can also be defined as the ability to exert the required force under relevant conditions. Therefore, the degree of control is characterized by the ability to perform a task with the joint in question at a given angle and under a defined force load.

[0100] The normal function of joints and muscle groups can be impaired by trauma or surgical intervention for certain diseases. Taking the knee joint as an example, a typical sports injury is an anterior cruciate ligament rupture, which is often surgically reconstructed. Similarly, total knee arthroplasty is a common procedure, with millions of surgeries performed annually. In both cases, rehabilitation programs include exercises to strengthen the surrounding muscles, typically involving resistance training. Taking the knee joint as an example, resistance training includes exercises known as squats. In the early stages of recovery, since it may not be possible to lift one's own body weight, lighter or assisted exercises are appropriate. This includes the use of Pilates Wanda Chair or Pilates Reformer, which generate resistance with springs that increase resistance as extension progresses. Alternatively, it may include the use of a leg press machine, where one lifts their own body weight along an inclined ramp, or gym equipment that lifts a set of adjustable weights via non-stretchable cables and pulley systems. In all these rehabilitation exercises, a method is used that gradually increases resistance as the strength of the muscles surrounding the joint recovers, with the goal of reaching the maximum possible muscle strength. Unfortunately, arthrogenic muscle inhibition remains a difficult-to-resolve limiting factor in all rehabilitation programs. In AMI, the presence of an inhibited motor neuron pool reduces the number of fully functional motor units available to activate muscles and generate force. This reduction in available functional motor units also leads to the early onset of fatigue, as the same healthy motor units are repeatedly recruited during repetitive movements. Clinically, this manifests as muscle weakness, muscle atrophy, and poor motor control lacking the neuromuscular adaptations expected in a healthy, untrained state.

[0101] Figure 3A is a schematic diagram 60 of a normal, healthy motor neuron pool in an excited state. The motor neuron sheath 62 holds the motor neuron bundle, which contains the majority of actively recruited motor units 64 and a small number of healthy reserve motor units 66. The motor neuron bundle 60 is in a state of maximum force, with almost all motor units active. A very small number of motor units are considered to be in a reserve state, but this does not mean they are not capable of malfunctioning. Under normal conditions, even when considered to be in a state of maximum force, not all motor units are recruited. This is how the body protects itself from everyday overexertion. In extreme situations, the presence of high levels of adrenaline can recruit these reserve motor units into activity, which corresponds to situations where a person is reported to exhibit superhuman strength, such as when a loved one is pinned under a heavy object.

[0102] Figure 3B is a schematic diagram 70 of the action potentials of the resulting voluntary muscle force generated by the motor neuron bundle 60. The action potentials 72 of the force generated by the voluntary muscle are shown as a function of time from the start of the motor event 74 to the end of the maximal motor event 76. The action potential of the maximum possible resulting voluntary muscle force output is represented by intensity 78, but under normal maximal effort, this maximum value is not achievable at any point due to the small number of reserve motor units. In a normal, healthy motor neuron pool (see schematic diagram 60 in Figure 3A), it can be seen that the action potentials 72 increase as motor units are activated, and the action potential of the maximal voluntary muscle force output is relatively consistent throughout the motor event.

[0103] For comparison, Figure 4A is a schematic diagram 80 of the motor neuron pool where arthrogenic muscle inhibition occurs in an excited state, with the same symbols used for elements similar to those in the previous diagram. At maximum output, there are few actively recruited motor units 64, and similarly few reserve motor units 66. However, in contrast to the 60 healthy motor neurons, the arthrogenic muscle-inhibited motor neuron pool contains a large number of inhibited motor units 82. The ratio of inhibited motor units 82 to active motor units 64 determines the degree of reduction in maximum spontaneous output. Similarly, Figure 4B is a schematic diagram 90 of the resulting voluntary muscle output in a motor neuron bundle where arthrogenic muscle inhibition occurs. The resulting voluntary muscle output 92 shows a significant decrease in the maximum possible force, as expected from the reduction in the number of normally functioning active motor units. The maximum value of voluntary muscle output 92 throughout the entire motor event is also shown to be highly irregular. This indicates the temporal variability of maximum muscle force during the motor event, which is consistent with typical physiological findings of AMI. Arthrogenic muscle inhibition is therefore a major cause of muscle weakness, muscle atrophy, loss of control over stable force output, and poor motor control in rehabilitation from trauma and surgical interventions, as well as in aging and sedentary populations.

[0104] Despite the goal of rehabilitation being the recovery of quadriceps muscle strength and function, many patients exhibit persistent quadriceps dysfunction for months to years after surgery. Incomplete voluntary activation refers to a state in which the quadriceps muscle cannot be fully and sufficiently activated during contraction, and is considered one of the common causes of quadriceps weakness after anterior cruciate ligament (ACL) reconstruction. Incomplete voluntary activation can result from insufficient recruitment of motor units within the quadriceps muscle, and / or suboptimal firing of recruited motor units (known as rate coding). This persistent quadriceps weakness is associated with abnormalities in knee biomechanics, increased joint contact force, simultaneous activation of the quadriceps and hamstrings, patient-reported functional decline, and decreased functional capacity in patients who have undergone ACL reconstruction. Curiously, quadriceps weakness is not limited to the leg that has undergone ACL reconstruction (or total knee arthroplasty). As frequently reported in the literature, bilateral quadriceps muscle weakness and impaired voluntary activation are commonly observed in patients undergoing ACL reconstruction. This suggests a neurological bilateral inhibitory process rather than a localized problem within the injured, reconstructed, or surgically altered joint.

[0105] Reduced spontaneous activation has been extensively reported in the literature in both the reconstructed and unreconstructed legs compared to the healthy control leg (i.e., the leg of a non-injured control group subject), and this bilateral inhibition has been thought to be due to bilateral muscle weakness observed after unilateral ACL injury and reconstruction. Recent findings suggest the contribution of neurological changes occurring after ACL reconstruction. For example, changes in spinal reflexes and corticospinal tract excitability have been reported after ACL injury and reconstruction, and these changes are associated with quadriceps muscle weakness after ACL reconstruction. Spinal reflex excitability is usually measured using the quadriceps Hoffman reflex (H reflex), which is an indicator that estimates the proportion of the motor neuron pool that can be voluntarily activated. The H reflex is influenced by both presynaptic and postsynaptic pathways, and reduced H reflex excitability is thought to be a contributing factor to poor voluntary activation of the quadriceps femoris after ACL injury or surgery. Neurophysiological changes associated with the loss of mechanoreceptors in the ACL after injury and surgery appear to affect the excitability of the corticospinal tract. As a result, damage to the corticospinal tract may suppress nerve activity to the quadriceps femoris muscle, potentially inducing muscle weakness and impaired activation.

[0106] Despite evidence of arthrogenic muscle inhibition and injury, postoperative muscle weakness, and neuromuscular factors driving uncontrolled movement, conventional treatment protocols focus almost entirely on muscle strengthening. Squats and leg raises are frequently prescribed in rehabilitation programs during the recovery phase of anterior cruciate ligament injury and after total knee arthroplasty. As an indicator of recovery, it is often required to keep the muscle strength difference between the injured and uninjured knees within 5%. This is problematic for several reasons, particularly bilateral inhibition and muscle weakness.

[0107] To advance the discussion on neuromuscular control of the knee joint, it is beneficial to highlight the major muscle groups that drive the biomechanics of the knee. Figure 5A is a simplified sagittal schematic diagram 100 of the musculoskeletal system of the human leg, showing the quadriceps femoris 42 and hamstrings 44 in a resting state. Elements similar to those in previous drawings are denoted by the same reference numerals. The quadriceps femoris 42 is connected to the hip joint (not shown) via tendon 102 and to the tibia 26 via tendon 104. The hamstrings 44 are connected to the hip joint via tendon 106 and to the tibia 26 via tendon 108. Figure 5B is a simplified sagittal schematic diagram 110 of the human lower limb musculoskeletal system during a leg elevation movement 112, with elements similar to those in previous drawings being denoted by the same reference numerals. During the leg elevation movement 112, the quadriceps femoris 42' is considered the prime mover and contracts 114 to initiate this movement. On the other hand, the hamstrings 44' are antagonistic muscles and stretch 116 during the inhibitory process. This type of lower leg elevation movement is similar to a squat, especially when the movement is inhibited by springs 118, weight, or other resistance. Conversely, when lowering the leg against some resistance (not shown in Figure 5B, but such as gym equipment), the hamstrings 44 act as the prime mover, and the quadriceps femoris 42 act as the antagonist. This process is a mirror image of the previously described process when lifting the lower leg. The nervous system causes the hamstrings 44 to contract while the quadriceps femoris is mutually inhibited and stretched.

[0108] Neuromuscular control has two main aspects, both of which are involved in the decline in motor control accuracy after injury or surgical intervention: the corticospinal tract in the central nervous system and the spinal reflex pathways in the peripheral nervous system. The corticospinal tract can be considered the main trunk road for information traveling up and down the spine, while the spinal reflex pathways are like side roads that transmit information from the spine to the periphery of the nervous system and from the periphery to the spine.

[0109] The planning, control, and execution of voluntary movement originate in the motor cortex, a region of the frontal lobe of the cerebral cortex. These "command" signals, originating in the cerebral cortex, travel along superior motor neurons, passing through the thalamus, midbrain, pons, and medulla oblongata before entering the spinal cord. The superior motor neurons travel through the corticospinal tract within the spinal column, and upon reaching the relevant vertebrae, they prepare to exit the spinal cord, where they synapse with a second neuron in the anterior horn of the spinal cord. This second neuron is the inferior motor neuron, which exits the spinal cord and ultimately synapses with the motor unit of the target skeletal muscle.

[0110] The "command" signal is only one part of the neuromuscular control system. A specific motor trajectory is monitored in real time against the target or commanded movement. The error correction feedback system fine-tunes the motor trajectory via a secondary motor control system. There are two feedback pathways that influence trajectory error correction: the corticospinal tract and spinal reflexes. The corticospinal feedback system is primarily regulated by the cerebellum. The cerebellum is the major structure in the hindbrain of all vertebrates and plays a crucial role, especially in voluntary motor control. While it may also be involved in cognitive functions such as attention and language, and emotional control such as the regulation of fear and pleasure responses, its motor-related functions are the most widely established. The human cerebellum does not initiate movement, but contributes to coordination, precision, and accurate timing. The cerebellum itself receives input from the sensory system of the spinal cord and other parts of the brain, integrating these to regulate and fine-tune motor activity. To put this into practice, afferent input to the cerebellum can reach 40 times its output, demonstrating its scale in organizing and regulating a large amount of sensory information into coordinated voluntary motor output. The motor function of the cerebellum can be likened to that of an orchestra conductor. For example, it plays a role in coordinating the performance of brass, woodwind, string, and percussion players to ensure they play in harmony. Without the cerebellum, motor function would be disrupted, resulting in irregular, ataxic movements.

[0111] In addition to its direct role in voluntary movement control, the cerebellum is essential for several motor learning processes, particularly adaptive learning to changes in sensorimotor relationships. Structurally, the cerebellum contains only a few major cell types and structures and is organized into a distinct layered structure. Figure 6 is a schematic diagram of the signal processing structure of the cerebellum. Purkinje cells are unique neurons specific to the cerebellar cortex. They are easily identifiable, possessing a large, intricately branched, flattened dendritic tree and exhibiting the ability to learn by integrating large amounts of information and reconstructing dendrites. In the three-layered cerebellar cortex, the cell bodies of Purkinje cells constitute the middle layer, while the dendritic tree forms the outermost layer. Purkinje cells play a major role in the motor coordination of cerebellar circuits, providing fine-tuning and trajectory corrections to ongoing movements.

[0112] Purkinje cells are arranged in a flat, sheet-like structure perpendicular to the folds of the cerebellum, through which orthogonal "parallel fibers" 126 transmit information 128 aggregated by granule cells 130 deep within the cerebellum. Granule cells 130 receive information from multiple mossy fibers 132, and their axons 134 branch into a network of parallel fibers 126. Climbing fibers 136 transmit afferent information about the actual movement of the body, forming synapses 138 with basket cells 140 as they ascend the cerebellum, then wrapping themselves around the dendritic tree 124 (indicated 142), forming multiple synapses as they climb the dendrites. Basket cells 140 form synaptic connections with multiple Purkinje cells 144 and with parts of the parallel fiber network (not shown for simplification). Information 146 about the required / predicted movement of body parts received from mossy fibers is transmitted via numerous parallel fibers and multiplexed throughout the dendritic tree of Parkinge cells. Each parallel fiber forms hundreds to thousands of synaptic connections as it passes through the dendritic layer. This resembles a large-scale exchange-like matrix structure, enabling highly parallel processing. Climbing fibers 136 and their associated basket cells 140 transmit information 148 and 150, respectively, which is obtained from the vestibular system (providing information on movement, head position, and spatial orientation), the reticular formation (a complex network of brainstem neurons that functions as a major integration and relay center), the superior colliculus (responsible for the integration of environmental stimuli and the coordination of eye and head movements related to gaze), and several other sensory systems. Predictive motor information 146 is compared with actual motor information 148 and 150, resulting in inhibitory signals 152 being sent to both Purkinje cells and the synaptic connections (not shown for simplification) between the parallel fibers and the dendrites themselves. As a result, the drive signals 154 to the motor system are suppressed, and the trajectory of movement is corrected. The full output of Purkinje cells is then sent to the ventrolateral thalamic nucleus via the deep cerebellar nuclei (not shown for simplicity), where it is expected to be fed back into the ongoing movement of the motor cortex, smoothly correcting motor errors.

[0113] The vast dendritic tree of Purkinje cells is considered essential to this trajectory correction process. These receive complex inputs from a vast array of parallel fibers, which the Purkinje cells then integrate into a single representation of "how the current movement should be." This is compared to the actual movement derived from afferent signals transmitted via climbing fibers to parallel fiber-Purkinje cell synapses and via basket cells to the Purkinje cells themselves. Error correction signals receive this and correct the efferent drive. Each Purkinje cell receives input from up to 200,000 parallel fibers and indirectly receives information from over 1 million mossy fibers. This vast array of parallel fibers integrates motor signals from the arms, legs, trunk, and head to produce meaningful voluntary movement. The cerebellum functions as a signal processing system that aggregates commands from the entire central nervous system and corrects motor trajectories by inhibiting activating or antagonistic muscle groups as needed.

[0114] The brain as a whole exhibits extremely high neural plasticity at birth. In many vertebrates, nerve cells undergo extensive rewiring during postnatal development, removing synapses from the initial overconnected network. This process, called "synaptic desynapsis," occurs in both the central and peripheral nervous systems. One of the most prominent examples of synaptic desynapsis in the central nervous system is observed in the cerebellum, where connections between climbing fibers and Purkinje cells are modified. This phenomenon has been widely studied in rodents, where multiple climbing fibers innervate Purkinje cells immediately after birth. In rodents, by the third week of life, each Purkinje cell is innervated by only one climbing fiber. This parallels synaptic desynapsis at the neuromuscular junction between motor axons and muscle fibers in the peripheral nervous system. Perinatally, each muscle fiber is innervated by approximately 10 motor axons, but immediately after birth, the axons begin to remove synapses from some muscle fibers.

[0115] While it was previously believed that neural plasticity declines significantly with age, it has become clear that the cerebellum, in particular, maintains a high degree of neural plasticity. Climbing fibers are now thought to transmit "learning-facilitating" signals essential for synaptic plasticity and learning in the cerebellar cortex throughout life. Climbing fibers regulate the synaptic connection strength between parallel fibers and the dendritic tree network. Several theoretical models have been developed to explain sensorimotor calibration based on synaptic plasticity within the cerebellum. At least four principles have been identified as important foundations of cerebellar function: feedforward processing, divergence and convergence, modularity, and plasticity.

[0116] Signal processing in the cerebellum is almost entirely feedforward. That is, signals travel in a unidirectional direction within the system, from input to output. The cerebellum is a highly deterministic system. Signals enter the circuit, are processed sequentially at each stage, and then ejected. The cerebellum provides a rapid and clear response to a specific group of stimuli. Feedforward motor control occurs during the motion planning stage. For example, when dropping a weight held in an outstretched arm, the ankles and hips predict and correct the shift in the body's center of gravity upon release. This action is performed unconsciously, but it is a feedforward process that positions the body appropriately before the event occurs. In the human cerebellum, input information from 200 million "mossy fibers" diverges to 40 billion "granule cells," which transmit signals along "parallel fibers," and finally converges into 15 million "Purkinje cells." Due to their vertical alignment, approximately 1,000 Purkinje cells belonging to a specific processing function can receive input from up to 100 million parallel fibers while concentrating their output on fewer than 50 so-called "deep cerebellar nuclei" cells. Thus, the cerebellar network receives relatively few inputs, processes them in a very extensive and highly parallelized internal network, and then sends out the results through a very limited group of output cells—this is divergence and convergence. The cerebellar system is thought to be divided into functionally almost independent modules, numbering from several hundred to several thousand. All modules have similar internal structures, but their inputs and outputs differ. Different modules share inputs from mossy fibers and parallel fibers, but otherwise appear to function independently, and the output of one module does not significantly affect the activity of other modules.

[0117] The most crucial aspect of motor learning is that both the synapses between parallel fibers and Purkinje cells, and the synapses between mossy fibers and deep nuclear cells, possess the property of being able to change their strength. In a single cerebellar module, inputs from up to one billion parallel fibers converge on a group of fewer than 50 deep nuclear cells. The influence of each parallel fiber on these nuclear cells is adjustable. This configuration provides extremely high flexibility in fine-tuning the input-output relationship in the cerebellum, and this plasticity is precisely what the methods described herein (and related devices and systems) aim to utilize.

[0118] Over years of strengthening of the nervous system and reconstruction of Purkinje cell dendrites, a hardcoded map of neurosensory signals corresponding to each desired movement is constructed within the cerebellum. This is often referred to as the “internal model” of motor function. When a desired movement returns sensory information148 and150 that contradicts the hardcoded expectations for that movement, the cerebellum acts as an inhibitory brake on that motor output. Therefore, when changes occur in the body's sensory system due to injury or surgical intervention, an inhibitory process consistent with the process of arthrogenic muscle inhibition is likely to occur within the cerebellum. Furthermore, the excitability of the corticospinal tract is significantly reduced after injury or surgical intervention. This is thought to be the cause of the observed muscle weakness and is directly attributable to the mismatch between the altered sensory input and the cerebellum's hardcoded motor mapping to that sensory input. Therefore, musculoskeletal rehabilitation needs to focus on ways to enhance neuroplasticity and efficiently retrain the brain to a new normal state for altered sensory signals.

[0119] The second major component of the neuromuscular system includes the peripheral nervous system and spinal reflex pathways. Figure 7 is a schematic diagram 160 of the spinal reflex pathways associated with resting human lower limb control, and in the lower limb shown in the sagittal section, elements similar to those in the previous diagram are denoted by the same symbols. In the axial section of the spinal cord 162, which corresponds to the motor control of the quadriceps femoris 42 and hamstrings 44, ascending and descending corticospinal tracts 164 (often called white matter) and focal spinal reflex pathways 166 (often called gray matter) are included, with a boundary 168 between the two regions. As explained in Figure 5B, for the quadriceps femoris 42 to contract and lift the lower leg, the hamstrings 44 must be inhibited and stretched at the same time as the quadriceps femoris 42 contracts.

[0120] Cortical drive initiates voluntary contraction of the quadriceps femoris muscle via efferent signals from the central nervous system. These signals travel down the lateral corticospinal tract 170 to the relevant slice of the spinal cord 162, where they cross the boundary between the lateral corticospinal tract 172 and the gray matter 166. The distal end of the superior motor neuron 174 synapses with both the proximal end of the inferior (α) motor neuron 178, which innervates extraspindle muscles and generates force-generating contractions, and the proximal end of the γ motor neuron 179, which innervates intraspindle muscle fibers. The α motor neuron 178 transmits afferent signals 180 toward the quadriceps femoris muscle 42, and the neuromuscular junction or synapse 182 excites and contracts the corresponding multifiber monomotor units of each external rotator muscle within the quadriceps femoris muscle 42. If the motor units in the antagonist hamstrings 44 are suppressively stretched, while the majority of available motor units in the agonist quadriceps femoris 42 are suddenly excited, a sudden and rapid maximum force leg lift can occur. However, when attempting to lift the lower leg with slow, controlled movements for precision or a specific response, a more complex and coordinated process emerges between the corticospinal command signals of the central nervous system and the feedback system of the spinal reflex system.

[0121] Skeletal muscles are not merely motor organs; they contain a unique proprioceptive sensory system within their muscle belly. As shown in Figure 7, the quadriceps femoris muscle 42 has its own sensory system called the muscle spindle 184. This is enclosed in a sheath (spindle), surrounded by outer spindle muscle fibers 182, and connected to motor neurons 179 and sensory neurons 186 that communicate with the spinal cord. The muscle spindle contains intra-muscle fibers, which are much thinner than extra-muscle fibers, and therefore do not play a role in generating force-generating movements, but rather in sensing the contraction state of the quadriceps femoris muscle 42. Intra-muscle fibers run parallel to extra-muscle fibers. The main sensory afferent neurons of the muscle spindle, type Ia and type II afferent fibers, provide sensory signals regarding the length of the intra-muscle fibers and their rate of change. When type Ia and type II neurons are activated, afferent signals are sent to the dorsal horn of the spinal cord 190, where they connect with gamma motor neurons 179 in the anterior horn of the spinal cord. Efferent signals transmitted through gamma motor neuron 179 cause contraction of intramuscular fibers within the muscle spindle. Sensory afferent Ia and II neurons and efferent gamma motor neurons form a loop called the gamma loop or gamma spindle system. This gamma spindle system makes the muscle spindle a central component in regulating the state of muscle contraction. Even in the resting state of the muscle spindle, known as muscle tone, the gamma spindle system is always active. When the quadriceps femoris muscle 42 is stretched, the change in its length is transmitted to the intramuscular fibers within the muscle spindle, which are subsequently stretched. This activates the sensory afferent Ia and II fibers of the muscle spindle, and signals 188 are transmitted to gamma motor neurons via the spinal cord's dorsal horn. The efferent gamma motor neurons relax and lengthen the intramuscular fibers within the muscle spindle, maintaining balance with the quadriceps femoris muscle. Similarly, the reverse process occurs when the quadriceps femoris muscle contracts and shortens. The intramuscular fibers of the muscle spindle relax, and the afferent sensory type Ia and type II fibers respond by sending action potentials, connecting with gamma motor neurons and causing the intramuscular fibers to contract and shorten. This process maintains sensory sensitivity within the muscle.

[0122] Alpha motor neurons 178 at the neuromuscular junction 182 innervate extraspindle muscle fibers 183 that cause force-generating contractions. Meanwhile, gamma motor neurons 179 innervate intraspindle muscle fibers within muscle spindles 184, regulating the sensitivity of the muscle spindles. Gamma motor neurons regulate the activation level of alpha motor neurons via the muscle spindle system. When alpha motor neurons contract the quadriceps femoris muscle 42, the corresponding type I A and type II afferent fibers within the muscle spindle are activated. This involves inhibitory interneurons 192 in the spinal cord, which suppress the activation of alpha motor neurons in the opposing hamstring antagonist muscles 44. As a result, the hamstrings relax in relation to the quadriceps femoris by reducing the contraction of the opposing muscles. This is called mutual inhibition. Mutual inhibition enables a synchronized and coordinated response between smooth, controlled movement and opposing rigidity. The precisely coordinated dynamic interactions between afferent signaling, α / γ motor neuron signaling, and mutual inhibition of opposing muscles are crucial in generating spontaneous and targeted responses that enable smooth and efficient neuromuscular manipulation.

[0123] Unfortunately, problems arise in this mutual inhibition in patients who have undergone anterior cruciate ligament reconstruction or total knee arthroplasty. As widely reported in electromyographic studies, these patients experience co-activation or co-contraction of the quadriceps and hamstring muscles, leading to knee stiffness and rigid gait as a protective strategy. Furthermore, gamma motor neurons that regulate the gamma spindle muscle system are known to be regulated from ascending centers in the central nervous system, such as the cerebellum, which contributes to arthrogenic muscle inhibition. This is supported by studies that have shown changes in corticospinal tract and spinal reflex excitability in patients with anterior cruciate ligament injury ("Rush et al. Assessment of quadriceps corticomotor and spinal-reflexive excitability in individuals with a history of anterior cruciate ligament reconstruction: a systematic review and meta-analysis. Sports Med. 2021 51(5): 961-990.").

[0124] In summary, injury or surgery is thought to cause changes in sensory input, and the resulting changes in the higher centers of the cortex and cerebellum affect cortical drive, interacting locally within the gamma spindle cell system. This precisely tuned system loses sensitivity, impairing its ability to apply the right force to the right movement at the right time. If this dysfunctional system is left untreated, it is likely to remain in a suboptimal state. This has a significant impact on patient function, and it is not surprising that at least one in five patients are dissatisfied with total knee arthroplasty.

[0125] Afferent signals 188 from muscle spindles are transmitted to the spinal cord 162 via sensory neurons 186. The cell bodies (or dorsal root ganglia 190) of these sensory neurons 186 are located outside the spinal cord. Sensory neurons 186 transmit afferent feedback signals 188 to motor neurons 178. This transmission occurs through a feedback process involving neurotransmitter exchange between presynaptic and postsynaptic cells 176, regulating the overall efferent signals that drive the contraction of the quadriceps femoris muscle 42, enabling controlled, smooth, and coordinated movement of the lower leg.

[0126] The process of fine motor control for the contraction of the quadriceps femoris muscle 42 must be accompanied by corresponding inhibitory stretching of the hamstrings 44. Certain muscles can only exert force in one direction, namely in the contraction direction; there is no force in the stretching direction. Therefore, the contraction and stretching of antagonistic muscles are the result of an increase and decrease in overall efferent signals, respectively. Muscle spindles 184 provide afferent feedback information 188 regarding the actual state of quadriceps femoris contraction. This information undergoes phase reversal via interneurons 192. The increase in afferent signals 180 due to feedback results in a decrease in afferent signals 194 transmitted to the hamstrings 44 via hamstring lower motor neurons 196. For simplicity, this simplified Figure 7 does not show the exit of hamstring upper motor neurons from the lateral corticospinal tract 172, their corresponding muscle spindle sensors, or the feedback to the quadriceps femoris via similar intermediate neuronal pathways. The inventors do not intend to discuss synchronous inhibitory elongation of the hamstrings from the corticospinal pathway, although this process is easily understood by those skilled in the art. Only one alpha motor neuron (196) is shown in the hamstrings, but muscle spindles, type Ia and type II motor neurons, and gamma motor neurons are also present (not shown for simplification). Beta motor neurons (not shown) are also involved in the innervation of both intrafuscal and extrafuscal muscle fibers, but their function is outside the scope of this paper.

[0127] It is important to emphasize that this is a simplified explanation of the neuromuscular pathways of the spinal reflex system. Numerous reflex pathways responsible for excitatory and inhibitory reflex control of the lower leg flow from the sensorineuromuscular junctions of other major muscle groups into each of the 162 slices of the spinal cord. An important point to note in this paper is that the excitation and inhibition of opposing muscle groups must function synchronously and in coordination for smooth neuromuscular control.

[0128] In patients undergoing ACL reconstruction, alterations in the excitability of both the corticospinal tract and spinal reflex pathways occur, and there is growing evidence suggesting that these alterations may contribute to quadriceps muscle dysfunction after ACL reconstruction. Specifically, the excitability of the corticospinal tract appears to be significantly reduced, and this is partially compensated for by increased excitability of the spinal reflex pathways. Acute muscle injury (AMI) is recognized as one of the major barriers to complete muscle recovery after injury or surgical intervention, as is well known in typical cases of ACL injury and total knee arthroplasty.

[0129] Considering the function of the cerebellum's motor processing system in particular, AMI is thought to be consistent with the cerebellum's error control inhibition mechanism and the decrease in corticospinal tract excitability. After injury or surgical intervention, the combined afferent sensory feedback received by the cerebellum from numerous muscle spindles 184 does not match the expected response to specific motor commands initiated by the motor cortex. This is analogous to a pattern-matching state machine. The altered afferent signals from climbing fibers do not match the pre-programmed pattern of parallel fiber synaptic connections to the Purkinje cell dendritic tree. Normal feedforward processing falls into an error state that contradicts the pre-programmed "logic," suppressing the output of Purkinje cells. As a result, an overall decrease in corticospinal tract excitability is observed. Thus, AMI can be understood as the body's natural protective mechanism against the mismatch between received afferent information and expected afferent information. Antagonist muscles around the joint co-contract, restricting movement and causing dynamic joint rigidity, affecting fine motor control. This can also be described as a weakening of central motor function responses and an enhancement of peripheral motor responses. Another perspective is that the motor emphasis is increased on the fine motor feedback process. Instead of providing fine-tuning to the broader corticospinal drive, the modulating process of the spinal reflex pathway becomes dominant, and the drive to the activating muscle motor unit becomes a jerky stopping and initiation motion, possibly due to amplified excessive inhibitory braking by the antagonistic muscle groups. This highlights the importance of targeting both the spinal reflex pathway and the corticospinal pathway in rehabilitation to normalize quadriceps function after ACL injury or reconstruction.

[0130] Arthrogenic muscle inhibition is a major cause of muscle weakness, muscle atrophy, and poor motor control in rehabilitation from trauma and surgical interventions, as well as in aging and sedentary populations. Movement needs to be understood as a closed-loop neuromuscular "system." Commands are sent via efferent signals to move the limbs along defined pathways. Afferent information provides feedback of the actual movement to the commanded movement, and the motor cortex (and other higher-order functions) modifies the command to improve and fine-tune motor control. As mentioned above, when injury, surgery, or joint dysfunction occurs suddenly, the afferent information of the new or altered joint no longer matches the brain's model of how the joint should respond to afferent signals or commands. We hypothesize that the brain responds by inhibiting movement as a protective mechanism. This causes the antagonistic muscles around the joint to co-contract and restrict movement, and seeks other inputs, such as visual or cerebellar input, to modulate motor function. The result is dynamic joint stiffness, awkwardness, AMI (abnormal movement impulse), and loss of control. Furthermore, as mentioned above, even in cases of unilateral injury, this protective mechanism is observed to manifest bilaterally.

[0131] Therefore, rehabilitation needs to focus on retraining the brain to anticipate new afferent information flows for movements commanded to chronically altered joints. Similar to learning to walk for the first time, the neuromuscular system must learn how to manipulate new joint morphologies. The brain must be trained to recognize this new normal state. Thus, we propose a method for evaluating neuromuscular control of target musculoskeletal joints. This provides a baseline and enables evaluation of the progress of rehabilitation programs. Using this information, we can design a rehabilitation program, "Neuromodulatory Therapy (NMT)," that provides a pathway to functional recovery. NMT is a process that prepares the brain, promotes neuroplasticity, and releases corticospinal tract drive. This activates previously inhibited motor units, increases overall recruitment of motor units, significantly increases muscle strength, and consequently enables more advanced fine motor control. NMT therapy utilizes embodiments of methods for evaluating neuromuscular control and repetitive movements (or actions) based on deformation. In some embodiments, NMT therapy utilizes feedback and feedforward movements using a movement device equipped with a measuring device called an NMT device or NMT system. Feedback exercises allow users to adjust the amount of effort they put into the device, while feedforward exercises require them to predict the amount of effort needed to achieve a target level. Rather than simply repeating exercises to restore muscle strength, this approach forces the brain to pay attention to sensory feedback, thereby enabling the brain to relearn control of the target joint. Interestingly, unilateral neuromodulation therapy suppresses the effects of arthrogenic muscle inhibition (AMI) bilaterally. That is, neuromodulation therapy on one limb reduces AMI in both that limb and the contralateral, homogeneous limb.

[0132] Figure 22 is a flowchart illustrating an embodiment of neuromodulatory therapy 520. In step 522, the user is instructed and / or instructed using a device to perform a plurality of movements, including movement of at least one target musculoskeletal joint. The plurality of movements include one or more feedforward movements and optionally one or more feedback movements. In step 524, the user is provided with a presentation of one or more target parameters for at least one of the plurality of movements. At least one of the plurality of movements includes one or more feedforward movements. The presentation is provided for one or more presentation periods over the duration of each movement, and during the performance of a feedforward movement, the presentation is shielded for at least a portion of one or more presentation periods over the duration of the feedforward movement. The presentation period can be for the entire duration of the movement or for a portion of the movement duration. For example, the user may be instructed to perform the movement for a period such as 30 seconds. If a feedback movement is performed, the presentation is provided for the entire duration of one or more presentation periods over the entire duration of that movement. That is, the presentation is not suppressed, in contrast to an equivalent feedforward movement. When the user performs at least one of several exercises, one or more target parameters are measured over one or more capture periods (step 526). The measured target parameters are used to provide feedback to the user (step 528). The capture period may be the same as or different from the presentation period. The user may be instructed to match the target parameters in real time during the presentation period. Furthermore, each presentation period may be the time to complete at least one complete exercise (e.g., one set or one cycle) or the duration of the exercise (e.g., three sets of exercise or 30 seconds of continuous activity). The exercise consists of one or more movements, and the user may be instructed to perform a single movement, to repeat an exercise multiple times (i.e., repeat one or more movements N times), or to perform an exercise continuously for a certain period of time (i.e., continue repeating one or more movements). The use of presentation and capture periods allows for flexibility in the treatment method depending on the exercise being performed.For example, the presentation period can be the entire duration of the exercise, while the capture period can be set to be shorter, such as by excluding the initial warm-up and cool-down periods. For example, in a 30-second exercise, setting the warm-up period to 5 seconds would result in a presentation period of 30 seconds and a capture period of 5-30 seconds or 5-25 seconds (including the warm-up and cool-down periods). It is also possible to exclude the warm-up and cool-down periods from the presentation period, allowing the user to start exercising or using equipment before the presentation is presented. For example, in a 30-second exercise, the presentation period could be 5-25 seconds. In another example, the exercise may be long, and the presentation and capture periods may begin after fatigue has occurred. For example, if the exercise time is 300 seconds, the presentation period can be set to 60 seconds, spanning 200-260 seconds. In one embodiment, a second warm-up period is provided before the start of the capture period, allowing the user's movements to be adjusted to the presentation content before they are measured. For example, in a 30-second exercise, the presentation period can be 5-30 seconds and the capture period 10-30 seconds. A cool-down period can also be included. In some embodiments, multiple presentation periods can be set during the exercise period. For example, a system can be considered where 0-15 seconds and 20-30 seconds are set alternately at 5-second intervals. Similarly, multiple capture periods can be set, which may be the same as or different from the presentation periods. In the case of exercises repeated at a fixed frequency, the capture period can be synchronized to a specific phase of the exercise, and its duration can be an integer multiple of the exercise period. For example, in the case of an exercise tracking a sinusoidal force fluctuating for 30 seconds at a frequency of 0.3 Hz, two capture periods can be used, each synchronized to the zero-phase point (x-axis intersection), with each period being 3 cycles (10 seconds). Feedback presentations are provided during or after the exercise and may include presentations of measured values ​​or presentations derived from measured values ​​based on comparison with target parameters, functioning as feedback to help the user match the target parameters during the current or future exercise.

[0133] In one embodiment, the neuromuscular control of a target musculoskeletal joint during one or more movements is evaluated by determining one or more differences between a target parameter and a measured parameter over one or more capture periods. This evaluation or difference is used as a trigger to change the proportion of presentation periods during which presentation is suppressed during feedforward movement, and the phase, duration, or complexity of the suppression can be changed. For example, if the user shows an improvement in control ability, the complexity can be increased, and if the user shows a decline in control ability, the complexity can be decreased. The evaluation or difference is also used to evaluate the smoothness of training. In one embodiment, the evaluation of neuromuscular control of a target musculoskeletal joint can be provided to the user and / or clinician, for example, by providing a presentation to the user or clinician, or by generating an electronic report (e.g., Word, PDF, Excel file) and sending it by email or saving it to an electronic storage device (e.g., hard disk, cloud storage, website) (user login / authentication required to access the report). Furthermore, the evaluation of neuromuscular control of a target musculoskeletal joint can be carried out as an independent method, and Figure 23 shows a flowchart of a method 540 for evaluating neuromuscular control of at least one target musculoskeletal joint. In this embodiment, in step 542, the user is instructed and / or instructed using a device to perform one or more movements, including movement of at least one target musculoskeletal joint. In step 544, the user is provided with a presentation of one or more target parameters for at least one of the one or more movements for one or more presentation periods. The user is instructed to attempt to match the one or more target parameters in real time. While the user is performing one or more movements, one or more target parameters are measured as a function of time over one or more capture periods (step 546). Then, one or more differences between one or more target parameters and their measurements are determined over one or more capture periods (step 548). Then, using the determined one or more differences, an assessment of neuromuscular control of at least one target musculoskeletal joint is created and the created assessment is reported electronically (step 550).Reports are provided via screen displays during and / or after exercise, or as electronic documents (including those electronically transmitted or stored, requiring the user to log in / authenticate to access the report) provided to the user and / or clinician.

[0134] Each exercise is either dynamic or static, and each involves one or more movements or the repetition of the same movement for a set period of time. Dynamic exercises involve activating one or more muscles associated with a target musculoskeletal joint and moving the target musculoskeletal joint over one or more joint angle ranges. The number of joint angle ranges usually depends on the nature of the joint and the disability or injury. For example, the knee joint is a hinge joint that allows movement in one direction, so there is only one joint angle range. In contrast, the shoulder joint allows three-dimensional movement of the arm, so there may be one, two, or three joint angle ranges depending on the specified exercise. Static exercises involve activating one or more muscles associated with a target musculoskeletal joint while holding the joint in a stationary position at a fixed joint angle. For example, the user may be instructed to activate muscles at different force levels while holding the joint at a fixed joint angle.

[0135] The user may be instructed to perform a single movement, multiple coordinated movements, or a series of movements. Each movement may consist of repeating a single movement or multiple movements, including coordinated movements, in an ordered sequence. In some embodiments, the user is instructed to perform the movement using a specific device (a neural control device, more simply, an NMT device). This may be based on conventional gym equipment appropriately equipped with measuring instruments as described herein, or it may be a device specifically designed as described herein. In some embodiments, a collaborative robot or other similar device may be used, configured to instruct the user to perform the movement. In these embodiments, the user may further be instructed on what actions to take as responses and may use the collaborative robot (or other device) to measure target parameters. For example, the user may be instructed to grasp an end effector that follows a specific path and to resist its movement.

[0136] For at least one of one or more movements, a target parameter presentation is provided for one or more presentation periods. This can be a static (constant) value or a dynamic value, and the user is instructed to match the target parameter level in real time. For example, the presentation may be a numerical value, shape, or curve presented on a display device of computer device 212, and / or a volume level from an auditory device such as a speaker or headphones, and / or tactile feedback from a tactile device. The target parameter may be a periodically changing force, such as a sinusoidal force that changes at a specific frequency and amplitude during the duration of the movement. The target parameter may be a force, a joint or limb position, a joint angle, acceleration, or other similar parameter related to the movement of a target joint. Sensing devices may be used to measure, sample, or capture the value of a parameter at a specific point in time and transfer this value or its presentation to the computer device. For example, a sensor may take a sample at a specific timing or continuously sample at a sampling rate. Sensing devices may perform onboard processing of the signal before transmitting it to the computer device. For example, when measuring force, a force transducer or load cell can be configured to capture a measurement, or a series of measurements at a sampling rate, and transfer the force measurement to a computer device 212. Steps 524 and 528 can be integrated by presenting the target parameter and feedback presentations, such as the measurement parameter, as a function of time, and optionally presenting the difference between the target parameter and the measurement parameter as a function of time. In one embodiment, this presentation is a comparison chart presenting both the target parameter and the measurement parameter, or both compared, as real-time or instantaneous measurements, either alone or superimposed on a visual presentation of the target parameter, representing the difference between the target value and the measurement value.

[0137] In another embodiment, the difference between the target parameter and the measured parameter may be represented by changes in the pitch and volume of an audible sound, or by changes in the frequency and / or amplitude of tactile feedback. The presentation period and the capture period may be the same, partially overlapping, for example, the presentation period may be a subset of the measurement period, or they may be distinct periods. In one embodiment, the measurement period may be a single continuous period, while multiple presentation periods may be used, at least some of which are included in the continuous period.

[0138] As will be readily apparent to those skilled in the art, such parameters may be parameters such as force, or any of the relevant parameters measurable using the apparatus described herein, such as position, joint angle, acceleration, or other relevant parameters. Furthermore, the target value does not need to be a static value and may vary in amplitude, frequency, phase, or in a parametric curve such as a sine wave, sawtooth wave, or polynomial, and may be provided as a time series / curve presentation with the x-axis representing time and the y-axis representing the value of the target parameter. As will be discussed later, in some embodiments, parts of the curve or time series may be suppressed or occluded. Determining the difference between the target parameter and the measured parameter involves calculating an error value at a specific point in time or time range, and the analysis may involve performing a mathematical or statistical analysis of the error value.

[0139] The evaluation method (steps 532 and 550) can generate and report an evaluation of neuromuscular control of a target musculoskeletal joint using one or more differences. This can be done by determining one or more ranges of the target parameter and / or one or more joint angle ranges in which the user lacks control of the target musculoskeletal joint, using one or more differences. In one embodiment, the evaluation may include performing a statistical analysis of one or more errors to characterize the areas in which the user lacks control of the target musculoskeletal joint. In one embodiment, predetermined thresholds and / or statistical / computational methods may be used to evaluate the areas in which the user lacks control. For example, areas exceeding or crossing any of the predetermined thresholds. In one embodiment, reporting the evaluation of neuromuscular control may include presenting the differences (e.g., the graph comparison described above) on a screen. A software module running on a computer device may be configured to generate an evaluation that includes collecting measured differences, performing statistical analysis, and / or estimating the range in which control loss occurs. It is possible to process multiple difference values ​​to determine the range.

[0140] Difference generation and evaluation reporting can be performed for a single movement or a series of movements. That is, the user performs multiple different movements or repeatedly performs the same movement, and the evaluation is reported after all movements are completed. It is also possible to perform evaluations for each movement or each action within a movement, and report only at the end. The report is displayed on a display device or written to an electronic file such as a spreadsheet or PDF document and stored on an electronic storage device. To prevent unauthorized access to the report, access control restrictions such as passwords or storage on password-protected devices or sites are used. The report is sent to a third party, such as the patient or clinician, or to a computer storage device, including cloud storage. In some cases, the report may be an internal report in which the values ​​generated by one software module are reported to another software module or processor, or it may be stored in memory or written to an electronic file until all movements are completed. Additional information such as the user's medical history, past injuries, and surgical information may be considered when determining range of motion that is beyond the user's control. For example, range of motion may be permanently limited due to past injuries or surgeries.

[0141] Embodiments of NMT and the evaluation of neuromuscular control can be modified and presented in slightly different ways. For example, in one embodiment that provides the presentation of target force levels, the step of measuring force and determining the difference can be equivalently considered as the step of determining the accuracy with which the user performs one or more movements, and the evaluation may include providing the user with real-time feedback on the accuracy. Further embodiments of the above method form the basis of NMT-based rehabilitation, developmental programs, or ability optimization methods, which involve repeating the above method or its variations at multiple different times. This is performed as a set of multiple movements (each movement may include multiple actions), and a session consists of multiple sets of movements, with one or more sessions performed on different days. A set or session consists of an evaluation movement in which the user evaluates and reports the range of uncontrollable movement, and a feedback and feedforward therapeutic movement (in which the user selects a target parameter based on the range of uncontrollable movement (based on the previous evaluation)). In the therapeutic movement, the user is given feedback on the measured value of the target parameter. In some movements (or embodiments), this is a presentation of the measured value or a summary presentation of the measured value, and no direct comparison with the target parameter is made. That is, the step of determining the difference between the measured value and the target parameter is omitted. Similarly, even if a difference is measured, evaluation and reporting of the evaluation results are optional. The difference or evaluation of the difference may be used as a trigger for a change in the complexity of the movement. Feedback presentation may include presenting the difference between the measured value and the target parameter, instead of determining one or more ranges of the target parameter and / or one or more joint angle ranges in which the user lacks control over the target musculoskeletal joint. That is, the evaluation of neuromuscular control performed during an NMT session (or multiple sessions) may be minimal (e.g., at the start and / or end of the session) or not performed at all. In some embodiments, the difference is calculated periodically, such as during a weekly session, or on request, and used to determine when to trigger a change in the complexity of the movement, such as in a review session with a clinician.For example, a user can perform NMT therapy at home and determine whether changes to the therapy are necessary through regular review sessions with a supervising clinician. In one embodiment, the differences are utilized by the NMT device's calculation (or control) unit, which automatically changes the complexity of the exercises in response to the fulfillment of trigger conditions. This enables the automation of NMT. ​​In another embodiment, the trigger conditions are pre-set and then reviewed and adjusted by the clinician during the course of treatment.

[0142] Figure 24 shows a flowchart of a method 560 for rehabilitation, development, or ability optimization based on neuromodulatory therapy, according to one embodiment. First, in step 562, an assessment of neuromuscular control is performed according to method 540 shown in Figure 23. Next, in step 564, a treatment program is determined that includes the presentation of one or more target parameters, a series of feedback and feedforward movements, and one or more sessions of inhibition. These may be designed to target areas of insufficient control of target musculoskeletal joints based on the assessment in step 562. In one embodiment, a sequence of inhibitions to be used over multiple sessions may be determined. Next, in step 566, one or more NMT sessions including feedback and / or feedforward movements are performed. Then, in step 568, a further assessment of neuromuscular control is performed to confirm whether sufficient improvement has been achieved. If sufficient improvement has not been achieved, the process returns to step 566 and additional NMT sessions are performed. If sufficient improvement has been achieved, the process proceeds to step 570, where the proportion of feedforward movements and / or the complexity of inhibition in the feedforward movements is increased, or the process terminates when sufficient neuromuscular control has been achieved.

[0143] Practice can be further categorized into feedback and feedforward exercises, or sets of exercises (each set consisting of one or more movements). For example, after conducting a neuromuscular assessment to identify areas of the user's control deficit, a target parameter can be selected that changes the entire range of motion, or a portion thereof, where the deficit occurs, and the user can be guided to focus their attention on that range of motion. Each set may consist of different exercises, the same exercise with a modified range of target parameters, or with different target parameters. Similarly, different sets may be identical, each set may be different, or some sets may be repeated. Sets can be organized into sessions. The selection of exercises and the range of target parameters used within a set may be determined based on an initial assessment of neuromuscular control, or based on performance in previous sets, and may be updated or modified as the user progresses.

[0144] For example, a treatment method or therapeutic exercise may include, in step 522, instructing the user to perform one or more exercises, and in step 528, providing the user with feedback on one or more measured target parameters. This may be real-time feedback where the measurement values ​​are presented in real time, including real-time tracking of the target parameters or real-time presentation of the difference between the measurement value and the target value. This presentation may also be a summary presentation provided after the exercise or after a series of exercises (such as average precision or the percentage of time within a threshold of the target value). Alternatively, it may be a classification-based presentation (e.g., a red, orange, green traffic light indicator) based on the precision or difference between the target value and the measurement value of the target parameter (e.g., the percentage of time during the exercise when the error falls within a predetermined error range). In the case of feedforward therapeutic exercises, the presentation of target parameters is suppressed for at least part of the exercise, and possibly throughout the entire exercise. This requires the user to predict or estimate the force or control amount needed to match the target parameter in the suppressed portion during the performance of the feedforward exercise. In some embodiments, the suppression can be set to present only future target values ​​or a set of future target parameter values. For example, a curve with one or more parts occluded may be presented, or a target value to be reached at a specific point in the motion (such as a peak value) may be presented. Feedback presentation of the target parameter may also be provided while the target parameter is suppressed. Alternatively, both the target parameter and the feedback presentation may be suppressed simultaneously. As will be discussed later, feedback motion may progress to feedforward motion.

[0145] As mentioned above, this method can be implemented using neuromuscular therapy (NMT) devices or systems. These NMT devices may be custom-made or exercise or gym equipment that has been appropriately modified to enable the measurement of neuromuscular control, such as by integrating resistance elements and sensing devices such as load cells. Musculoskeletal control is characterized by the ability to exert the required force in a coordinated manner at each of several defined joint angles. Therefore, although muscle strength alone is not the primary determinant of rehabilitation progress, resistance strength training equipment and techniques can be modified for use as NMT devices by adding resistance elements, or extension components with resistance elements, and sensors or sensing devices. The extension component may be an elastic resistance band, spring, or similar component. Sensors or sensing devices are used to measure the force applied by the user, and sensors may include force transducers, strain gauges, load cells, and accelerometer-based sensors. Force can be measured as a function of time (i.e., time-series measurements can be obtained by sampling force measurements at a fixed sampling rate or a sampling rate that varies depending on the movement being performed), and the degree of neuromuscular control can be determined by measuring it at a specific joint angle or range of joint angles. In other embodiments, the sensor or sensing device may be non-force-based, such as an angle sensor or a position sensor (i.e., measuring a point in three-dimensional space), or it may be a remote sensing technique, such as a computer vision-based method configured to remotely measure joint angles during movement to determine the degree of neuromuscular control.

[0146] Those skilled in the art will readily understand that extension and flexion refer to the movement of specific joints, such as the knee. However, embodiments of this method can be used to evaluate all joints and muscle tissues. Therefore, the devices for extension and flexion should be understood to include other joint movements and their corresponding devices, namely abduction, adduction, varus, eversion, rotation, and all other joint movements.

[0147] Figure 8A is a sagittal schematic diagram 200 of a neuromodulatory therapy (NMT) device configured for use in knee joint muscle training according to one embodiment. Elements similar to those in prior drawings are denoted by the same reference numerals. The NMT device comprises, as a first part, an extension device 202 consisting of a linear guide rail 204 and a slide carriage 206 that is freely displaceable along the guide rail. The slide carriage 206 is attached to a resistance element 208, which is further rigidly connected to a sensing device such as a force measuring device 210. This sensing device is rigidly attached to the device 202 proximal to the seated position of the user 28. Furthermore, the NMT device may comprise, or integrate, a computer device 212 connected to the force measuring device 210 of the extension device 202 via a data cable 214 as a second part. Alternatively, the NMT system may include the NMT device 202 and a computer device 212 configured to analyze data from the force measuring device 210 according to an embodiment of the method described herein. The computer device may be connected to the sensing device via a wired connection through a data cable 214 or via a wireless connection. Alternatively, the NMT system may include an NMT device 202 and a software module running on the computer device 212 and configured to implement embodiments of the method described herein. Multiple computer devices may also be used, for example, a first computer device configured to calculate the difference and / or analyze the difference measurements, and a second computer device for presenting the results (e.g., the difference or ranges beyond the user's control). The resistance element 208 is shown as a spring in the schematic diagram. This may be provided by a coiled wire spring as a tension spring 118, as explicitly shown in Figure 5B. Figure 5B is reconstructed, and the resistance element may be provided as a compression spring, a torsion spring, a leaf spring, or other form of spring that is readily understood by those skilled in the art. Similarly, other forms of resistance elements may be provided, but not limited to, elastic materials such as rubber (such as TheraBand™) or elastic ropes in the form of bungee cords or shock cords. In this embodiment, the first part of the NMT device is referred to as the extension device.This refers to a functional movement that extends the distal portion 26 of the leg, the opposite of flexion. Throughout this specification, for the sake of consistency in the discussion, the first part of the NMT device will be referred to as the extension device. However, those skilled in the art will readily understand that the NMT is also applicable to other joints of the body.

[0148] The knee joint is a strictly limited joint, capable only of flexion and extension. The elbow joint can flex and extend, but also has one additional degree of freedom, allowing for pronation and supination of the distal epiphysis. The wrist can flex and extend, as well as perform lateral movements called abduction and adduction. The ankle is more complex, possessing plantar flexion, dorsiflexion, inversion, and eversion, which are defined as ankle joint movements. The hip joint is a ball-and-socket joint, capable of flexion, extension, abduction, adduction, internal rotation, external rotation, and rotation. The shoulder joint is the most mobile joint in the human body. This mobility allows the upper limb to achieve a wide range of motion, including adduction, abduction, flexion, extension, internal rotation, external rotation, and 360° rotation in the sagittal plane. Covering all major joints, the spine can flex, extend, rotate, and lateral flexion. These movements occur as a combination of rotational and translational movements in the sagittal, coronal, and axial planes.

[0149] Therefore, describing the application of neuromodulatory therapy to all joint movements would be a complex and lengthy task. Thus, in this specification, the first part of the neuromodulatory device is referred to as the extension device. This does not preclude its applicability to other joint movements (abduction, adduction, pronation, rotation, and any other joint movements disclosed), each application of which will be readily understood by those skilled in the art. However, regardless of the specific joint, it will be generally understood that the device is configured to allow measurement of the target joint within a specific range of motion and to allow movement across a specific range of motion or multiple ranges of motion (i.e., one-dimensional, two-dimensional, or three-dimensional).

[0150] In the above embodiments, all resistive elements are passive. In one embodiment, the resistive elements may be active resistive elements. In this case, the resistive elements may be pneumatic or hydraulic devices that can be adapted to supply a constant or variable force over the entire range of motion as needed, through the use of appropriate sensors and / or appropriate feedback control loops. In a preferred embodiment, an electric motor is used as the active resistive element. In this embodiment, the electric motor can further be adapted to include a force or torque sensor to supply a desired force profile over the entire range of motion. In another embodiment, a force sensing device consisting of a force sensor, an inertial measurement unit (IMU), and a communication module can be used to measure the force. In this embodiment, the IMU tracks three-dimensional position and orientation data, which is transmitted wirelessly to a computer device along with force data to estimate the applied force and joint angles as a function of time during motion.

[0151] Rehabilitation often focuses on measuring muscle strength, which is highly dependent on joint angle (see reference numeral 218 in Figure 8A). Traditionally, many knee muscle strength studies have chosen a 90-degree joint angle for ease of measurement. However, the knee is most prone to loosening and instability in the mid-flexion position between 30 and 60 degrees. This coincides with the range in which patients with anterior cruciate ligament rupture report instability. Patients who have undergone total knee arthroplasty also report knee instability and weakness in the mid-flexion position at a joint angle of approximately 45 degrees. Therefore, in some embodiments, examination and treatment of these instabilities are performed at the mid-flexion point. As the user 28 extends their leg, the slide carriage 206 moves along the guide rail 204, as shown by reference numeral 216, and the knee joint 22 is moved through the range of angle 218. This angle range preferably includes mid-flexion instability. Furthermore, as those skilled in the art will understand, as the spring 208 stretches, the force acting on the sliding carriage 206 on the user 28 increases according to Hooke's Law (the force exerted by a spring is proportional to its stretch). This force serves as a surrogate indicator of the position of the carriage 206 and, consequently, the degree of extension of the patient's leg 28. In this manner, the measured force and the position of the carriage provide analogous information regarding the degree of extension or position of the patient's leg. Thus, this exemplary joint is moved over a range of force conditions and angles.

[0152] The force measuring device 210 transmits force measurements to the computer device 212 via a data cable 214. In one embodiment, the data cable 214 is a Universal Serial Bus (USB) cable, providing both power to the force measuring device 210 and a digital data connection between the force measuring device 210 and the computer device 212. As will be readily apparent to those skilled in the art, in other embodiments, but not limited to, other forms of data cables may be used, such as FireWire, Thunderbolt, Ethernet, CAN bus, I2C, or RS-4xx protocol buses. Furthermore, the data cable 214 can operate via a physical layer of copper wire or optical fiber. Alternatively, the data connection embodied in the data cable 214 disclosed herein may be provided via a wireless device using transport and protocols including, but not limited to, Wi-Fi®, Bluetooth®, Zigbee®, Thread®, LTE®, GSM® cellular networks. Force measurements can be captured at predefined sampling rates, including rates of 1 kHz or higher, or at lower rates such as 20 Hz, 1 Hz, or 50 Hz. The sampling rate can be fixed or variable and is set based on the capabilities of the sensing device or sensor, the speed and processing power of the communication link, or the complexity of the motion. For example, a controller may change the sampling rate to increase the amount of data captured during more complex motion.

[0153] By using the extension device 202, the exemplary knee joint 22 is restricted to movement only in the sagittal plane and therefore operates with one degree of freedom. Further embodiments in which the joint can operate with more than one degree of freedom will be readily apparent to those skilled in the art, and these embodiments are therefore assumed in this disclosure.

[0154] The sensing device may be a force measuring device (or force sensing device) 210 configured to measure the force applied by the user as a function of time when the user performs an exercise. Various force measuring devices may be used, but are not limited to force transducers, strain gauges, and load cell-based technologies. In some embodiments, these force measuring devices measure force (or strain) at a sampling rate of 1 kHz or higher. Load cells may also be incorporated into any force loading device as an integrated neuromuscular characterization device. The load cells are connected to a computer device via a wired or wireless link. In one embodiment, the input device includes a portable load cell with a wireless communication interface configured to transmit measured force data wirelessly to a computer device. This is the portable load cell described in PCT application PCT / AU2019 / 000078, filed on 24 June 2019, claiming priority to Provisional Application AU2018902252 filed on 22 June 2018, the contents of which are incorporated herein by reference in their entirety. In one embodiment, the portable load cell includes a mounting mechanism, such as a pair of hooks, that allows it to be temporarily attached to a force transmission component of an exercise device and added inline. In one embodiment, the portable load cell is temporarily attachable to or detachable from the exercise device, and in yet another embodiment, the load cell is permanently integrated. The load cell may be configured to measure force under dynamic conditions when a joint or adjacent joint is moving. The extension device may incorporate rigid or rigid material to maximize the force transmitted to the load cell, which is similar to the configuration when the load cell is mounted at a fixed point. In the case of mounting at a fixed point or extension devices using rigid / rigid material, the load cell measures the force applied by the user under static conditions, i.e., at a fixed joint angle or a series of joint angles. It will also be apparent to those skilled in the art that the force may act in the extension or compression direction, as required by a particular exercise or rehabilitation program. It will also be apparent that this is applicable to flexible extension devices, rigid extension devices, and fixed mounting points.

[0155] In one embodiment, a load cell is integrated into an extension device or any loading device for the purpose of measuring specific movements, specific exercises, or specific movements within exercises in an occupational therapy, gym, exercise, clinical, or rehabilitation setting. The extension device has several features that allow the load cell to be integrated, so that the system can perform measurements of neuromuscular control for specific physiological movements within a range of joint angle positions. The load cell may or may not be easily detachable from the extension device. For example, a load cell can be integrated into a thigh compression, adduction type "extension device" to enable specific measurements around the hip joint. This can also be incorporated into a handgrip device for measuring neuromuscular control of fingers, fingers, grip strength, and other joints. The handgrip device can also incorporate the wrist, so that the hand and wrist can be evaluated simultaneously or individually. Similarly, in chair, desk, or work environments, an extension device can be incorporated into the physical space to measure neuromuscular control of the trunk and neck at regular intervals as a preventive intervention and rehabilitative interaction in specific tasks.

[0156] In one embodiment, the mounting point of a portable load cell is adapted to mate with multiple accessories. Therefore, a convenient mounting point is a simple hook that allows for quick and secure attachment of multiple accessories. Measuring task-specific output of neuromuscular control is important for athletes and people performing specific tasks in the workplace. For example, baseball and cricket players need to throw balls of a specific size, shape, texture, grip, and weight. By attaching a ball to a load cell and measuring the execution of the throwing motion, the whole-body motion of applying force to the ball and the resulting final outcome can be captured. This can be easily attached and detached using a hook-and-loop (Velcro®) system. Similarly, manufacturing line workers may be responsible for repetitive motions in assembling parts using specific hand tools. For example, when a worker tightens a nut onto a bolt with a mechanical wrench, this involves applying force to prevent the tool from rotating in the hand. Measuring hand control ability can be used as an indicator of neuromuscular fatigue and contribute to mitigating the effects of repetitive stress disorder. In this particular case, a sensor inside the hand tool monitors parameters such as rotational inertia until the bolt reaches a predetermined torque setting. The final results of neuromuscular performance measurements of specific hand tools via attachments are crucial for capturing the repetitive nature of human inefficiency and its potential impact on repetitive overload injury. This can also be achieved in the form of trunk attachments for measuring neuromuscular control in individuals with lower back pain in a seated position. For example, to verify the postural control effect after prolonged sitting, a method could be used to measure neuromuscular control by instructing the subject to repeatedly press their lower back against a chair against resistance. As will be readily apparent to those skilled in the art, the embodiments described herein are readily applicable to the determination of any neuromuscular process, whether it be a control disorder or a specific target.

[0157] Attachments enable a variety of movements and functions at the target joint and can be incorporated into whole-body exercises. By using handles of different lengths, a wide range of single-joint and multi-joint movements can be achieved. Static or dynamic movements can be applied to the following attachments. For example, a swivel handle enables joint movements such as wrist flexion / extension, ulnar / radial deviation, and circular motion. Similarly, application to the elbow joint enables flexion / extension, and application to the shoulder joint enables flexion / extension, internal / external rotation, abduction / adduction, and circular motion. Handles can also be used for functional movements such as striking, making them useful in sports and vocational training. The handle's unidirectional offset structure allows for the attachment of hammer-type attachments targeting supination / pronation movements of the elbow and wrist. Handles can also be substituted with slings or wrist harnesses. They can also be used as an alternative means of replicating the aforementioned movements by pressing plates against the body. Attachments such as darts can also be used to train fine motor skills of the fingers and wrists. Javelin-type attachments, such as those used in javelin throwing, can improve the movement of the entire upper arm and trunk required in throwing sports. Ball-type attachments allow for full joint movement of the handle, along with the added advantage of being more functional in throwing and throwing activities in sports. To further enhance this, one can use a ball connected to the handle via a chain attachment, such as those used in hammer throwing. Discus attachments, such as those used in discus throwing, can also be considered. For trunk rotation, flexion / extension, lateral flexion, or combinations thereof, handles for gripping and harnesses worn on the body are important attachments that enable these movements. For the lower limbs, pedals, plates, ankle harnesses, straps, and slings can be used to enable hip flexion / extension, abduction / adduction, internal / external rotation, rotational movement, knee flexion / extension, ankle plantarflexion / dorsiflexion, inversion / eversion, and rotational movement. As those skilled in the art will understand, functional improvement is possible by applying combinations of whole-body movements using these attachments, and all attachments currently used in gyms and rehabilitation settings offer various alternative means for recovery and ability achievement.It will be obvious to those skilled in the art that a load cell is merely one form of force measuring device. In other embodiments, other types of force measuring devices, including but not limited to load cells, resistance pressure sensors, strain gauges, piezoelectric sensors, inertial measuring devices, accelerometers, etc., can be used interchangeably.

[0158] Those skilled in the art will readily understand that spring 208 represents any resistive element, including, but not limited to, springs, elastic elements such as Theraband®, and other elastic materials. In another embodiment, the extension device is designed such that spring 208 is replaced by a device that maintains a constant force regardless of the position of the slide carriage. One example of such is an attachment in which the attached weight increases as the leg is extended. Thus, in another embodiment, Figure 8B is a sagittal schematic view 220 of a leg press gym device configured for use as an extension device according to one embodiment, with elements similar to those in the prior drawings denoted by the same reference numerals. The leg press device 222 includes a set of weights 224 connected to the slide carriage 206 by a non-stretchable cable 226 via a series of pulleys 228. The movement of the slide carriage 206 along the guide rail 204 is performed with a constant force applied by the suspended weights 224. In this embodiment, the position of the slide carriage 206 is measured by a position sensor 229. The position sensor transmits position information of the slide carriage 206 to the computer device 212 via the data cable 214. In one embodiment, the position sensor 229 is a linear position encoder. That is, a sensor, transducer, or read head mounted on the slide carriage 206 is combined with a scale mounted on the guide rail 204 to encode the position. The sensor reads the scale and converts the encoded position into an analog or digital signal. This signal is decoded into position information by the computer device 212. The encoder may be incremental or absolute. As will be readily apparent to those skilled in the art, other forms of position detection are also possible, such as using a shaft encoder on one of the pulley shafts, and all of these are assumed in this disclosure. Furthermore, in one embodiment, the system may provide position information at a sampling rate of 1 kHz or higher.

[0159] As will be readily apparent to those skilled in the art, various combinations of apparatus and measurement sensor technologies are equivalently interchangeable in different embodiments of the NMT apparatus and are considered to be compatible and functionally equivalent in the spirit of this specification. Furthermore, as will be readily apparent to those skilled in the art, other forms of apparatus are also applicable to other embodiments, including, but not limited to, muscle training systems, therapeutic devices, and standard exercise / gym equipment.

[0160] Figures 8C, 8D, and 8E show another embodiment of the NMT extension device 202, similar to those shown in Figures 8A and 8B, configured for use with a chair 221. This embodiment is a portable NMT device intended for home use. Figure 8C is a perspective view configured for right knee treatment, and Figures 8D and 8E show the corresponding top and side views. The user may use a suitable chair 221 at home, or the device 202 may be provided with a chair 221. The device 202 consists of a base 203, a central shaft 205, and a rotatable support leg mechanism 207. The rotatable support leg mechanism 207 consists of an upper mounting bar 213, two legs 215, and a chair positioning connector 217. A slide carriage 206 is mounted around the central shaft 205 and has two opposing pedal mounting sections 209, each mounting section configured to receive a pedal 211. The slide carriage is connected to a resistance element 208 located inside the shaft. In this embodiment, the resistance element is a tension spring fixed to the upper end of the central shaft (where it connects to the upper mounting bar 213), and is shown by a dashed line in Figure 8C. The shaft 205 is provided with two straight guide rails 204 on either side to receive and guide the slide carriage 206. For example, the slide carriage consists of a pair of T-shaped components, and the shaft is received in the gap between the guide rails 204. The spring is biased to pull the pedal toward the upper mounting bar 213 (i.e., the top of the shaft 205). This causes the pedal to be pushed toward the base when the patient 28 sits in the chair 221, extending the spring 208. The spring 208 also applies a resistance force to the pedal when it is pulled back toward the upper mounting bar 213 (it is compressed when it returns from the extended position). As the pedal slides up and down the shaft, the internal resistance spring is extended and compressed. The base 203 is a T-shaped component that rests on the floor and may be a heavy component or have high-friction feet to prevent the base from moving during use.

[0161] The upper mounting bar 213 receives the upper end (distal to the base) of the shaft 205, and the upper ends of the two legs 215 are rotatably attached to both ends of the upper mounting bar 213. The chair positioning connector 217 connects the base-side ends of the two legs 215 and has a chair positioning section 219 in the center. In this embodiment, the chair positioning section 219 is a curved section that conforms to the contour of the shaft 205, so that when the rotatable support is folded relative to the shaft 205, the extension device 202 becomes substantially flat and compact for storage and transport. In other embodiments, the chair positioning section 219 may have a different profile or shape. The legs 215 are configured to rotatably relative to the upper end of the shaft 205, and the range of rotation of the legs 215 relative to the shaft may be limited to, for example, 0 to 25°. The pivot mounts on the legs may be configured to allow the legs to be locked at any angle within a range, to be locked only at the minimum (0°) and maximum (25°) ends of the range, or to be locked at specific intervals within the range (e.g., 5° intervals).

[0162] In one embodiment, the support legs are extended and locked at their maximum range (25°) to form a 25° incline relative to the ground. The chair legs 223 are positioned at the central chair positioning section 219 of the chair positioning connector 217 to prevent the chair 221 (and the patient 28, not shown) from sliding off the device when the patient uses the device. The support leg mechanism 207 can also be rotated and folded, allowing the device to be used in a flat position when the patient is lying supine on the floor or bed. As described above, when the patient extends their legs, the pedal 211 slides up and down along the shaft 205, extending the internal resistance spring 208. The pedal 211 is attached to the slide carriage 206 via the pedal mounting section 209, and is structured to allow the pedal 211 to rotate freely so that it maintains a neutral angle of 90° with the ankle even when the legs are extended forward. In this embodiment, the pedal 211 includes a built-in force sensor 210, such as a power meter, and a communication interface for communicating with a computer device 212, including transmitting measured force data. The communication interface can be a wireless communication interface (e.g., Bluetooth®, ANT+) or a wired interface such as a USB connector. The pedal 211 can be mounted on both sides of the shaft 205 to provide treatment to either leg. For example, to provide treatment to the right knee, the pedal 211 is mounted on the left side (viewed from above) of the shaft 205, and the right chair leg 223 is received by the central chair positioning unit 219. To then treat the left knee, the pedal 211 is moved to the right side of the shaft 205, and the left chair leg 223 is received by the central chair positioning unit 219. Alternatively, the sliding carriage 206 can be designed and configured to allow the pedal 211 to rotate or reverse from one side of the shaft 205 to the other. Alternatively, two pedals 211 can be permanently mounted on both sides of the shaft 205.

[0163] Figure 8F is a sagittal schematic diagram 225 showing another embodiment of the NMT extension device, with elements similar to those in the prior drawings being denoted by the same reference numerals. In one embodiment, the resistance element is an active resistance element or an electric motor 227. The slide carriage 206 is attached to the electric motor 227 by a non-stretchable cable 226 via a pulley 228 (however, the use of a pulley is not mandatory in other embodiments). Movement of the slide carriage 206 along the guide rail 204 occurs. In this embodiment, the position of the slide carriage 206 is measured by a shaft encoder 229 in the electric motor 227. The position sensor transmits the position information of the slide carriage 206 to a computer device 212 via a data cable 214, as in the previously described embodiment. This embodiment has advantages over a passive resistance element. When using a passive resistance element, specific parameter settings are required for each patient. Since the force is proportional to the extension, a particular spring provides a predetermined force range within a particular extension range. Users with longer legs can reach higher forces than users with shorter legs, and matching the two can lead to compromises in the resolution or dynamic range of the force measurement system. The use of active resistance elements allows for independent setting of force and extension.

[0164] In practice, the NMT extension device undergoes a simple calibration cycle to configure the system for each user. The user is seated, and the system performs the following steps: (a) Measure the user's maximum leg extension. The user is instructed to extend their legs as far as possible, and the device measures the maximum extension (by direct positional measurement or force measurement). (b) Determine the user's minimum leg extension. The user is instructed to shorten their legs as much as possible, and the device measures the maximum extension (by direct positional measurement or force measurement). (c) Determine a calibration coefficient that maps the user's range of motion to the system's required range of motion.

[0165] As NMT progresses, the user's range of motion expands, and different force profiles may be required. In the embodiment shown in Figure 8F, these parameters can be adjusted much more easily in a dynamic manner.

[0166] Strength training systems include, but are not limited to, multi-station gyms, pulley systems, cable systems, lat pulldowns, cable rows, knee extension machines, hamstring curls, hip flexion / extension / abduction / adduction machines, calf raises, bench presses, bunch pulls, pec deck machines, shoulder presses, shoulder pulls, shoulder abduction / adduction / extension / flexion machines, triceps extension machines, biceps curls, arm curls, wrist curls, trunk rotation machines, trunk flexion / extension machines, Smith machines, leg presses, etc. Therapeutic equipment includes Pilates equipment such as reformers, Cadillacs, trapeze machines, ladder barrels, spine correctors, Pilates chairs, and Pilates rings. Force plate measuring devices, force frames, Nordic exercise equipment, jump mats, and all forms of resistance devices and equipment, not limited to various resistance bands. Standard exercise / gym equipment includes manual and electric treadmills, weight-bearing treadmills, ellipticals, rowing machines, upright and recumbent bikes, spin bikes, under-desk bikes, stair masters, steppers, stair climbers, step mills, arc trainers, ski ergometers, arm ergometers, punching bags, rope equipment such as climbing ropes and battle ropes, jump ropes, various resistance bands, and bodyweight training systems such as TRX suspension systems. These may be appropriately modified to be reconfigured as NMT (Natural Mobility Training) devices by incorporating sensing technology that can be operationally connected to computer equipment.

[0167] In other embodiments, a computer vision system can be used to measure joint angles as a substitute for position. For example, the user attaches markers to the joint and proximal and distal parts, and the computer vision system captures the movement of the markers to provide a temporal estimate of the joint angle function. This is the case with the exemplary knee (limb consisting of the knee joint 22, femur 24, and tibia and fibula 26) shown in Figure 2A. In fact, computer vision systems are becoming more sophisticated, and any sensors, devices, and systems capable of determining joint angles and the position of the slide carriage 206 can be used. In yet another embodiment, a digital goniometer or inertial measurement unit (IMU) worn by the user provides real-time information on the position and movement of the exemplary knee joint and associated limb.

[0168] As will be readily apparent to those skilled in the art, the neural control device can take the form of other typical exercise equipment. Accordingly, Figures 9A–9D are Figures 230 showing a cycling machine or exercise bike adapted to perform the functions of a neural control device, with elements similar to those in the prior drawings being denoted by the same reference numerals. Figure 9A is a schematic diagram of a neural control device in the form of a conventional cycling machine or exercise bike 231. This device comprises pedals 232, a seat 233 on which a user can sit, handlebars 234 that the user can use to stabilize their body, and a computer device 235. The pedals 232 drive a shaft to which a resistance element 208 (not shown) and a force sensor 210 (not shown) are attached. These are configured to measure the torque required to rotate the pedal. The variable resistance element 208 may take the form of a friction device, a gear system, an electromechanical system, an electromagnetic system, or other resistance element. Thus, the resistance element 208 and the force sensor 210 are functionally equivalent to a resistance extension device as shown in Figure 8A. In another embodiment, the force sensor 210 is integrated into the pedal 232 or the pedal shaft (the axis on which the pedal body rotates, screwed into or held by the crankshaft). The force sensor consists of a load cell, battery, and wireless communication module (e.g., Bluetooth® or ANT+) as described in PCT / AU2019 / 000078, or examples include the X-power Flat pedal series from SRM (https: / / onlineshop.srm.de / ), the Assioma series from Favero Electronics (https: / / cycling.favero.com / en), and the Garmin Vector series from Garmin (https: / / www.garmin.com). The pedal power meter can be mounted on one or both pedals.

[0169] In one embodiment, the resistive element is an inductive element or electric motor, which provides a constant or variable force when the user pushes the pedal and senses the applied force or the angular velocity of the pedal. In one embodiment, the sensing element is a shaft encoder, which provides positional information and thus indicates the time required for the pedal to rotate by a specific angle. The computer device 235 can be operably connected to other computer devices or cloud computing resources and may include a display device and a program or software module that provides feedback to the user giving instructions or performs any of the other functions shown in the computer device in this disclosure. Furthermore, the computer device 235 may include one or more cameras or imaging sensors as sources configured to capture images or videos of the user using the neural modulator. The neural modulator 231 and its inherent extension device can be operated at a constant angular velocity, a variable and clearly defined angular velocity, in one direction or both directions (forward and backward pedaling), and any combination thereof. Not all groups are able to operate a cycling machine (a stationary exercise bicycle). For example, elderly people may lack the balance ability required to sit in the seat 233. Therefore, as another embodiment of the bicycle-type neural control device, a pedal set unit 236 that can be installed in front of the user's seat may be provided, as shown in Figure 9B. The pedal set type neural control device 236 is functionally equivalent to the main body of the cycling machine 231 and may be operably connected to a computer device 212 via a data cable 214 or a wireless device (not shown). The computer device 212 can be connected to cloud computing resources as needed and can retain all the functions of the neural control device 231 except for the seat, handlebars, and built-in display device.

[0170] Embodiments 231 and 236 of the neural control device have the advantage of being able to incorporate a restraining foot strap, foot slot, or preferably a cleat into the pedal 232. This creates a direct and consistent connection between the user's foot (shoe) and the pedal. This means that the user can push and pull the pedal throughout the entire pedal stroke. The cleat also holds the user's foot in a firm and stable position, providing reliable alignment of the center of the foot through the center of the pedal to which the measurement is applied, and avoiding the need to reposition the user's foot after every few pedal strokes. Such a configuration allows the user to apply the dynamic control of the neural control device in both the downstroke and upstroke of each leg, engaging different muscle groups in the process. In yet another embodiment, force sensing functions are built into one or both pedals 232, and the user's shoe is secured to the pedal 232 using a cleat, so that one or both pedals can measure dynamic forces in both the pushing and pulling phases of the cycle.

[0171] From a single-leg perspective, the complete 360-degree pedal cycle is described below. Starting from the peak of the stroke, the pedal is driven forward and downward (hereinafter referred to as the push power phase). At the bottom of the pedal stroke, the user's foot reaches the lowest point of the cycle, and the leg is in a state of maximum extension. Subsequently, the user begins to lift the foot backward and upward towards the top of the pedal stroke (hereinafter referred to as the gravitational force generation phase). At this time, the leg flexes towards the top of the stroke, and the leg reaches its point of maximum flexion. As will be easily understood by those skilled in the art, at each stage of the pedal cycle, the user is mobilizing slightly different muscle groups. This is particularly noticeable when using cleats or similar foot restraints. Therefore, the neural modulator 231 or 236 can be used one leg at a time to isolate specific muscle groups. Alternatively, the user can operate the neural modulator using only a 180-degree range of motion. In this scenario, starting from the peak of the stroke, the pedal is driven forward and downward. At the bottom of the pedal stroke, the user's foot reaches the lowest point of the cycle, and the leg is in a state of maximum extension. Subsequently, the user begins to lift their feet forward and towards the peak of the pedal stroke. This, too, involves slightly different muscle groups. Furthermore, by subtly changing the user's posture during specific cycling movements (continuous forward, continuous backward, and turning), it is possible to alter the muscle groups involved in each phase of the movement. For example, sitting behind the pedal set device 236, standing directly above the device 236, and squatting directly above the device 236 each involve slightly different muscle groups during a session. Finally, the user can operate the neural control device 231 or 236 to perform continuous forward or backward movements with both feet, or periodic or random turning movements according to the instructions of the control software, during each neural control training session.

[0172] Figure 9C is a schematic diagram of a pedal-set type neural control device 236 showing a circular trajectory 237 of a pedal 232 with a fixed crank arm length 238. Elements similar to those in previous drawings are denoted by the same reference numerals. This illustrates the pedal trajectory in a standard bicycle or cycling machine (a stationary exercise bicycle). In one embodiment, the range of motion of the joint can be increased by changing the length of the crank arm, defined as the distance between the shaft and the pedal. Increasing the crank arm length 238 increases the range of motion of the knee per revolution. The crank arm length can be set to a desired length before exercise. Therefore, during one or more sessions of NMT, the crank arm length can be manually adjusted to a desired length, for example, to gradually increase the range of motion. The adjustable crank arm length 238 can be realized using various mechanical configurations. In one embodiment, the crank arm is provided with multiple openings along the crank arm, and the support is provided with a removable retaining pin that can be received in any of the openings. This allows the crank arm to be adjusted by removing the pin, sliding the crank arm against the support to set the crank arm length 238, and then fixing the crank arm length by reinserting the pin into another opening. The pin can be a spring-loaded pin biased to be pushed into the opening, and can be adjusted by temporarily pushing the pin out of the opening (against the biasing force) using a button mechanism. Another example of a configuration is a two-part arm. The first part has an internal cavity and houses the second part. The second part is slidable relative to the first part and can be fixed in a specified position or any position within a range using a screw fastener or the like. Embodiments can be based on adjustable cranks manufactured by "Hase Bikes (https: / / hasebikes.com / en / special-accessories / )" or "SRM (https: / / onlineshop.srm.de / ergometer / )".In another modification, the crank arm may have multiple pedal receiving openings, so that even if the crank arm itself is of a fixed length or size, the relative distance from the shaft to the pedal (or the distance from the shaft mounting point to the pedal mounting point) is variable. This corresponds to the definition of crank arm length as previously stated. In one embodiment, the crank arm is a triangular plate structure with a bearing mounting point at the apex and multiple openings at the distal end (base) of the plate. A pedal can be inserted into (and held in) any of the openings, and each opening generates a substantially different crank arm length. In another embodiment, the crank arm has multiple pedal receiving openings along its entire length, so that the pedal can be mounted at various distances from the shaft and provide an adjustable crank arm length. Embodiments can be based on products manufactured by "Fouriers (https: / / www.fouriers-bike.com / en / )" or "Trek (https: / / www.trekbikes.com / )".

[0173] Figure 9D is a schematic diagram showing the rotational state of a pedal-set type neural control device 236 with a variable-length crank, with the same reference numerals used for elements similar to those in previous drawings. In this arbitrary illustration, the crank length is maximum when the crank is in the vertical position and minimum when the crank is in the horizontal position. At this time, the pedal traces an elliptical orbit. The length of the crank arm can be dynamically changed between sets of motion or during a particular motion. The orientation of the principal and secondary axes of the ellipse can be adjusted to any phase angle with respect to the orientation shown in Figure 9D. In extreme cases, as the length of the secondary axis of the ellipse approaches zero, the pedal trajectory approaches purely linear motion, approximating the movement of the linear sliding neural control device shown in Figure 8A. The length of the crank arm can be adjusted to form an elliptical orbit with a fixed phase relationship with respect to the coronal plane. The length of the crank arm can be adjusted to form an elliptical orbit with a monotonically increasing or monotonically decreasing phase relationship with respect to the coronal plane, i.e., the principal axis of the ellipse changes its relationship with the coronal plane in a consistent manner with each rotation. The length of the crank arms is adjustable to provide a pedal trajectory other than an ellipse, and can also be adjusted independently between the left and right pedals. It will be apparent to those skilled in the art that the crank arm length modification is equally applicable to the cycling machine 231 or the pedal set type neural control device 236.

[0174] In another embodiment, the pedal-set type neuromodulator 236 can be adapted for upper limb use by replacing the foot pedals 232 with hand grips or other human interfaces, and can be used for upper limb functional recovery, such as rehabilitation after shoulder, elbow, or wrist injuries or surgery. Furthermore, the pedal shaft to which the pedals 232 or hand grips are attached is adjustable in length to accommodate different body types with varying shoulder and pelvic widths. Increasing the length of the shaft or spindle also enables targeted neuromodulatory therapy in a wider range of shoulder and hip abduction. This allows for additional elliptical motion and alters the neuromuscular combination around the joint. Therefore, the length of both the crank arm and the shaft / spindle can be adjusted on only one side, and by moving away from symmetrical pedal motion, neuromuscular adaptation can be further promoted. The pedal-set type neuromodulator 236 can also be provided as a desktop unit and used for upper body rehabilitation while the user sits in front of it.

[0175] In another embodiment, one of the pedals 232 of the nerve modulator 231, or the pedals, grips, or other end effectors of a pedal-set type nerve modulator 236 (collectively referred to as pedals 232 throughout this specification), is operably connected to a computer device 235 or other computer device, the connectivity being provided by either a wireless or wired communication protocol as provided herein, and is hereinafter referred to as the “connected pedal.” The connected pedal 232 is configured to measure its motion parameters over time and to transmit these parameters, including the position of the connected pedal and the forces applied thereto, to at least one computer device. This may involve strain gauges, gyroscopes, inertial sensors, accelerometers, or any combination of other devices or instruments capable of providing a stream of information regarding the position, motion, and / or forces applied thereto of the connected pedal 232. These parameters are transmitted to the computer device for real-time presentation to the user. As will be readily apparent to those skilled in the art, the use of connected pedals (including grips and other end effectors) is assumed throughout this specification.

[0176] Furthermore, the neural modulators 231 and 236 may incorporate wireless devices, including headphone jacks or Bluetooth®, for connecting headphones, earphones, or other audio devices. The audio devices may be adapted to provide the user with instructions, music, or other sounds so that other aspects, including sleep memory activation, can be performed as described throughout this disclosure.

[0177] Figure 10 is a sagittal plane schematic diagram 240 of another extension device having a similar function to the extension device of Figure 9, showing only elements functionally equivalent to the extension device of Figure 9, and elements similar to those in the previous drawings are denoted by the same reference numerals. In terms of "equivalent circuitry," the hip joint 30 and ankle joint 32 are connected via a resistance element 208 and further connected via a rigidly coupled measuring device 210 (e.g., a force measuring device). In this embodiment, this measuring device is connected to a computer device 212 via a wireless protocol 242 (wired connection is also possible). In this configuration, the hip joint 30 is the reference point, and the movement of the knee joint 22 and ankle joint 32 is restricted to within the sagittal plane only. The muscle groups that are mainly activated under these conditions are the gluteal muscles (not shown), quadriceps femoris 42, hamstrings 44, and gastrocnemius 46. In one embodiment, the resistance element 208 in Figure 10 is replaced with a rigid coupling, which prevents the user from extending the leg and makes movement 116 impossible. In this embodiment, static force measurements at fixed joint angles are obtained by applying force to the device. This method allows evaluation of both the user's neuromuscular control and maximum muscle strength at each joint angle by fine-tuning the seat position and the length of the rigid coupling. The force measuring device 210 in Figure 10 is rigidly coupled to the resistance element 208, thereby allowing the force sensing device to measure the force applied by the user to the resistance device at any given time. Figure 11 is a schematic diagram 250 of the force measuring device 252, which includes mounting points 254 and 256, a battery 258, a load cell converter 260, a computer device 262, and a communication device 264. The mounting points can be hooks 254 that can be inserted in series into the force path of the resistance element or other exercise equipment, or holes 256 that allow mounting by bolts or other devices. The power bus 266 supplies power from the battery 258 to the converter 260, the computer device 262, and the communication device 264 that provides data to external devices. The measurement channel 268 allows the computer device 262 to determine the instantaneous force applied to the transducer 260, and the communication bus 270 connects the computer device 262 to the communication device 264. The connection via the bolt hole 256 provides a rigid connection to the force measuring device, enabling the measurement of compressive force 272 or tensile force 274, while the connection via the hook 254 limits the measurement to tensile force 274.The force measuring device 252 may include connections by hook 254 only, bolt hole 256 only, the combination shown in Figure 11, or any combination of other types of mounting devices readily understood by those skilled in the art. The communication device 264 may be a wireless communication device such as Bluetooth®, or any of the wireless or wired communication protocols disclosed herein.

[0178] By measuring these parameters at high resolution, the aim is to more accurately identify maladaptive changes such as undesirable jerks in injured subjects, improve the smoothness of movement, and restore the function of a healthy nervous system. For this purpose, the sensors discussed herein may be configured to measure force, position, and other physical parameters at high resolution with high temporal resolution, such as sampling rates exceeding 100 Hz or 1 kHz.

[0179] Since repetition is beneficial for neuroplasticity, rehabilitation therapy should preferably be performed as independent sets or sessions of exercise, carried out multiple times over several weeks or months, for example, daily, every other day, or once a week during the treatment period. However, large NMT-equipped exercise equipment, as shown in Figure 8 or 9, is not always available to the user. Figure 12 is a sagittal plane schematic 280 of a portable neuromodulator configured for use in an office environment. User 28 is seated in an office chair 282 at an office desk 284 (legs omitted for simplification) on which a computer unit 212 is installed. Continuing with the knee as an example, User 28 places their foot on the extension component 286 of the portable neuromodulator, and extension of the leg causes the extension component 286 to move anterior-posteriorly 288 in the sagittal plane.

[0180] Figure 13A is a schematic diagram 290 of a portable extension device. The portable extension device 292 has wheels 294. In one embodiment, the portable extension device has a wedge-shaped profile and may be further molded to be slightly concave or of a suitable shape. The portable extension device 292 may have one or more indentations 296 to facilitate heel positioning and improve grip, or a shape to accommodate the palm. The extension device 292 may optionally include one or more straps 298 to securely fasten the foot during use. The extension device 292 may optionally include a handle 299 to enable operation by the upper limbs. Figure 13B is a schematic diagram 300 of a portable extension device, in which elements similar to those in the prior drawings are denoted by the same reference numerals. The portable extension device 292 has a plurality of wheels 294, the axles of which are connected to at least one friction device 302 and at least one shaft encoder 304. The friction device 302 is applicable to one or more wheels and is used to impart an adjustable amount of friction to the axle, allowing the user to adjust the force required to move the device. The shaft encoder 304 measures the rotation of the wheels, thereby providing a measurement of the distance the portable extension device has traveled in a given time. The shaft encoder 304 supplies a signal to the transducer 308 via the bus 306. In this case, the transducer 308 is configured to read the output of the shaft encoder, process it further, and transmit the data to an external computer device.

[0181] The portable extension device 286 can be used to treat the knee, quadriceps, and hamstrings, as shown in Figure 12. When the portable extension device 286 is rotated 90 degrees, its movement is in the coronal plane, and the device can be used to treat the hip joint and strengthen the hip rotator muscles. Similarly, the portable extension device 286 can be used on a desk 284 by moving the arms either in the sagittal plane (forward and backward direction) or in the coronal plane (left and right direction). As will be readily apparent to those skilled in the art, the portable extension device 286 can be used in various ways to treat a variety of muscle groups, and these embodiments are envisioned in this disclosure. In addition to use in the office environment shown in Figure 12, the portable extension device 286 can also be used in a home office, at a dining table, in front of a television, in a seated position, a standing position, a prone position, against a wall, or in any other suitable position or location where it can operate without restriction on any desired plane, and these embodiments are envisioned in this disclosure.

[0182] The extension device for motion and force measurement, shown in a simplified equivalent circuit in Figure 10, is only part of an NMT system designed to retrain the afferent-efferent signal mismatch in injured or surgically altered joints such as the knee. Based on the embodiments discussed herein, NMT consists of a specific range of motion and a defined protocol for preparing the brain for neural plasticity. NMT opens up opportunities for excitatory cells to form new neural connections through short-term inhibition of inhibitory functions. This allows the brain to efficiently rewire to recognize new afferent signals from altered joints during motion. NMT creates an environment favorable to neural plasticity, where a series of movements adapt the brain to new expectations arising from altered afferent signals under defined efferent motion commands.

[0183] In the initial stages of learning a motor task, movements are often slow, rigid, and easily disrupted if not carefully controlled. This condition is similar to the physiological phenomenon of arthrogenic muscle inhibition associated with recovery from joint injury or surgical intervention. With repeated practice, the execution of the motor task becomes smoother, limb rigidity decreases, and muscle activity becomes effortless.

[0184] Neuroanatomical structures related to memory are widely distributed throughout the brain. While the motor and somatosensory cortices are important pathways for motor memory, the cerebellum is the region primarily involved in motor learning. Studies of cerebellum-dependent motor tasks demonstrate the critical importance of cortical plasticity in motor learning. The basal ganglia also play a vital role in memory and learning, particularly in stimulus-response relationships and habit formation. Importantly, the connectivity between the basal ganglia and the cerebellum is thought to strengthen over time during motor task learning. Hebb's law states that "repetitive firing alters synaptic connections." This suggests that high levels of stimulation resulting from motor practice trigger repetitive firing in specific motor networks, increasing the efficiency of exciting these networks over time. This helps in the formation of new neural representations within the motor cortex by upregulating neurotrophic factors that can promote the survival of new neural maps formed through skilled motor training. However, mere repetition is insufficient. Functional problems resulting from injury or surgical intervention are primarily treated as muscle weakness. Lack of control is rarely considered. Traditional rehabilitation focuses on repetitive strength training, with quantification of muscle strength being the primary indicator of effectiveness, but these have generally proven ineffective. This embodiment provides a method for creating the preconditions for the emergence of neuroplasticity, thereby retraining the brain to respond to new, altered afferent signals transmitted from joints that have been altered in some way by inflammation, soft tissue injury, surgically modified structures, or other devices.

[0185] As mentioned above, neuromuscular control can be considered as "applying the right force to the right movement at the right time." The degree of neuromuscular control is characterized by the ability to smoothly exert the necessary variable force within a defined range of joint angles (leg extension range 116 in the exemplary equivalent circuit of Figure 10). This is usually determined by measuring the progression of movement under load. Measuring at least one parameter such as position, force, or angle as a function of time, individuals with AMI typically exhibit jerky movements under load. As will be readily apparent to those skilled in the art, differential values ​​of position, such as velocity and acceleration, or combinations thereof, can be used as equivalent parameters and are also substituted (but are not limited to these variables).

[0186] Neuromuscular control is a complex system consisting of feedforward commands, cortical drive, motor neuron signaling, sensory feedback, cerebellar processing, and error correction, combined with spinal reflex feedback pathways. Arthropogenic muscle inhibition is a short circuit in this process, preventing the precise application of appropriate force to the appropriate movement at the appropriate time. This must be resolved in all therapeutic approaches. Embodiments referred to herein as neuromodulatory therapy (NMT) teach methods for preparing neural pathways, presumably originating primarily in the cerebellum, for neuroplasticity, thereby reducing arthropogenic muscle inhibition and enabling functional recovery.

[0187] Embodiments of NMT may utilize a combination of feedback and feedforward mechanisms that are thought to amplify the body's motor learning plasticity and accelerate the reorganization of the body's internal movement model within the environment. Neuromodulatory therapy prepares the body to assimilate afferent joint information into its internal world model after injury or surgical intervention. Synapses between parallel fibers and Purkinje cells are particularly plastic under certain conditions, which is thought to be part of the mechanism that reduces arthrogenic muscle inhibition. Repetition is a prerequisite for strengthening synaptic connections. Therefore, NMT utilizes a series of repetitive movements, and critically important in this process is the combination of feedback and feedforward training. The initial stage begins with feedback training and gradually transitions to feedforward training.

[0188] Neuromodulatory therapy is a system utilizing stretching devices, not limited to those disclosed in Figures 8 to 10. In this method, the user must use the stretching device to reproduce a predetermined pattern of force over time (position, velocity, and other target parameters). In one embodiment, the predetermined pattern is a simple repeating pattern, but more complex repeating patterns or non-repeating patterns can also be used. Referring to the exemplary embodiment in Figure 8A, the predetermined pattern is presented to the user as a visual graph of force versus time by a computer device 212, which the user must reproduce using the stretching device 202. A force measuring device 210 measures the force applied by the user, and this force is transmitted to the computer device 212 and, in this preferred embodiment, presented in real time via a wired communication protocol. The method of presenting the predetermined pattern to the user can be a visual device, auditory device, tactile device, tactile device, or other device utilizing one or more senses. Visual presentation is typically used because it can be easily implemented on the display device of the computer device, but this disclosure is not limited to such visual presentations.

[0189] Figure 14 is a schematic diagram 320 of a computer device 212 to which a sensor 210 of the nerve-controlled stretching device (shown in the embodiment shown in 252 of Figure 11) is connected and information is transmitted. In this embodiment, elements similar to those in the prior drawings are denoted by the same reference numerals. Note that the sensor 210 may measure force, position, angle, or other parameters related to the movement of the target muscle group. The computer device 212 may be a desktop computer, laptop computer, tablet computer, iPad®, embedded computer connected to the stretching device, mobile phone, or other computer device. The computer device 212 includes a processing unit 322, a first output device 324, and a second output device 326. The processing unit 322 comprises at least one processor 328, at least one memory 330, at least one input / output (I / O) controller 332, and at least one graphics processing unit 334, and the processing unit 322 executes software instructions to provide a predetermined pattern presentation to at least one of a plurality of output devices or devices. In this embodiment, the first output device 324 is a visual display device that receives data from the graphics controller 334 via the graphics bus 336 and presents the target force during motion as a function of time. In this embodiment, it is presented graphically as a force-versus-time chart 338. The first output device 324 may be integrated with the processing unit 322 as shown in the figure. Conversely, the first output device 324 may be separated from the processing unit 322 but connected in a way that allows it to operate as a functional unit. The first output device may be an augmented reality (AR) or virtual reality (VR) headset. The computer device 212 may optionally include a second output device 326 that provides a predetermined pattern of audio presentations. The sensor 210 of the neural control stretcher communicates with the input / output controller 332 of the computer device 212 via the communication interface 242.In this embodiment, the communication interface 242 is schematically shown as a wireless communication interface, but as those skilled in the art will understand, such communication channels can be implemented via, but are not limited to, USB, Ethernet, Bluetooth®, BLE, Wi-Fi®, Zigbee®, IrDA, fiber optic links, wireless communication, wired communication, optical communication, and other communication interfaces and protocols. The computer device 212 may further include an external interface 340, which enables connection to other computing resources such as external computers, cloud storage, and processing resources via commonly used interfaces and protocols. This can be implemented via Ethernet, Wi-Fi®, or other suitable interfaces.

[0190] The first output device 324 may also be used to present instructions regarding the exercise or movement to be performed. This may include presenting a video of the required exercise (i.e., a sequence of one or more movements), the start and end times of the evaluation time interval, and other status information (e.g., number of repetitions, session ID). The target force level may be presented as an icon such as a ball, bar, or polygon on a force-time curve, bar graph, or other graphic presentation of a predetermined pattern. The second output device 326 may, alternatively, be used to provide information or instructions to the user. The second output device 326 in Figure 14 may be an acoustic device that indicates the target level by changing the amplitude (sound pressure level), pitch (frequency), or other acoustic characteristics of the sound. A tactile output device (not shown) that controls the amplitude and frequency of tactile feedback may also be available. Output can be provided simultaneously by multiple output devices, including any combination of visual, auditory, and tactile feedback.

[0191] The user is instructed to apply force to a load cell, which is presented as a visual graph of force and time. Similarly, the user may be instructed to apply a predetermined force by an audible signal. The force is represented by an acoustic tone, and the frequency of the acoustic signal indicates the required force level (for example, an increase in frequency or a higher pitch instructs the user to increase the force applied). As will be apparent to those skilled in the art, any number of visual graph presentations, acoustic techniques, haptic feedback, or other forms of instruction / feedback can be applied to instruct the user on the required force level.

[0192] This computer system is further equipped with an external interface and is configured to provide connectivity to other computing resources such as external computers, cloud storage, and processing resources via common interfaces and protocols. In this case, data related to the evaluation of a specific user is uploaded to an external data storage location (e.g., an external database, cloud storage device, or archive format). This allows the system to maintain a long-term record of the specific user's capabilities over time. Data archiving and mining enable the derivation of summary statistics, progress, compliance, and other data for specific patients, specific patient cohorts, or other patient stratified subsets. These summary statistics are applicable to a variety of uses. The capabilities of multiple treatment programs can be statistically analyzed to identify the most effective ones. This process can be applied, for example, to the capability analysis of a specific orthopedic joint replacement surgery. This allows for the evaluation of rehabilitation and long-term longitudinal treatment outcomes of joint replacement surgery. The analysis can also be applied to determine the surgeon's treatment outcomes regarding patient rehabilitation and long-term health outcomes. Furthermore, this analysis can be applied to the creation of life tables for insurance purposes. Therefore, embodiments may include statistical analyses of the short-term and long-term effects of various neuromuscular treatments and rehabilitation programs, and how they interact with injury and surgical outcomes.

[0193] In one embodiment, the target force level changes unpredictably and is presented in a short timeframe prior to the current time. This requires the user to react to what they see rather than predict, preventing them from falling into a rhythm that can compensate for injury. For example, often the movement (e.g., exemplary knee flexion and extension) is repeated several times, and the repeated movement may have unpredictable frequency and / or amplitude variations (e.g., the target parameter for a particular movement within the movement changes). In some embodiments, the user only sees the curve for the range necessary to react immediately to the changing force-time profile. This unpredictability prevents the user from learning and prevents them from falling into a rhythmic pattern. In one embodiment, the target force level is suppressed for a certain period, and the user is presented with the immediate target in the first or current period and the future target level in the subsequent period, with a gap between the two periods. This is a feedforward approach, and the user needs to predict the amount of force to apply during the gap period in order to follow the suppressed or occluded target curve and / or to match the future target level at the end of the gap period.

[0194] In extension exercises such as leg presses, movements that require changes in force and position over time serve as a foundation for creating a "blueprint" of memory movements, promoting skill acquisition and improved motor ability that can be recalled later. In one embodiment, a uniform sine wave with the same amplitude and frequency repeatedly reproduced, used as a target force profile, enables movement of the limbs within a stable and consistent range of motion. By using this movement blueprint as a foundation for motor memory, various movement patterns can be applied to evaluate motor control and adaptability, and the accuracy of reproducibility measurements can be utilized.

[0195] Figure 15A is a schematic diagram 350 of a predetermined pattern presented to the user, with elements similar to those in the previous drawings being denoted by the same reference numerals. The visual display device 324 of Figure 14 presents a function of time graph of a target force that the user needs to reproduce on the extension device. The function of force for past time 352 is shown before present time 354, and the function of force for future time 356 is shown against a limited future time frame 358. The length of this future time frame 358 is adjustable based on the complexity of the movement (or action) and / or the ability to respond to the movement (e.g., due to the degree of disability or fatigue). In one embodiment, the future time frame is between 0.1 seconds and 5 seconds. The future time frame can be changed as the movement is performed. For example, the time frame can be extended as the complexity increases, or extended according to the elapsed time in longer sessions where fatigue may occur. In one embodiment, the presentation is a scrolling presentation, and the force-versus-time curves 352 and 356 are scrolled 360, so that present time 354 remains in a fixed horizontal position on the presentation. Figure 15B is a schematic diagram 370 showing a subsequent time point 354' of the predetermined pattern in Figure 15A. Elements similar to those in the previous drawings are denoted by the same reference numerals. Since time 372 has elapsed since the presentation of the target force shown in Figure 15A, the new current time is given by the equation time(354') = time(354) + time(372). The target force 374 at the new current time 354' (after 354) is presented at the same horizontal position on the screen. Therefore, the target force at the current time moves only along the vertical axis 376 as time progresses and is presented on the screen. The vertical spread of the target force 374 represents the magnitude of the force that the user needs to apply to the extension device at any given time.

[0196] In some embodiments, the target force may allow for predictable fluctuations (i.e., a constant frequency / period) during at least part of a session or exercise. This includes, but is not limited to, a sine wave. Because each user has different abilities and disabilities, in one embodiment, neuromodulatory devices and systems can be used to evaluate (or characterize) neuromuscular control. This includes measuring the user's maximum muscle strength, which is recorded as a maximum muscle strength baseline. The target force can then be varied within a range of 0-100% of the measured maximum muscle strength value, or other ranges as needed. The frequency of the periodic function can be in the range of 0.1-0.5 Hz (period 6.6 seconds-2 seconds). In one embodiment, a frequency of 0.3 Hz is used. Frequencies in this range correspond to typical movement speeds in most joints. Frequencies below 0.1 Hz are too slow, making it difficult for disabled individuals to perform smooth movements and causing them to focus on not moving quickly. They are also atypical of normal joint movement (and therefore may be useful for retraining normal movement). Frequencies above 0.5 Hz represent rapid movements, and patients will likely focus on completing the movement within the allotted time rather than on accuracy (i.e., the speed is too fast for them to cognitively concentrate on accuracy). Frequencies can be pre-set, such as 0.3 Hz, or their capabilities and range can be determined by evaluating frequencies suitable for specific patients. It is also possible to use frequencies outside the 0.1-0.5 Hz range, but evaluation with the patient is desirable. Furthermore, the frequency range for specific joints may differ from the 0.1-0.5 Hz range. This deviation from the default range can also be determined through evaluation tests with the patient.

[0197] Figure 16A is a schematic diagram 380 of a predetermined pattern 382 presented to the user, with elements similar to those in the previous drawings being denoted by the same reference numerals. The visual display device 324 presents the sinusoidal predetermined pattern 382. Point 384 is presented to indicate the actual instantaneous force applied by the user to the extender, as measured by sensor 252. As the sinusoidal target force pattern 382 scrolls to the left on the screen, the target force draws a sinusoid on the vertical axis at current time 354. If the user is exerting the full required force, point 384 also draws a full sinusoid on the axis at current time 354. Point 384 provides the user with real-time feedback on the actual force applied. The user can compare the real-time actual force with the target force (the vertical separation between point 384 and the scroll curve 382) and apply force corrections so that point 384 follows the curve 382 more smoothly and accurately. This is referred to herein as "real-time feedback". As those skilled in the art will understand, other periodic or aperiodic patterns are available. For comparison, a sawtooth target force 386 is shown, which increases and decreases linearly between the extremes of the target force, shown here at different rates of change. The frequency of the periodic or repeating pattern is variable, the rise and fall times of the pattern are variable, and the shape of the curve is variable. Within the scope and intent of this disclosure, an infinite number of variations are possible. However, sinusoidal or similar slowly changing target forces are particularly advantageous, especially at transition points, because a gradual change from increasing force to decreasing force (the change from leg extension to flexion in the embodiment of Figure 10) is difficult to achieve even in a healthy neuromuscular system. Thus, gradual changes in force highlight deficiencies in neuromuscular control.

[0198] In one embodiment of neuromodulation evaluation or therapy, the user attempts to follow a target force curve over a predetermined period (capture period 388), and the neuromodulator records the measured force applied by the user. In the case of the exemplary sine wave shown in Figure 16A, the capture period is approximately 2.75 sine wave periods (or 5.5π radians). In other embodiments, the capture period can be the duration of the exercise (e.g., 10 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds or more). In practice, even in individuals with a healthy neuromuscular system, there will be some deviation from a perfect reproduction of the target force. Figure 16B is a schematic diagram 390 of the results of the capture period 388, with elements similar to those in the previous drawings being denoted by the same reference numerals. After the completion of the capture cycle, the predetermined sine wave pattern 382, ​​along with the measured force 392 applied by the user, is presented on the visual display device 324. In this exemplary diagram, the user lags behind the target force both when increasing and decreasing force, and control is particularly poor at the turning points. Furthermore, there is a tendency to "catch up" with strong, linear strokes rather than gradually increasing or decreasing force. Irregular responses can also be observed near the second peak of the sine wave. A response delay of 394 is particularly pronounced after the first peak of the sine wave, and irregular responses of 396 are observed near the second peak. This is a perfectly normal phenomenon for individuals exhibiting arthrogenic muscle inhibition. When a taut contractile muscle is stretched, eccentric muscle contraction occurs. In this case, the motor unit utilization rate per unit force is lower compared to concentric contraction, which shortens under tension. Therefore, when the primary muscle aims for eccentric control, larger errors are more likely to occur. Abrupt changes of direction at the peak of the curve trigger a chain reaction of concentric movement accompanied by deceleration, a slight pause at the peak, and eccentric movement in the neuromuscular system. This highly sophisticated movement is similar to functional changes of direction on a sports field or a pedestrian's avoidance of a collision with a car.

[0199] Figure 16C is a schematic diagram 400 of the user error that mimics a predetermined sine wave 382 (pattern) during the capture period 388, with elements similar to those in the previous diagram being denoted by the same symbols. The error 402 is calculated as the difference between the target force 382 and the measured force actually applied by the user (indicated by symbol 392 in Figure 16B). The target force 382 is superimposed on Figure 16C for visual consistency reference. The degree of neuromuscular control is characterized by the amplitude and phase of the error 402, and the determination of the error's smoothness. For example, if the error curve 402 changes smoothly and gradually, it can be said that the neuromuscular control is better compared to an error curve that shows irregular fluctuations or abrupt changes in amplitude. By analyzing the sign of the difference, it is possible to determine whether the control deficit is limited to specific muscle or joint movements such as extension and flexion.

[0200] Figure 16D is a schematic diagram 410 of the absolute error 412 (i.e., the coefficient of error 402, though not to the same scale as the error in Figure 16C). In one embodiment, a predetermined threshold error value 414 is used to determine the range of motion 416 in which the user lacks control. Alternatively, the error can be used to evaluate the smoothness of motion, or processed to determine summary indicators that guide further treatment (e.g., modification of the complexity of the movement). This analysis can be used to determine the range of force values, joint angle ranges, user correction frequency, and other parameters of interest in which the error exceeds the threshold. As those skilled in the art will understand, other types of error analysis are useful. In one embodiment, a threshold difference value such as 5% or 10% is set, and the percentage of time during the movement in which the difference is below the difference threshold is calculated and compared to a trigger threshold. This difference measurement is normalized (or transformed) and expressed as a percentage of the error difference: % error = 100% × |target value - measurement value / target value. Next, the percentage of each error difference is compared to a difference threshold (e.g., 10%) to calculate the percentage of time during motion when the error percentage was below the difference threshold as an accuracy measure. This accuracy measure is compared to a trigger threshold (e.g., 90%) to determine whether the motion is smooth and whether to trigger changes such as a gradual increase in complexity. In one embodiment, Fourier analysis of the absolute error signal is performed at a specific frequency threshold. In this case, the irregular operating region 418 is identified as a frequency limit exceedance. In another embodiment, the threshold 414 is obtained by calculating the median, mean, and other central statistics (trimmed mean, robust mean, etc.) of the threshold force value when the error exceeds the threshold. Alternatively, the threshold can be ranked and the 75th percentile (or other percentile) value can be used. Based on the variance of the threshold force value, multiple force or error ranges can be defined. For example, measures of variance of values ​​such as interquartile range or standard deviation can be used to determine whether the threshold should be divided into separate groups (and thus ranges). Error bands can be defined, and the percentage of the error rate that falls within each error band during motion can be calculated. For example, error bands can be defined as follows: green / good = difference < 4.25%, orange / medium = 4.25-7.5%, red / poor ≥ 7.5%.Other ranges can be used, more bands can be used, or two bands (e.g., good / bad) can be defined using a single threshold (e.g., 5% or 10% error). Multiple force ranges of interest can also be identified using clustering techniques or other pattern matching or information science methods. In another embodiment, regions of interest can be identified by analyzing overshoot, undershoot, hysteresis, smoothness, or other parameters of interest, in which case some form of analysis of the error 402 or 412 (or analysis of the actually measured force 392) will exceed a predetermined threshold. Any form of analytical or statistical analysis performed on the raw signal 392, error 402, and absolute error 412 is assumed in this disclosure.

[0201] In another embodiment, the predetermined sinusoidal pattern 382 is a static curve that is always visible in its entirety, and the measuring force 392 applied by the user is drawn as an overlay in real time (the point 384 moves simultaneously in both the vertical and horizontal planes). In yet another embodiment, the user is presented with an error signal 402 instead of two curves, and the user actively controls the error to bring it as close to zero as possible.

[0202] Therefore, the degree of neuromuscular control is characterized and quantified by the methods disclosed herein. Furthermore, the repeated application of a predetermined periodic and cyclical pattern, such as the sine wave in Figure 16A, creates a blueprint of motor memory through real-time feedback. Studies have demonstrated that learning new motor tasks not only alters the sensitivity of fast feedback responses (i.e., reflexes) but also modifies feedforward (i.e., voluntary) motor commands. Thus, embodiments can leverage the interaction of feedback and feedforward motor learning mechanisms to enhance neural plasticity and accelerate motor learning.

[0203] Internal models are established concepts in spontaneous motor function. These models represent a neural map of the afferent environment, allowing voluntary control mechanisms to compensate for the complex mechanical properties of the limbs, sensory feedback with delays and noise, and adapt to changes in the body and environment. Less recognized is the application of internal models to fast feedback responses. When counteracting external disturbances, fast feedback responses must also compensate for similar factors. Modern motor control theories based on optimal feedback control also propose that motor behavior is achieved through sophisticated manipulation of sensory feedback. In this type of model, arthrogenic muscle inhibition naturally limits control and recovery from injury or surgical intervention. Because sensory information does not match the model of joint movement, inhibition shuts down the system as a protective mechanism. However, this type of model suggests that bidirectional transfer between feedforward and feedback control is expected, as feedforward motor commands and transcortical feedback responses are part of the same control system implemented in common neural circuits. The cerebellum, closely interconnected with the primary motor cortex, has long been hypothesized to be strongly involved in multi-joint coordination in both feedforward control and feedback responses, and to be responsible for computations related to internal models.

[0204] Therefore, this embodiment teaches a method that leverages the duality of feedback and feedforward motor learning. Real-time feedback is described as a mechanism for motor skill learning, and in one embodiment, the user needs to apply a predetermined sinusoidal pattern of force to a neuromuscular stretcher in synchronization with a predetermined pattern of force. Feedforward motor learning is achieved by suppressing a portion of the predetermined pattern, recalling the motor blueprint learned by the user (learned during real-time feedback), and forcing "gap filling" using a combination of feedback and feedforward control mechanisms when applying it to a known gap in the predetermined pattern. Hereafter, this will be referred to as "real-time feedforward." Feedback can be considered a type of calibration, allowing the user to see (i.e., observe) the results of their efforts directly in real time and learn the amount of effort required to match the target parameter, or how to adjust the effort. This prepares the user for the feedforward session. In the feedforward session, the user must predict the amount of effort required to achieve the indicated target value at a future point in time, for example, by suppressing or occluding the curve of the target parameter, or by occluding the measured values ​​of a portion of the movement (measurement or capture period).

[0205] By gradually increasing inhibition, users become more reliant on estimating motor skills and mastering gap-filling movements, and consequently, on feedforward capabilities. Because feedback and feedforward work in conjunction, the transition from high feedback, low feedforward to low feedback, high feedforward facilitates a focus on processing prediction errors. While this disclosure demonstrates the significant advantages of transitioning from feedback dominance to feedforward dominance, this does not have to occur in a monotonic order. Therefore, this embodiment demonstrates that various combinations of feedback dominance and feedforward dominance are advantageous. Accordingly, the embodiment discloses a method called NMT, which leverages both real-time feedback and real-time feedforward motor learning. NMT creates a highly neurally plastic environment, enabling rapid learning of internal models. This is particularly advantageous in the afferent information environment of a new normal state following injury or surgical intervention.

[0206] Changes in curve suppression can evaluate different aspects of motor skills. For example, shielding a nearly linear section of a sinusoidal wave where inertia has already occurred can be considered a simple gap-filling task. In the example using the leg press extension device shown in Figure 10, suppressing (shielding) the rising portion of the sinusoidal wave involves a gradual increase in force over time and uses concentric muscle contraction. On the other hand, suppressing (shielding) the descending portion of the sinusoidal wave involves a gradual decrease in force over time and uses a different type of eccentric muscle contraction. It is widely known that eccentric muscle contraction uses fewer motor units per unit time compared to concentric muscle contraction. Therefore, in eccentric muscle groups, a larger force is exerted per motor unit, increasing the load per unit and resulting in fatigue. In contrast, maintaining neuromuscular control while suppressing (shielding) the turning point of the sinusoidal wave is a much more complex task involving a change of direction. Based on memory of occlusion patterns, subjects need to perform predictive deceleration towards an instantaneous isometric state (stationary position) followed by an acceleration task, all within a short timeframe. The timing of this transition in the transition zone drastically alters muscle contraction. Specifically, it involves a transition from eccentric muscle contraction to instantaneous static isometric contraction and then to concentric muscle contraction, or vice versa. When the amount of presented curve information decreases due to suppression (occlusion) or reduction of the presentation range, subjects need to increase their reliance on feedforward mechanisms to enhance their predictive ability. Injured subjects have a greater visual and cognitive processing load than uninjured individuals, making visual information occlusion a significant challenge to their maladaptive systems, especially under real-time constraints. An unpublished study confirmed that athletes with ACL injuries showed higher error scores on the injured side and lower performance on the injured side when visual curves were occluded. Fatigue affects the smoothness of movement and contributes to increased errors. Fatigue can also affect the excitability / inhibitory balance, potentially reducing cortical drive and subsequent motor unit output. Curve occlusion and its progression are important parameters in developing appropriate treatment plans for specific joints and muscle groups in particular patients. Decision-making on complex tasks like point occlusion is more cognitively demanding than simpler tasks. Fatigue levels increase with longer testing periods, either over a specific cycle or multiple cycles, which can affect measurement errors.Repeating tests without sufficient rest periods not only causes localized muscle fatigue but also puts a strain on the central nervous system, including (but not limited to) cognitive load.

[0207] Figure 17 is a schematic diagram 430 showing a series of visual presentations of feedforward motion according to one embodiment, where the target parameter is a sinusoidally changing target force, presented on a visual display device 324. In each visual presentation, different regions of the force pattern are occluded. Point 384 represents the instantaneous force applied by the user to the extension device in real time and moves only along the vertical axis 432. The current time is presented near the left end of the graph, and a long future time frame is visualized. The series of visual presentations includes a frame 434 with 25% occluding in the center, a frame 436 with 50% occluding in the center, a frame 438 with 75% occluding in the center, 25% occluding at the turning point 440 (12.5% ​​from both ends), and 50% occluding at the turning point 442. In another embodiment, the target force presentation can be provided audibly, presenting the change in target force using amplitude, pitch, or other parameters. This method is also applicable to the presentation of suppression, which is indicated by silence, a constant, unique sound, or other sound identifiable within a fluctuating acoustic environment (i.e., to suppress the presentation of the target level). In one embodiment using visual, auditory, tactile, or any combination of feedback, suppression can be performed for one or two types of feedback while provision continues for another type. For example, even if a visual curve is suppressed (or occluded), the provision of auditory and / or tactile feedback can continue.

[0208] Figure 18 is a schematic diagram 450 showing a series of visual presentations of another predetermined target force pattern that changes sinusoidally, presented on a visual display device 324 according to one embodiment, in which different regions of the pattern are occluded in each visual presentation. The first plot constitutes random occlusion 452, and the second plot constitutes a small future time frame 454, which can be a very short fixed or variable period. Shortening the future time frame reduces the amount of visual information that needs to be processed, thus reducing the cognitive load. Neuromodulatory therapy employs a method of starting with a full sinusoidal wave (continuing in this preferred embodiment) for real-time feedback training, and then moving to real-time feedforward while gradually expanding the occlusion frame. As treatment progresses, it may be appropriate to completely suppress or occlude the sinusoidal wave 456, as shown in the third plot. In this plot, only points 384 representing the force applied by the user are presented (i.e., the presentation of the target parameter is completely suppressed while maintaining the feedback presentation). After a period of training, it is found that users can reproduce sine waves with remarkable accuracy in both amplitude and frequency, even when the sine wave is completely suppressed or shielded, and only point 384 is provided as feedback. Finally, as shown in the final plot, it is also possible to suppress or shield both sine wave 458 and point 384. For reference, the unshielded sine wave 382 is shown in Figure 16A.

[0209] Error analysis of the parameter difference between measured values ​​and target values ​​can be used to determine changes or progression in treatment. For example, it can be used to determine the timing of introducing inhibition (shielding) or changing (e.g., increasing) inhibition parameters such as inhibition parameters (inhibition rate: e.g., 10%, 25%, 50%, 75%) and position (e.g., phase angle range). In one embodiment, one or more thresholds and / or one or more error ranges (or error bands) can be defined, and the percentage of time during exercise in which the differential error is above / below the threshold and / or the percentage within each error band can be calculated. For example, a single threshold error level such as 10% can be defined, and good and bad error bands can be set (0-10%=good > 10%=bad). Similarly, two thresholds can be defined to create three error ranges or error bands, which can be labeled as good, intermediate, bad, or green, orange, and red (traffic light indication). In one embodiment, the error thresholds are 4.25% and 7.5%, but other thresholds such as 5% and 10%, or 10% and 25% can also be used. It is also possible to define 4, 5, or 6 error bands using additional thresholds (e.g., 3, 4, or 5 thresholds). Complexity changes can be automated. In one embodiment, transitions are based on local mean values, stability metrics, or variance reduction metrics. For example, the amount of variation over time in one or more error bands, such as a good or minimum error band, is calculated over the past n trials (e.g., n=3, 4, 5, 6). If this variation is small (<5% or <10%), it suggests the patient is not being overloaded by the motor task, and complexity progression may be triggered. Similarly, if the increase in the red / poor range is stable, it suggests the patient is unable to adapt to the increasing complexity or is fatigued, and complexity reduction may be triggered. Alternatively, more complex criteria, such as significant changes in the time variability within a specific error band, can be combined with the amount of variation to trigger changes. By programming appropriate trigger rules into the control device (computer), the triggering of inhibition level changes during a session can be controlled, further automating the treatment. In one embodiment, a predetermined progression of inhibition levels can be programmed for one or more sessions, and changes can be made in real time according to saved trigger rules that take the user's capabilities into account.

[0210] By manipulating other aspects of the target force pattern, changes in neuromuscular control levels can be measured. In one embodiment, partial occlusion of the entire curve can be achieved by changing the transparency of the curve on the screen or by adjusting the contrast between the curve and the background. In another embodiment, the entire visual presentation of the target force can take the form of "flashing" occlusion, where it is alternately made visible and invisible at various frequencies and / or duty cycles. In yet another embodiment, the method of presenting points 384, which represent the force applied by the user in real time, can be changed. Points 384 can be visually presented / hidden, or presented by changing their transparency or contrast with the background. The cognitive load can be increased by increasing or decreasing the frequency of repeating target force patterns. Higher frequencies increase the cognitive load and place a burden on injured users. Injured users require a greater cognitive load because their autonomic nervous system function is reduced compared to uninjured users. At higher frequencies, steeper curves intensify the emphasis on complex skills requiring rapid changes of direction, further increasing the burden on the user. The direction in which the curve moves on the screen can affect the user's ability to accurately reproduce the target force. The curve can move from left to right, right to left, top to bottom, or bottom to top. An ideal curve can also be represented by a Lissajous figure, where the target force is on the horizontal axis and the force applied by the user is on the vertical axis (or vice versa). A circle is an example of a Lissajous figure with parameters a=1, b=1, and phase=π / 2, while a straight line tilted 45 degrees to the horizontal is a Lissajous figure with parameters a=1, b=1, and phase=0. The curve can be drawn on the screen or moved within a simulated 3D space through virtual reality (VR) presentation.

[0211] Figure 16C illustrates a method for evaluating the error 402, which is the difference between the target force 382 and the force 392 applied by the user. It then discusses how different types of errors 416 and 418 are associated with different exemplary user force-applying error profiles 394 and 396, respectively. The error distribution, error form (including overshoot and undershoot), error amplitude, phase relationship of the error with respect to the target force, frequency components, and other error characteristics provide clinicians with information applicable to optimizing NMT and improving functional therapy design. Software applications embedded in NMT devices and systems present the error to the user (and / or clinicians, where appropriate throughout this specification). As shown in Figure 16B, it may be beneficial to present the measured force overlaid on the target force. It may also be beneficial to observe the effort, for example, when the error is presented as a percentage of the target force or other parameters, as illustrated in Figures 16C and 16D. Other error presentation formats are readily conceivable to those skilled in the art and are also conceived in this disclosure.

[0212] Errors can also be categorized into range bands to allow for rapid tracking of post-test progress in terms of both error values ​​and target force profile intervals. Exemplary error bands are represented by categories such as "good," "average," and "poor," which may include color coding such as green, orange, and red, although other categories may be more appropriate depending on the context. Error distributions can be adjusted according to the type of target population. For example, athletes with high levels of motor skill may require stricter tolerances for these error bands than the general population or patients undergoing early rehabilitation after injury or surgery. In an unpublished athlete population study conducted by the inventors, the green band (0%–4.25%), orange band (4.26%–7.50%), and red band (>7.50%) were used. This classification helps users maintain motivation for error improvement and ultimately increase the amount and intensity of NMT. ​​Error ranges and the percentage of time within each range can be used to determine when to trigger changes in suppression, such as increasing the complexity of suppression. An increase in error can also be used as a trigger to decrease complexity. Other error ranges are also available, including two-stage (good / poor) ranges using a single threshold (e.g., 2.5%, 4.25%, 5%, 10%, 20%, 25%), and ranges with three or more stages. Evaluation or calibration experiments can be performed on a specific joint to determine an appropriate threshold for that joint.

[0213] This embodiment demonstrates that inhibition (occlusion) increases reliance on prediction and feedforward mechanisms. By comparing error profiles with and without occlusion, insights into the subjects' feedforward and feedback mechanisms can be obtained. Subjects with injuries show increased reliance on areas such as the cerebellum that assist in predicting and reducing errors in motor tasks. Therefore, occlusion with feedforward mechanisms provides insights into the cerebellum. In an unpublished study, subjects with injuries performed worse than healthy controls in a transition point occlusion test.

[0214] Physiologically, there are differences in muscle behavior during concentric (shortening) and eccentric (lengthening) muscle contractions. Eccentric muscle contractions use fewer motor units per unit force, and therefore the load on each activated motor unit is higher. This causes rapid fatigue of motor units, which is particularly pronounced in subjects exhibiting arthrogenic muscle inhibition. Furthermore, our own unpublished research has confirmed that patients who have undergone anterior cruciate ligament reconstruction and total knee arthroplasty have difficulty with the "release" movement (eccentric contraction) of the quadriceps and hamstring muscles, leading to decreased control during deceleration.

[0215] Dividing the exemplary sinusoidal target force into four quadrants provides further insights beyond concentric and eccentric muscle contractions. Figure 19 is a schematic diagram of the four quadrants. Quadrant 1 (462) represents concentric contraction at low force. Quadrant 2 (464) represents concentric contraction at high force. Quadrant 3 (466) represents eccentric contraction at high force. Quadrant 4 (468) represents eccentric contraction at low load. By classifying the entire extension and flexion cycle using this quadrant approach, a method can be obtained to correlate the force range with the number of motor units recruited. For example, Quadrant 3 (466) represents high-load eccentric contraction, and because arthrogenic muscle inhibition reduces the number of available motor units, fatigue is likely to occur earlier than in low-load concentric contraction in Quadrant 1 (462). Classifying error analysis using this quadrant model can provide insights into the design and progression of NMT and rehabilitation. If the error is too large, the effects of increased cortical drive and the resulting decrease in intracortical inhibition may be limited. Therefore, this embodiment provides a method for characterizing errors using quadrant division. However, as will be easily understood by those skilled in the art, other methods of dividing errors are also envisioned within the scope of this disclosure.

[0216] By utilizing the results of four-quadrant analysis for advancements and improvements in neuromodulatory therapy, targeted treatment of neuromuscular control disorders in users becomes possible. Our research revealed that patients who underwent total knee arthroplasty experienced greater errors in the low-load, eccentric contraction quadrant 468 compared to the low-load, concentric contraction quadrant 462. This is consistent with the fact that, as widely reported in the literature, the co-contraction state of both the quadriceps and hamstring muscles makes it difficult for patients to release force in a controlled manner. Specifically, spending more time training in this quadrant using neuromodulatory therapy provides a pathway to improve patients' ability to perform controlled "release." Therefore, improvement in error scores allows for a focus on functional deficits, enabling patients who have undergone total knee arthroplasty to improve their functional state during activities such as walking. After neuromodulatory therapy, patients who have undergone total knee arthroplasty have been shown to immediately (without prompting) improve the functional quality of walking, reduce limping, exhibit limb movements during walking that mimic the non-operated leg, and result in more optimized bipedal gait. Similarly, quadrant 466, which shows high eccentric muscle contraction and an overall increase in error due to fatigue, indicates that patients who have undergone total knee arthroplasty have difficulty descending stairs using eccentric muscle contraction and are at high risk of falling. However, NMT targeting quadrant 466 can improve fatigue and delay the onset of fatigue, thereby reducing the likelihood of falling. Referring to the modified exercise bike of the neural control device 231 shown in Figure 9A, the predetermined sinusoidal pattern shown in Figure 19 can be reproduced by pedaling forward along the curve in quadrants 462 and 464, and by pedaling backward in quadrants 466 and 468. In this case, the pedaling speed corresponds to the rate of change of the gradient of the predetermined pattern. Other modifications of this method will be readily apparent to those skilled in the art and are also envisioned in this disclosure.

[0217] In one embodiment of neuromodulatory therapy (NMT), a progression from feedback to feedforward motor learning is used to learn a new signal environment and improve motor control. Figure 20 is a schematic diagram 470 of the progression of treatment time in one embodiment of neuromodulatory therapy. The treatment begins with real-time feedback motor learning 474 (feedback movement) only. Using a predetermined pattern of exemplary sine waves, the user goes through multiple cycles of capture period 388 in which an unoccluded target force curve 382, ​​as shown in Figure 16A, is presented. Analysis of the error 402 or absolute error 412, as shown in Figures 16C and 16D, determines when the user is ready to proceed to the next stage of treatment (i.e., introduction of occlusion of part or all of the target force curve 382). In this embodiment, this occlusion is referred to as visual occlusion, or simply occlusion (i.e., references to occlusion in this specification should be understood to refer more generally to occlusion). The treatment may progress to a stage that includes a small amount of occlusion 478. In one embodiment, the user experiences multiple motion cycles during the capture period in which a slightly occluded target force curve is presented, such as a small frame 434 with the central portion occluded, as shown in the upper plot of Figure 17. The occlusion of the central portion makes it easier for the user to fill in the gap than occlusion at a turning point, because it only requires the continuation of the existing motion rather than predicting a change of direction.

[0218] As the user is ready to progress, the treatment progresses from 478 to 480 (see Figure 17), gradually expanding the central occlusion frame from 436 to 438 to increase the real-time feedforward contribution to motor learning. As motor control improves, the treatment progresses to occlusion of turning points. It starts with minimal occlusion of turning points 440 (e.g., 5%, 10%, 20%, 30%, 40%, 50%), as shown in Figure 17. This becomes a significantly more difficult task for the user because it requires precise control of deceleration, accurate timing management of turning points, and precise control of acceleration in the reverse direction to reach the appropriate position (force, position, and other parameters) on the curve at the moment the curve is released from the occlusion state. Again, as motor control improves, the treatment increases the occlusion frame at turning point 442 (e.g., 10%, 20%, 30%, 40%), as shown in Figure 17. This continues until the curve is almost completely occluded (e.g., 90%, 95%, 99%, not shown). Thus, the treatment timeline progresses alternately between 478 (or 474) and 480 in the middle of the treatment period, moving from minimum central occlusion to maximum central occlusion, and from minimum turning point occlusion to maximum turning point occlusion. However, as the difficulty of occlusion increases, a shift in emphasis from real-time feedback 478 to real-time feedforward 480 is common. That is, NMT consists of a series of sessions, each session containing multiple movements. Over time, the multiple movements within a session shift from primarily or entirely (e.g., at least 80%) feedback movements to primarily or entirely (e.g., at least 80%) feedforward movements, and the amount of occlusion and complexity of occlusion in the feedforward movements also increase over time. Complexity refers to aspects such as the difficulty and cognitive load in performing the movements, including predicting the time and effort required to match the target force curve. In one embodiment, the user may be instructed to perform a cognitive task while performing the movements described herein. Instructions may be given verbally or visually, such as tasks presented on a screen.

[0219] As neuromuscular control improves with the course of treatment, the user may no longer be presented with a predetermined pattern to follow (i.e., complete or 100% occlusion). At this stage, the user relies almost entirely on motor memory for the amplitude and frequency of movement (e.g., the sequence of actions in the movement). At this stage, feedback presentations regarding the measured force, position, and other parameters applied by the user are still provided, but because there is no predetermined pattern to follow, the user is in a state of complete real-time feedforward. The treatment progresses further, the measured force feedback is removed, and the user is presented with a completely blank screen 458, noticing the absence of point 384. This is complete real-time feedforward 476. This illustrates the interaction between real-time feedback and real-time feedforward motor learning in the neuromodulatory therapy disclosed herein.

[0220] In one embodiment, NMT consists of multiple sessions spanning a period of time (several hours, days, weeks, months, or more), with each session potentially beginning with multiple cycles of an unblocked pattern (i.e., feedback movement). Introducing a short period of feedback motor learning at the start of a session refreshes the neural memory system, facilitates interaction between the feedback and feedforward motor systems, and improves the rate of motor learning. Specifically, each session may consist of one to several sets of feedback movements followed by numerous feedforward movement sets, or it may be structured with feedback sets interspersed between numerous feedforward sets. Control assessments and related reports can be provided at the end of each movement, at the end of each movement set, or at the end of the session.

[0221] The effect of NMT lies in the updating of the internal model of motor function based on new, normal afferent information, thereby reducing the effects of arthrogenic muscle inhibition. Because the motor response in the altered joint aligns with the newly updated internal model, the need for inhibitory protection is eliminated, and controllability improves. Neuromodulation therapy is thought to create a timeframe in which motor learning function is in a state of high neural plasticity. Fine-tuning of the internal model becomes possible when sensory experiences are mapped to known or planned motor functions. In other words, neural pathways are prepared for an optimal learning state. Remarkably, this timeframe opens with just a few minutes of neuromodulation therapy and lasts for several hours. In unpublished research, the inventors discovered that this timeframe was extended by several days after a single session of targeted neuromodulation therapy. This means that rapid effects can be...

Claims

1. A method for providing neuromodulatory therapy (NMT), A step of instructing and / or using a device to instruct a user to perform a plurality of movements, the plurality of movements including one or more feedforward movements, A step of providing the user with the presentation of one or more target parameters for at least one of the plurality of movements, wherein at least one of the plurality of movements includes one or more feedforward movements, the presentation of the target parameters is provided over one or more presentation periods during the performance of each movement, and the presentation of the target parameters during the performance of the feedforward movements is shielded for at least a portion of the presentation period; The steps include measuring one or more target parameters over one or more capture periods while the user is performing at least one of the multiple exercises, A method comprising the step of providing feedback to the user using the one or more target parameters that have been measured.

2. The method according to claim 1, The user is instructed to attempt to match the one or more target parameters in real time during the one or more presentation periods. Each of the aforementioned movements includes one or more actions. A method in which each of the aforementioned presentation periods is a period for performing at least one complete operation.

3. A method according to claim 1 or 2, At least one of the aforementioned plurality of movements further includes at least one feedback movement, The presentation of the target parameter during the performance of the feedback motion is provided over the entire duration of the presentation period.

4. A method according to any one of claims 1 to 3, A method comprising the step of evaluating the neuromuscular control of at least one target musculoskeletal joint during the performance of at least one of the plurality of exercises, further comprising the step of determining one or more differences between one or more target parameters and their measured values ​​during one or more capture periods.

5. The method according to claim 4, A method wherein the evaluation is used to trigger a change in the occlusion of the presentation of the target parameter during a portion of the one or more presentation periods while the feedforward motion is being performed, the evaluation is used to change the phase, duration, or complexity of the occlusion of the presentation of the target parameter.

6. The method according to claim 5, The evaluation includes determining one or more accuracy measurements using the one or more differences, A method wherein one or more accuracy measurements are compared with one or more predetermined trigger thresholds to trigger a phase change that obscures the presentation of the target parameter during one or more presentation periods.

7. The method according to claim 6, The aforementioned difference of 1 or more is compared with one of the one or more predetermined difference thresholds. The accuracy measurement values ​​of 1 or more mentioned above are estimates of the proportion of time during the performance of each exercise in which the difference of 1 or more mentioned above falls within a difference range of 1 or more. A method in which the one or more difference ranges are defined by the one or more difference thresholds.

8. The method according to any one of claims 4 to 6, A method further comprising the step of electronically reporting the evaluation of neuromuscular control of at least one target musculoskeletal joint.

9. A method for evaluating neuromuscular control of at least one target musculoskeletal joint, The steps include instructing the user to perform one or more movements, and / or using a device to instruct the user to perform one or more movements, including movement of at least one target musculoskeletal joint, A step of providing the user with the presentation of one or more target parameters for at least one of the one or more movements over one or more presentation periods, wherein the user is instructed to attempt to match the one or more target parameters in real time, The steps include measuring the one or more target parameters as a function of time over one or more capture periods while the user is performing the one or more exercises, The steps include determining the difference of one or more between the one or more target parameters and their measured values ​​during the one or more capture periods, A method comprising the steps of creating an assessment of the neuromuscular control of at least one target musculoskeletal joint using the differences of one or more of the above, and electronically reporting the assessment created.

10. A method according to any one of claims 4 to 9, The evaluation method further comprises determining one or more of the following using the one or more differences: a measure of smoothness of motion, an error summary, and a control summary, including one or more ranges of the one or more target parameters and / or one or more joint angle ranges of the user, in the case where the user lacks control of the musculoskeletal joint of the at least one target.

11. The method according to claim 10, The step of determining the one or more differences is, This includes calculating one or more measurement errors by comparing one or more target parameters with their measured values ​​over the aforementioned one or more capture periods, The method further includes the step of performing a statistical analysis of the one or more measurement errors to characterize the locations where the user lacks control of the at least one target musculoskeletal joint.

12. A method according to any one of claims 1 to 8, 10, or 11, The aforementioned multiple exercises are divided into multiple sessions. Each of the sessions comprises one or more sets of one or more exercises.

13. The method according to claim 12, At least 80% of the exercises included in the session are transitioned from feedback exercises to feedforward exercises over time. A method for increasing over time the amount and complexity of the shielding that obscures the presentation of the target parameter during the execution of the feedforward motion.

14. The method according to claim 13, The amount and complexity of the shielding increase until the presentation of the target parameter is 100% shielded. During the performance of each of the aforementioned exercises, only feedback using the measured target parameters will be presented. During the subsequent execution of each of the aforementioned exercises, the presentation of the feedback will also be blocked. method.

15. The method according to claim 14, The aforementioned target parameter is a sinusoidal curve of force that has a curve period and changes sinusoidally. Increasing the amount and complexity of the shielding that obscures the presentation of the target parameters during the execution of the feedforward motion over time is: The process begins by shielding the central portion of the sine curve for a first period of less than 20% of the curve period. Next, the first period is extended, Next, the inflection point of the sine curve is shielded, A method comprising, next, gradually increasing the percentage of the period of the curve that is shielded until the sinusoidal curve is 100% shielded.

16. A method according to any one of claims 13 to 15, A method for increasing the complexity that obscures the presentation of the target parameter, comprising selecting a portion of the sine curve that passes through the inflection point, and increasing the cognitive load on the user.

17. A method according to any one of claims 12 to 16, In the case of a dependency on claim 4, During the reference session, neuromuscular control is evaluated according to claim 4. The evaluation includes determining one or more ranges of the target parameter and / or one or more joint angle ranges of the user at locations where the user lacks control of the musculoskeletal joint of the at least one target, A method in which, in a subsequent session, one or more sets of one or more exercises instructed by the user to perform or instructed by the device are selected using one or more ranges of the target parameter and / or one or more joint angle ranges of the user at the location where the user lacks control of the at least one target musculoskeletal joint, as determined in the evaluation.

18. A method according to any one of claims 12 to 17, In the case of a dependency on claim 4, The step of performing the evaluation of neuromuscular control of the at least one target musculoskeletal joint according to claim 4 is: A method to evaluate one or more of the following in a reference session and one or more subsequent sessions: the progress of treatment, the progress of treatment for arthrogenic muscle shielding (AMI), the progress of the rehabilitation program, the progress of the development program, the progress of the ability optimization program, a measure of the progression of neurological disorders, whether or not the user suffers from mild cognitive impairment, the progress of treatment for improving balance function, and the progress of treatment related to neuroimmunological status.

19. The method according to claim 18, The evaluation in the subsequent session is a method that at least includes comparing the one or more differences determined in the subsequent session with the one or more differences determined in the reference session.

20. The method according to claim 18 or 19, At least one set of exercises during the session is made more difficult than other sets of exercises during the same session in order to impose a higher cognitive load on the user. A method for evaluating whether the user suffers from mild cognitive impairment, based on the difference obtained when the user is subjected to a higher cognitive load.

21. A method according to any one of claims 1 to 20, Each of the aforementioned movements includes one or more actions, Each of the above operations is, A dynamic motion which involves moving one or more muscles associated with the musculoskeletal joint of the at least one target to move the musculoskeletal joint of the at least one target over a range of joint angles, or A method comprising a static movement, which includes moving one or more muscles associated with the musculoskeletal joint of the at least one target while holding the musculoskeletal joint of the at least one target in a resting position at a fixed joint angle.

22. A method according to any one of claims 1 to 21, A method wherein the target parameter changes over at least one of the one or more presentation periods.

23. A method according to claim 22, A method further comprising the step of providing the aforementioned target parameters as a function of time.

24. The method according to claim 23, A method wherein the presentation of the target parameter is a visual presentation on a display device.

25. The method according to claim 24, A method for presenting the target parameter, wherein the presentation of the target parameter is a chart comparison between the target parameter and its measured value, or a presentation of the instantaneous difference between the target parameter and its measured value.

26. A method according to any one of claims 1 to 25, The aforementioned target parameters change predictably in one or more movements. A method wherein the presentation of the target parameter is shielded for one or more shielding periods during one or more presentation periods.

27. The method according to claim 26, The above-mentioned exercise 1 or more includes multiple exercises, A method in which the presentation of the target parameters for each sequential movement in the plurality of movements is obscured according to a series of occlusions.

28. The method according to claim 27, Each shielding in the series of shielding methods has a different shielding period from one another.

29. A method according to claim 27 or 28, A method wherein each shielding in the series of shieldings is characterized by a progressively longer shielding period or a progressively increasing complexity of shielding.

30. A method according to any one of claims 1 to 29, The presentation of the target parameter during the performance of at least one of the aforementioned multiple movements is an unpredictably changing visual presentation. The method for presenting the target parameters is to present them within a short time frame prior to the current time.

31. The method according to claim 30, The presentation of the target parameters in the first group of one or more sets of the one or more movements is an unpredictably changing visual presentation, where the target force level is presented in a short time frame prior to the current time. The presentation of the target parameter in a subsequent group of one or more sets of the one or more movements is a predictably changing visual presentation and / or is shown over a long time frame prior to the current time.

32. A method according to any one of claims 1 to 31, The feedback presentation method includes the real-time presentation of measured values ​​of the target parameter.

33. A method according to any one of claims 1 to 32, The method further includes a preliminary step of measuring the maximum achievable threshold value for each of the one or more target parameters mentioned above, A method wherein each of the one or more target parameters varies as a percentage of the measured maximum achievable reference value.

34. A method according to any one of claims 1 to 33, The step of instructing the user further includes playing one or both of the audible sequence and the tactile sequence while the user is performing the movement, This method is A method further comprising the step of playing one or both of the audible sequence and the tactile sequence when the user is not engaged in a cognitively demanding task.

35. The method according to claim 34, A method wherein the playback of one or both of the audible sequence and the tactile sequence is performed while the user is asleep.

36. A method according to any one of claims 1 to 35, One or more of the aforementioned multiple exercises are performed by the user using a neuromodulatory therapy device having a resistance element and a sensing device configured to measure one or more target parameters as a function of time over one or more capture periods while the user performs the one or more exercises. A method comprising a computer device capable of communicating with the sensing device that provides measurements of one or more target parameters, wherein the steps of instructing the user, providing the target parameters, providing feedback, determining one or more differences, and, if dependent on claim 8 or 9, preparing and electronically reporting the evaluation are performed.

37. The method according to claim 36, The computer device is a mobile computer device that includes a display device configured to display the one or more target parameters as a function of time, A method comprising: a mobile computer device configured to receive the measured values ​​from the sensing device in real time and to display the feedback display using the display device.

38. The method according to claim 36 or 37, The aforementioned target parameter is force, A method wherein the force is measured by one or more load cells connected to the resistive element.

39. The method according to claim 38, The force is measured by one or more portable load cells. A method comprising one or more portable load cells configured to wirelessly transmit measured force data to the computer device, and comprising a mounting mechanism for attaching one end of the resistance element to a mounting portion on the nerve conditioning therapy device.

40. A method according to any one of claims 36 to 39, The computer device is further configured to upload data to an external data storage location, in a method.

41. A method according to any one of claims 36 to 40, The method includes a sensing device comprising a computer vision system configured to capture and measure the joint angles of the user during the performance of the movement.

42. A method according to any one of claims 36 to 41, The method includes a sensing device which includes a digital goniometer configured to measure the joint angles of the user when the user is wearing it.

43. A method according to any one of claims 36 to 42, The sensing device comprises a force sensor, an inertial measurement unit (IMU), and a communication module. The method is configured such that the communication module wirelessly transmits force data and posture data measured by the force sensor and the inertial measuring unit (IMU) to the computer device in order to estimate the force applied by the user and the user's joint angles as a function of time during the performance of the movement.

44. A method according to any one of claims 1 to 43, The step of using the device to instruct the user includes attaching the end effector of a collaborative robot (cobot) to the user. The end effector includes a force sensor, The aforementioned collaborative robot is programmed to follow a predetermined path while performing the aforementioned motion. The user is instructed to move one or more muscles associated with at least one target musculoskeletal joint to provide a reaction force during the performance of the exercise. The collaborative robot includes one or more force sensors for measuring the reaction force applied by the user during the execution of the motion.

45. The method according to claim 44, The collaborative robot is a six-degree-of-freedom collaborative robot configured to move the musculoskeletal joint of at least one target over its entire range of motion, or The collaborative robot is configured to simultaneously move a combination of multiple joints, including the musculoskeletal joint of at least one target, in the multi-plane joint motion. A method wherein the reaction force applied by the user during the execution of the multi-plane joint motion is measured by the collaborative robot.

46. The method according to claim 44 or 45, The force data and joint angle data of the user measured during the performance of the aforementioned exercise are stored. The collaborative robot is configured to be able to reproduce previously performed movements using the stored force data and joint angle data. A method for evaluating changes in the control of at least one target musculoskeletal joint by comparing the user's force data and joint angle data, measured during the execution of a movement reproduced by the collaborative robot, with the stored force data and joint angle data.

47. The method according to any one of claims 44 to 46, The collaborative robot stores or determines the threshold values ​​of the motion and force envelope for the said motion. A method for generating a warning if the force and / or position of the user measured during the performance of the exercise is outside the range of thresholds for the motion and force envelope for the exercise.

48. A method according to any one of claims 44 to 47, A method wherein the collaborative robot is configured to maintain the force sensor perpendicular to the point of contact with the user while performing the one or more motions.

49. The method according to any one of claims 1 to 48, The aforementioned one or more movements include a set of simultaneous movements performed by multiple musculoskeletal joints, A method in which each simultaneous operation has a separate target parameter as a function of time.

50. A method according to any one of claims 1 to 49, The step of providing the target parameters comprises creating one or more plots representing the range of motion of the musculoskeletal joint of the at least one target in three dimensions, and the associated control levels.

51. The method according to claim 50, The above-mentioned movement 1 or more includes multiple combinations of multi-plane joint movements, A method comprising the step of creating one or more plots representing the range of motion of the at least one target musculoskeletal joint in three dimensions and the associated control levels, wherein the range is associated with performing a functional task using the at least one target musculoskeletal joint.

52. A method according to any one of claims 1 to 51, This method is The step of repeating the method for the musculoskeletal joint opposite to the musculoskeletal joint of the at least one target musculoskeletal joint, A method further comprising the step of creating a comparison of control levels with respect to the musculoskeletal joint opposite to the at least one target musculoskeletal joint.

53. A method according to any one of claims 1 to 52, The method wherein the aforementioned multiple motions include one or more equilibrium motions.

54. The method according to claim 53, The one or more balance movements described above include the user remaining still in a first posture. The method includes a method in which the one or more target parameters include a deviation from the initial position.

55. The method according to claim 54, The first posture is a method that includes a one-legged standing posture, a two-legged standing posture, a seated posture, or a kneeling posture.

56. The method according to claim 54 or 55, The first posture is performed on a surface that the user can displace in the pitch direction, roll direction, and / or yaw direction.

57. The method according to any one of claims 54 to 56, The first posture is a method performed while the user is viewing a moving field of view.

58. A method according to any one of claims 54 to 57, A method in which the user is instructed to maintain a stillness in the first posture with his eyes open for a first period of time, and then to maintain a stillness in the first posture with his eyes closed for a second period of time.

59. The method according to claim 53, The aforementioned one or more equilibrium motions include one or more oscillating motions. The user is instructed to follow a shaking pattern that shakes at a predetermined speed along a predetermined path. The method wherein the target parameter is the deviation from the oscillation pattern.

60. A method according to any one of claims 1 to 59, The neuromodulatory therapy is provided as a treatment for one or more conditions, including arthrogenic muscle shielding (AMI), stroke, neuropathy, mild cognitive impairment, balance disorders, chronic pain, dissociative disorders, and neuroimmunological disorders, or as a rehabilitation program following treatment of at least one target musculoskeletal joint.

61. A computer program product, A computer program product comprising instructions for causing a processor to perform the method according to any one of claims 1 to 60.

62. A neuromodulatory therapy (NMT) system, A neuromodulatory therapy device that includes at least a resistance element, A sensing device including at least one sensor configured to measure one or more target parameters when a user is performing exercise using the neuromodulation therapy device, One or more output devices configured to output the presentation of one or more of the one or more target parameters, A computer device comprising at least one processor, memory, and a communication interface, The communication interface is configured to receive measured values ​​of one or more target parameters from the sensing device. The at least one processor is configured to control the one or more output devices, A system wherein the memory stores instructions for the at least one processor to perform the method according to any one of claims 1 to 60.

63. The system according to claim 62, The computer device is a mobile computer device that includes a display device configured to display the presentation of one or more target parameters as a function of time. The mobile computer device is configured to receive the measured values ​​from the sensing device in real time and to display feedback using the display device.

64. The system according to claim 62 or 63, The aforementioned nerve conditioning therapy device is an extension device, The aforementioned target parameter is force, The force is measured by one or more load cells connected to the resistive element. The extension device is made of substantially rigid or stiff components in order to maximize the force transmitted to the one or more load cells during the performance of the motion.

65. A system according to any one of claims 62 to 64, The at least one sensor is at least one portable load cell, The aforementioned communication interface is a wireless communication module, The system further comprises a mounting mechanism configured to allow the sensing device to be detachably attached to the neuromodulatory therapy device. The neuromodulatory therapy device is a system having one or more movable surfaces, wherein the movement of the one or more movable surfaces during the performance of the exercise is configured to apply a load to at least one of the at least one portable load cell.

66. A system according to any one of claims 62 to 65, The sensing device includes a force sensor, an inertial measuring unit (IMU), and a communication module. The system is configured such that the communication module wirelessly transmits force data and posture data measured by the force sensor and the inertial measuring unit (IMU) to the computer device in order to estimate the force applied by the user and the user's joint angles as a function of time during the performance of the movement.

67. A system according to any one of claims 62 to 66, The aforementioned target parameter is force, The force is measured by one or more load cells connected to the resistive element in the system.

68. A system according to any one of claims 62 to 67, The resistance element is rigidly connected to the sensing device at its first end and rigidly connected to the body attachment device at its second end. The sensing device is further connected to a fixed point, The body attachment device is a system configured to be attached to the user's body.

69. The system according to claim 68, The nerve conditioning therapy device includes at least a first resistance element and a second resistance element. The sensing device includes at least a first sensor and a second sensor, The first resistive element is rigidly connected to the first sensor at its first end and rigidly connected to the body mounting device at its second end. The first sensor is further connected to the first fixed point, The second resistive element is rigidly connected to the second sensor at its first end and rigidly connected to the body mounting device at its second end. The second sensor is further connected to a second fixed point. The body attachment device is configured to be attached to the user's body part, A system in which the first sensor and the second sensor are connected orthogonally to the body-mounted device, or are arranged to measure orthogonal components of the one or more target parameters, respectively.

70. A system according to any one of claims 62 to 69, The sensing device is One or more joint angle measuring devices configured to measure the user's joint angles as a function of time, A system including a communication interface configured to transmit the user's joint angle measurements in real time.

71. The system according to claim 70, The system includes one or more joint angle measuring devices configured to measure the joint angles of the user when the user is wearing the device.

72. The system according to claim 62 or 63, The neuromodulatory therapy device includes a collaborative robot (cobot) having an end effector. The aforementioned collaborative robot is programmed to follow a predetermined path while performing the aforementioned motion. The user is instructed to move one or more muscles associated with at least one target musculoskeletal joint to provide a reaction force during the performance of the exercise. The end effector is a system that includes one or more force sensors for measuring the reaction force applied by the user during the performance of the motion.

73. The system according to claim 72, The collaborative robot is a six-degree-of-freedom collaborative robot configured to move the musculoskeletal joint of at least one target over its entire range of motion, or The collaborative robot is configured to simultaneously move multiple combinations of joints, including the musculoskeletal joint of at least one target, in the multi-faceted joint movement described above. The system measures the reaction force applied by the user during the performance of the aforementioned multi-faceted joint movement by the collaborative robot.

74. The system according to claim 72 or 73, It is configured to store the user's force data and joint angle data measured during the performance of the aforementioned exercise. The collaborative robot is configured to be able to reproduce previously performed movements using the stored force data and joint angle data. A system configured to evaluate changes in the control of at least one target musculoskeletal joint by comparing the user's force data and joint angle data, measured during the execution of a movement reproduced by the collaborative robot, with the stored force data and joint angle data.

75. A system according to any one of claims 72 to 74, The collaborative robot stores or determines the threshold values ​​of the motion and force envelope for the said motion. A system configured to generate a warning if the user's force and / or posture, measured during the performance of the exercise, falls outside the threshold range of the motion and force envelope for the exercise.

76. A system according to any one of claims 72 to 75, The collaborative robot is configured to maintain the force sensor perpendicular to the point of contact with the user during the execution of the motion.

77. A system according to any one of claims 62 to 76, The sensing device is a system that includes a computer vision system configured to capture and measure the joint angles of the user during the performance of the movement.

78. A system according to any one of claims 62 to 77, The computer device is further configured to upload data to an external data storage location, forming a system.

79. A neuromodulatory therapy (NMT) device, At least one resistive element, The device comprises a sensing device including at least one sensor configured to measure one or more target parameters when a user is performing exercise using the device, The sensing device is configured to provide the measured values ​​of one or more target parameters to a computer device including at least one processor, memory, and a communication interface. The computer device is operably connected to or integrated with one or more output devices configured to output the presentation of one or more target parameters. The device wherein the memory stores instructions that constitute the processor to perform the method according to any one of claims 1 to 60.

80. The apparatus according to claim 79, The device in question is an extension device, The aforementioned target parameter is force, The force is measured by a load cell connected to the resistive element. The extension device is made of substantially rigid or stiff components in order to maximize the force transmitted to the load cell during the performance of the motion.

81. The apparatus according to claim 79 or 80, The at least one sensor is a portable load cell, The aforementioned communication interface is a wireless communication module, The device further includes a mounting mechanism configured to allow the sensing device to be detachably attached to the device, The device has one or more movable surfaces, and the movement of the one or more movable surfaces during the motion is configured to apply a load to the portable load cell.

82. The apparatus according to any one of claims 79 to 81, The sensing device includes a force sensor, an inertial measuring unit (IMU), and a communication module. The communication module is configured to wirelessly transmit force data and posture data measured by the force sensor and the inertial measuring unit (IMU) to the computer device in order to estimate the force applied by the user and the user's joint angles as a function of time during the performance of the movement.

83. The apparatus according to any one of claims 79 to 82, The aforementioned target parameter is force, The force is measured by a load cell connected to the resistive element in the apparatus.

84. The apparatus according to any one of claims 79 to 83, The at least one resistance element is rigidly connected to the sensing device at its first end and rigidly connected to the body attachment device at its second end. The sensing device is further connected to a fixed point, The body attachment device is a device configured to be attached to the user's body.

85. The apparatus according to claim 84, The device comprises at least a first resistive element and a second resistive element. The sensing device includes at least a first sensor and a second sensor, The first resistive element is rigidly connected to the first sensor at its first end and rigidly connected to the body mounting device at its second end. The first sensor is further connected to the first fixed point, The second resistive element is rigidly connected to the second sensor at its first end and rigidly connected to the body mounting device at its second end. The second sensor is further connected to a second fixed point. The body attachment device is configured to be attached to the user's body, The first sensor and the second sensor are connected orthogonally to the body-mounted device, or are arranged to measure the orthogonal components of the one or more target parameters, respectively.

86. The apparatus according to any one of claims 79 to 85, The sensing device is A joint angle measuring device configured to measure the user's joint angle as a function of time, A device including a communication interface configured to transmit the user's joint angle measurements in real time.

87. It's a kit, A neuromodulatory therapy device according to any one of claims 79 to 86, A kit comprising: a computer program product including instructions for causing the processor to perform the method according to any one of claims 1 to 60.

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