Sensory modulation system for improving gait function and / or balance control

Abstract

Various systems for improvising a patient's sensorimotor function may include at least one force and / or pressure sensor associated with the patient's at least one lower limb or prosthetic limb, at least one movement and / or angle sensor associated with the patient's at least one lower limb or prosthetic limb, a processing unit configured to receive the force and / or pressure signals and the movement and / or angle signals, generate an estimated center of pressure and center of gravity, and generate a balance stimulation signal based on the estimated center of pressure and center of gravity, and at least one sensory stimulation unit disposed on the patient's at least one lower limb or prosthetic limb, the sensory stimulation unit comprising at least two stimulation devices operable to provide stimulation to the patient based on the balance stimulation signal.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. §119(e) to U.S. Provisional Application No. 63 / 405,115, filed September 9, 2022, entitled "Sensory Modulation System for Improving Balance Control," which is hereby incorporated by reference in its entirety.

[0002] Various embodiments herein relate generally to systems for improving at least one of balance control and walking function, and more particularly to devices that measure pressure and / or force-related information and generate sensory stimuli or notifications that encode that information. [Background technology]

[0003] Loss of balance and associated falls are significant problems for individuals with lower limb injuries and those with lower limb (LL) amputations. This typically leads to decreased activity levels, reduced participation in social activities, and increased fear of falling. In fact, 52.4% of lower limb amputees report having fallen in the previous year, and 66% of above-knee amputees report having fallen annually, double the rate for healthy individuals over the age of 65. Falls can have a significant impact on subsequent morbidity, disability, and risk of mortality. Falls in amputees can also have serious consequences for the residual limb and can damage prosthetic devices, leading to a lack of confidence in certain prosthetic devices and often to their cessation of use.

[0004] Soldiers who sustain lower extremity injuries and / or losses are often young and capable of high performance at the time of injury. These individuals may be at increased risk for fall-causing injuries following rehabilitation due to their continued active lifestyles, which sometimes include remaining on active duty and deployment. Even after participating in advanced rehabilitation and receiving state-of-the-art prosthetics and orthotics, soldiers with lower extremity injuries and / or losses remain at risk for falls.

[0005] Younger and older individuals with amputees have a similar overall risk of falls. Older individuals, including those in the Veterans Health Administration (VHA) system, have significant limitations in their ability to recover, while younger service members are at risk due to more challenging activities. Balance impairments and associated falls are a major concern for older individuals and those with amputees. Increasing age increases the consequences of falls and also decreases the ability to effectively respond to loss of balance, heightening the importance of prevention and avoiding problematic loading conditions / positions. Vision, strength, and cognitive impairments can develop with age and worsening medical conditions, all contributing to the increased risk of falls for older individuals with amputees.

[0006] General rehabilitation practices typically begin in a highly controlled environment and include basic gait and balance training activities on parallel bars to help the patient become accustomed to new sensory and motor skills and situations related to the limb / loss or trauma. This includes "trusting" the new limb and relearning to stand and walk. Activities gradually progress and become more difficult and may include activities specific to the soldier's requirements.

[0007] While previous studies of targeted fall mitigation training have demonstrated success, these interventions are often conducted on complex and cost-prohibitive systems, such as virtual environments with perturbation platforms and treadmills, which require significant space and operator training. These systems are typically impractical for use in typical clinical therapy settings. Furthermore, conducting rehabilitation on a treadmill rather than in an environment with more natural sensory input, including visual flow, is less ecologically effective. Furthermore, such systems lack important sensory stimuli, such as high-fidelity exteroceptive and proprioceptive information about limb load and position, which are highly relevant to gait and balance function.

[0008] There is a need in the art for improved sensory stimulation systems for improved fall mitigation and / or intervention for patients with lower limb injury or loss, as well as patients with neurodegenerative diseases that cause balance problems. Summary of the Invention

[0009] Discussed herein are various systems, devices, and methods for improving a patient's sensorimotor function.

[0010] In Example 1, a system for improving a patient's sensorimotor function includes at least one force and / or pressure sensor associated with at least one lower limb or prosthetic limb of the patient, the at least one force and / or pressure sensor configured to detect force and / or pressure information related to the lower limb or prosthetic limb and transmit a force and / or pressure signal based on the force and / or pressure information; and at least one motion and / or angle sensor associated with the at least one lower limb or prosthetic limb of the patient, the at least one motion and / or angle sensor configured to detect motion and / or angle information related to the lower limb or prosthetic limb and transmit a motion and / or angle signal based on the motion and / or angle information. a processing unit configured to receive the force and / or pressure signals and the motion and / or angle signals, generate a patient-specific virtual biomechanical model based on the force and / or pressure signals and the motion and / or angle signals to generate an estimated center of pressure and center of gravity, and generate a balance stimulation signal based on the estimated center of pressure and center of gravity; and at least one sensory stimulation unit disposed on at least one lower limb of the patient or on a prosthetic limb, the at least one sensory stimulation unit comprising at least two stimulators operable to provide stimulation to the patient based on the balance stimulation signal.

[0011] Example 2 relates to the system of example 1, wherein a first of the at least one force and / or pressure sensor is associated with a first pad, the first pad being disposable under the patient's first foot or prosthetic foot.

[0012] Example 3 relates to the system of example 2, wherein a second of the at least one force and / or pressure sensor is associated with a second pad, the second pad being disposable under the patient's second leg or prosthetic leg.

[0013] Example 4 relates to the system of example 1, wherein the at least one motion and / or angle sensor includes five motion and / or angle sensors.

[0014] Example 5 relates to the system of example 4, wherein each of the five motion and / or angle sensors is an inertial motion unit disposed in the sensor processing module.

[0015] Example 6 relates to the system described in Example 1, wherein the at least one sensory stimulation unit includes a first stimulation unit positioned on a first lower limb or prosthetic limb of the patient and a second stimulation unit positioned on a second lower limb or prosthetic limb of the patient.

[0016] Example 7 relates to the system of example 1, wherein the at least one sensory stimulation unit comprises four stimulators.

[0017] Example 8 relates to the system of example 1, further comprising a user interface operably coupled to the processing unit, the user interface configured to display the patient-specific virtual biomechanical model.

[0018] Example 9 relates to the system of example 8, wherein the user interface comprises an application within a mobile device.

[0019] Example 10 relates to the system of Example 9, wherein the mobile device includes a laptop or a smartphone.

[0020] In Example 11, a system for improving a patient's sensorimotor function includes at least one force and / or pressure sensor associated with at least one lower limb or prosthetic limb of the patient, the at least one force and / or pressure sensor configured to detect force and / or pressure information related to the lower limb or prosthetic limb and transmit a force and / or pressure signal based on the force and / or pressure information; and at least one motion and / or angle sensor associated with at least one lower limb or prosthetic limb of the patient, the at least one motion and / or angle sensor configured to detect movement and / or angle information related to the lower limb or prosthetic limb and transmit a movement and / or angle signal based on the movement and / or angle information; and at least one motion and / or angle sensor configured to receive the force and / or pressure signal and the movement and / or angle signal and transmit a force and / or pressure signal. and / or a processing device configured to generate a patient-specific virtual biomechanical model based on the pressure signals and the movement and / or angle signals, generate an estimated center of pressure and center of gravity, and generate a balance stimulation signal based on the estimated center of pressure and center of gravity; at least one sensory stimulation unit disposed on at least one lower limb of the patient or prosthetic limb, the at least one sensory stimulation unit comprising at least two stimulation devices operable to provide stimulation to the patient based on the balance stimulation signal; and a user interface operably coupled to the processing device, the user interface configured to receive information from the processing device regarding the patient-specific virtual biomechanical model and to display the patient-specific virtual biomechanical model based on the information from the processing device.

[0021] Example 12 relates to the system of Example 11, wherein a first of the at least one force and / or pressure sensor is associated with a first pad, the first pad being disposable under the patient's first foot or prosthetic leg, and a second of the at least one force and / or pressure sensor is associated with a second pad, the second pad being disposable under the patient's second foot or prosthetic leg.

[0022] Example 13 relates to the system of Example 11, wherein the at least one motion and / or angle sensor comprises five motion and / or angle sensors, the first and second motion and / or angle sensors being positioned on a first lower limb or prosthetic limb of the patient, the third and fourth motion and / or angle sensors being positioned on a second lower limb or prosthetic limb of the patient, and the fifth motion and / or angle sensor being positioned on the patient's lower back.

[0023] Example 14 relates to the system described in Example 13, wherein each of the five motion and / or angle sensors is an inertial motion unit disposed within a sensor processing module, and the fifth motion and / or angle sensor is operably coupled to a local central processing unit, and the local central processing unit communicates with the processing unit.

[0024] Example 15 relates to the system described in Example 11, wherein the at least one sensory stimulation unit comprises a first stimulation unit positioned on a first lower limb or prosthetic limb of the patient and a second stimulation unit positioned on a second lower limb or prosthetic limb of the patient, each of the first and second stimulation units comprising a band configured to be connectable to the lower limb or prosthetic limb, at least two stimulation devices including four stimulation devices attached to the band, and at least one movement and / or angle sensor associated with one of the four stimulation devices.

[0025] Example 16 relates to the system of Example 11, wherein the user interface comprises an application in a mobile device, and the mobile device comprises a laptop or a smartphone.

[0026] In Example 17, a system for improving a patient's sensorimotor function includes a first foot pad unit including a first foot pad having at least one first force and / or pressure sensor positionable under a first foot or prosthetic leg of a first lower limb or prosthetic limb of the patient, and a second foot pad unit including a second foot pad having at least one second force and / or pressure sensor positionable under a second foot or prosthetic leg of a second lower limb or prosthetic limb of the patient, wherein each of the at least one first and second force and / or pressure sensor is configured to detect force and / or pressure information regarding the first and second lower limbs or prosthetic limbs, respectively, and to transmit a force and / or pressure signal based on the force and / or pressure information. The system further includes first and second sensor processing modules comprising at least one first motion and / or angle sensor associated with the patient's first lower limb or prosthetic limb, third and fourth sensor processing modules comprising at least one second motion and / or angle sensor associated with the patient's second lower limb or prosthetic limb, and a fifth sensor processing module comprising at least one third motion and / or angle sensor associated with the patient's lumbar spine, wherein each of the at least one first, second, and third motion and / or angle sensor is configured to detect motion and / or angle information and transmit a motion and / or angle signal based on the motion and / or angle information. The system also includes a processing device configured to receive the force and / or pressure signals and the motion and / or angle signals, generate a patient-specific virtual biomechanical model based on the force and / or pressure signals and the motion and / or angle signals, generate an estimated center of pressure and center of gravity, and generate a balance stimulus signal based on the estimated center of pressure and center of gravity. Additionally, the system includes at least one sensory stimulation unit disposed on at least one lower limb or prosthetic limb of the patient, the at least one sensory stimulation unit including at least two stimulators operable to provide stimulation to the patient based on the balance stimulation signal.The system also includes a user interface operably coupled to the processing device, the user interface configured to receive information from the processing device regarding the patient-specific virtual biomechanical model and to display the patient-specific virtual biomechanical model based on the information from the processing device.

[0027] Example 18 relates to the system of example 17, wherein the fifth sensor processing module comprises a local central processing unit, and the local central processing unit is in communication with the processing unit.

[0028] Example 19 relates to the system of example 17, wherein the at least one sensory stimulation unit comprises a first and a second stimulation unit. The first stimulation unit comprises a first band configured to be placed on a first lower limb or prosthetic limb of the patient and be connectable to the first lower limb or prosthetic limb, four first stimulation devices attached to the first band, and one of the first and second sensor processing modules associated with one of the four stimulation devices. The second stimulation unit comprises a second band configured to be placed on a second lower limb or prosthetic limb of the patient and be connectable to the second lower limb or prosthetic limb, four second stimulation devices attached to the second band, and one of the third and fourth sensor processing modules associated with one of the four stimulation devices.

[0029] Example 20 relates to the system of Example 17, wherein the user interface comprises an application in a mobile device, and the mobile device comprises a laptop or a smartphone.

[0030] While multiple embodiments are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments. As will be realized, various implementations can be modified in various obvious aspects without departing from the spirit and scope thereof. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief explanation of the drawings]

[0031] [Figure 1] FIG. 1 is a schematic diagram of a system for improving a patient's sensorimotor function, according to one embodiment. [Figure 2A] FIG. 1 is a perspective view of a foot pad unit according to one embodiment. [Figure 2B] FIG. 1 is a perspective view of a tactile stimulation unit, according to one embodiment. [Figure 3A] 1 is a schematic illustration of a patient standing and wearing a set of sensory processing modules, according to one embodiment. [Figure 3B] 3B is a representation of an electronically generated human model that replicates the limb movements and positions of the patient in FIG. 3A, according to one embodiment. [Figure 4A] FIG. 3B is a schematic illustration of the patient of FIG. 3A with the right leg forward while the patient is walking, according to one embodiment. [Figure 4B] 4B is a representation of an electronically generated human model that replicates the movements and positions of the patient's limbs in FIG. 4A, according to one embodiment. [Figure 5A] FIG. 3B is a schematic illustration of the patient of FIG. 3A with the right leg raised while the patient is walking, according to one embodiment. [Figure 5B] 5B is a representation of an electronically generated human model that replicates the limb movements and positions of the patient in FIG. 5A, according to one embodiment. [Figure 6A] FIG. 1B is a rear view of a patient wearing force / pressure sensors and motion / angle sensors with their right leg forward while walking, with a schematic depiction of the patient's center of pressure and center of mass calculations, according to one embodiment. [Figure 6B] 6B is a rear view of the patient of FIG. 6A when the patient places their right foot on the ground while walking, along with a schematic depiction of the calculation of the patient's center of pressure and center of mass, according to one embodiment. [Figure 6C] FIG. 6B is a rear view of the patient of FIG. 6A as the system provides stimulation to the patient based on calculations of the center of pressure and center of mass, according to one embodiment. [Figure 7]1 is a flowchart depicting steps of a method for tracking patient movements / activities and providing stimulation to a patient based on those movements / activities, according to one embodiment. [Figure 8A] 1 is a representative depiction of a mobile device interface, according to one embodiment. [Figure 8B] 1 is a representative depiction of a mobile device interface, according to one embodiment. [Figure 9] FIG. 1 is a schematic diagram of a computing device for use or combination with any of the systems disclosed or contemplated herein, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0032] Various embodiments herein relate to systems and devices for providing relevant sensory stimuli to patients. More specifically, various systems and devices herein have both force / pressure sensors and movement / angle sensors that provide information to a processing unit, which then uses the information to provide real-time sensory stimuli to the patient related to the patient's balance and / or loss of balance. Additional system and device embodiments may include a patient-specific virtual model created by a system processing unit and / or system software to assimilate various force / pressure / movement / angle and other balance parameters for the purpose of generating refined and accurate sensory stimuli to the patient. Certain implementations may be used for fall mitigation training by patients with lower limb injury or loss, including as part of rehabilitation care. That is, while some of the various system and device embodiments disclosed or contemplated herein can promote and / or enhance sensory motor function in patients with lower limb injury or loss, other embodiments may be used to promote / enhance sensory motor function in patients with other conditions, including neurological conditions such as stroke. Furthermore, in certain exemplary implementations, the various systems and devices herein can facilitate and / or enhance a patient's sensory-motor function in any environment and using any of the conditions disclosed or contemplated herein.

[0033] According to one embodiment, an exemplary system 10 is depicted schematically in Figure 1. The system 10 includes two foot pad units 12A, 12B, with the right foot pad unit 12A including a foot pad positionable under a patient's right foot (or artificial limb) 30A and the left foot pad unit 12B including a foot pad positionable under a patient's left foot (or artificial limb) 30B, each of the foot pads of the foot pad units 12A, 12B including at least one force or pressure sensor. Furthermore, system 10 also includes five motion and angle sensors 14A, 14B, 14C, 14D, and 14E, with right foot sensor 14A attached to or positioned near the patient's right foot (or artificial limb) 30A, left foot sensor 14B attached to or positioned near the left foot (or artificial limb) 30B, right leg sensor 14C attached to or positioned near the right thigh (or artificial limb) 32A, left leg sensor 14D attached to or positioned near the left thigh (or artificial limb) 32B, and lumbar sensor 14E attached to or positioned near the lumbar region 34. Additionally, system 10 includes two tactile stimulation units 16A, 16B, with right leg stimulation unit 16A attached to the right thigh 32A and left leg stimulation unit 16B attached to the left thigh 32B. According to certain implementations, as discussed in additional detail below, the right leg sensor 14C and the left leg sensor 14D can be incorporated into the sensory stimulation units 16A and 16B, and the right foot sensor 14A and the left foot sensor 14B can be incorporated into the right foot pad unit 12A and the left foot pad unit 12B. Applicants note that due to the use of various device / system embodiments herein by patients with injured limbs, the use of the term foot or limb herein can also refer to any type of prosthetic or artificial limb. Furthermore, the terms "artificial limb" and "prosthetic limb" as used herein are intended to have the same meaning and be interchangeable.

[0034] System 10 also includes a central processing unit 18 wirelessly coupled to footpad units 12A-12B, motion / angle sensors 14A-14E, and force / pressure sensors of tactile stimulation units 16A, 16B, such that information from the force / pressure sensors and motion / angle sensors 14A-14E of units 12A-12B can be transmitted or otherwise communicated to central processing unit 18, which can process the information and transmit sensory stimulation instructions to sensory stimulation units 16A, 16B to provide sensory stimulation to the patient, as described in further detail below. That is, central processing unit 18 uses information from the sensors of units 12A, 12B and sensors 14A-14E to make calculations regarding when to activate stimulation units 16A, 16B to provide sensory stimulation to the patient during use, as discussed in further detail below. In one implementation, stimulation units 16A, 16B provide sensory tactile stimulation in the form of vibrations. Alternatively, the stimulation units 16A, 16B may provide any form of sensory stimulation.

[0035] In alternative embodiments, the system may have one sensory stimulation unit (including, for example, situations where one of two limbs has been amputated or severely injured). In further alternatives, three or more stimulation units may be used. According to other alternative implementations, the number of motion / angle sensors may be 1, 2, 3, 4, 6, 7, 8, 9, 10, or any other number of sensors that may be strategically positioned on the patient to gather information. According to additional alternatives, each of the sensors 14A-14E may have a local processing unit associated with the sensor 14A-14E such that each may perform local processing of the information collected by the respective sensor 14A-14E.

[0036] In one particular alternative embodiment as shown in FIG. 1, the lumbar sensor 14E has a local central processing unit 20 coupled thereto, which performs the central processing operations described above, communicates with the central processing unit 18, and wirelessly communicates with the force / pressure sensors and other motion / angle sensors 14A-14D in the foot pad units 12A, 12B to transmit data and other information, as described in additional detail below.

[0037] Additionally, system 10 may also have at least one computer or mobile device 22 coupled to processing unit 18 and / or processing unit 20 via a network 24, such as a local area network or the Internet 24. Further, one or more servers 26 may also be coupled to system 10, either directly to computer / mobile device 22 or via network 24, such that server 26 can perform any of the processes disclosed or contemplated herein. As discussed elsewhere herein, computer or mobile device 22 may be used by a clinician to set parameters for use of system 10 (or any system embodiment herein) and / or to receive results regarding the patient's use of the system, as described in additional detail herein. Alternatively, computer or mobile device 22 may be used by a patient during use of system 10 to input information into system 10 and / or to access information about the patient's use of system 10 or analyses of such use generated by system 10, as described in further detail below. For example, in one embodiment, as described in additional detail below, an application may be loaded onto a patient's phone such that the phone acts as a mobile device 22 that can be used to interface with system 10 in the manner described above and elsewhere herein.

[0038] One exemplary embodiment of the foot pad units 12A / 12B is depicted in FIG. 2A. As described above, each foot pad unit 12A, 12B has a foot pad 40A for placement under a patient's foot, with at least one force / pressure sensor (not shown) disposed within / integrally with the foot pad 40A to sense force and / or pressure generated by the force of the patient's foot contacting the foot pad 40A. More specifically, in one specific embodiment, each foot pad 40A of each foot pad unit 12A, 12B has four force / pressure sensors (not shown): a front sensor, a rear sensor, a lateral sensor, and a medial sensor. Alternatively, each foot pad 40A can have 2, 3, 5, 6, 7, 8, 9, 10, 11, 12, or any number of sensors, as needed, to track the center of pressure ("COP") associated with each patient's foot. For example, in certain embodiments, foot pad 40A and / or the entire foot pad unit 12A, 12B can be a commercially available foot pad or unit available as part of the Walkasins® system. According to another implementation, foot pad 40A and / or units 12A, 12B can be any of the embodiments of a foot pad or foot pad unit disclosed in U.S. Patent No. 8,974,402, entitled "Sensor Prosthetic for Improved Balance Control," issued March 10, 2015, and incorporated herein by reference in its entirety. Each unit 12A / 12B also includes a leg band 40B that can be positioned around and attached to the patient's lower leg, and a connector band 40C that couples band 40B to foot pad 40A. In the particular implementation shown, each foot pad unit 12A / 12B has a local processing unit 42 coupled to the connector band 40C (or leg band 40B) so that the local processing unit 42 can receive signals from the pressure / force sensors in the foot pad 40A, process the signals, and transmit information about those signals and processing to a central processing unit (such as the central processing unit 18 and / or local central processing unit 20 as described above).Additionally, each unit 12A / 12B may also have one of the motion and angle sensors 44 coupled to the leg band 40B (or connector band 40C). For example, the motion and angle sensor 44 in the right unit 12A may be the sensor 14A described above, and the motion and angle sensor 44 in the left unit 12B may be the sensor 14B described above.

[0039] In certain embodiments, each foot pad (such as foot pad 40A in foot pad units 12A, 12B) can provide foot pressure data used to calculate the center of pressure ("COP"). That is, an exemplary foot pad includes pressure sensors positioned at locations corresponding to the anatomical pressure distribution on the plantar surface of the foot. The posterior sensor covers the majority of pressure from the heel of the foot. The lateral sensor covers the lateral side of the foot up to the fifth metatarsal head. The anterior sensor is located on the ball of the foot between the first and fifth metatarsal heads. The medial sensor is located on the medial side of the foot up to the first metatarsal head so that the sensor is loaded by both the first metatarsal head and the lower surface of the arch. Regardless of the number of pressure sensors and their positioning, foot pressure amplitude and distribution data from these sensors can be used to estimate a patient's COP during activities such as standing and walking.

[0040] An exemplary implementation of the tactile stimulation units 16A / 16B is depicted in FIG. 2B. The stimulation units 16A / 16B in this embodiment have a band 50 with four vibrotactile actuators 52A, 52B, 52C, 52D strategically positioned around the band 50 to be positioned at anterior, posterior, medial, and lateral positions relative to the patient's leg. In certain embodiments, the tactile stimulation units 16A / 16B can be commercially available stimulation units available as part of the Walkasins® system, or alternatively, can be any of the stimulation units disclosed in U.S. Pat. No. 8,974,402, incorporated by reference above. Furthermore, one of the actuators 52A as shown can also be a motion and angle sensor 52A coupled to the band 50. For example, the actuator 52A of the right tactile stimulation unit 16A can also be the motion and angle sensor 14C described above, while the actuator 52A of the left tactile stimulation unit 16B can also be the motion and angle sensor 14D described above.

[0041] According to some implementations, each motion / angle sensor is an inertial motion unit (“IMU”). Exemplary commercially available IMUs include the ST Micro ISM330 and the Invensense / TDK ICM-20948. Furthermore, in certain embodiments as described above, each of the motion / angle sensors (such as sensors 14A-14E) in system 10 is incorporated into a unit that includes a local processing device. Such a unit may be referred to herein as a sensor processing module (“SPM”), such that the motion and angle sensors 14A-14E are also SPMs 14A-14E. The SPM can capture IMU data and provide local sensor fusion functionality and connectivity. One exemplary SPM embodiment has an IMU (9 axes, such as a Bosch BNO055), a microprocessor (such as an ARM Cortex-M4 with floating-point hardware or the like), a wireless transceiver (such as Bluetooth Low Energy 5.0+), a battery (such as a lithium polymer or other high current output / low capacity battery required for motor activation), an analog input port (with amplification and filtering circuitry for reading resistance from the foot sensors), a vibrotactile actuator (such as a linear resonant actuator), and drive circuitry for coupling to additional vibrotactile actuators in the tactile stimulation unit, or any combination of these components / features. Additionally, certain SPM embodiments are capable of over-the-air (OTA) updates and configuration to firmware, fusing sensor information and transferring associated data to other system modules, processing model data and providing activation signals to other SPMs, providing power to itself and connected peripherals, providing amplitude and frequency modulated signals to drive actuators in the tactile stimulation unit, and reading analog signals on at least four input channels, or any combination of these capabilities.

[0042] In certain embodiments, a central processing unit (e.g., central processing unit 18) can calculate patient-specific biomechanical model data (including an estimate of the patient's center of mass (“COM”)), control system configuration, provide secure storage, analyze data, or any combination thereof. Data collected to build the patient-specific model (as discussed in more detail below) can be recorded and analyzed locally by the central processing unit. Furthermore, in various aspects, the central processing unit can additionally perform as a gateway connecting system 10 to remote hardware (e.g., server 26 and / or computer / mobile device 22, as described above) for downloading data for analysis or storage. In some implementations, an application running on an off-the-shelf mobile device (e.g., device 22), such as a phone, tablet, or laptop, can provide the central processing unit functionality. That is, central processing unit 18 can be wirelessly connected to a mobile device (e.g., device 22) such that the mobile device and the central processing unit can communicate. In certain embodiments, central processing unit 18 can provide both the functionality of a gateway and a control interface for the clinician / technician or patient during a sensory stimulation exercise. In an exemplary implementation, the central processing unit 18 can communicate with the SPMs 14A-14E to retrieve and transfer data for secure storage, display relevant usage data or live streaming data from the system, calculate patient-specific models (in real time or offline), send stimulation activation parameters to the system 10, manage, configure, and calibrate the SPMs 14A-14E, or any combination of these operations. In a specific example, the central processing unit 18 can be a laptop or a mobile phone such as a Samsung Galaxy S9.

[0043] In various embodiments, communication between central processing unit 18 and SPMs 14A-14E, between SPMs 14A-14E, and / or between servers, computers / mobile devices 22, processing units 18, and / or processing units 20 can be via physical connections (wired) or via wireless communication. For example, the wireless communication can be BLE 5.0 (Bluetooth Low Energy). Alternatively, other known wireless technologies such as ANT, Thread, Zigbee, Wi-Fi, or proprietary protocols in the ISM band can be used.

[0044] As mentioned above, in certain implementations, system 10 can use an electronic full-body human model, the exemplary versions of which are depicted in FIGS. 3B, 4B, and 5B (and discussed in more detail below). In certain embodiments, system embodiments herein can utilize sensor information to generate the model in real time. The model is generated by information from motion / angle sensors (such as sensors 14A-14E discussed above with respect to system 10) attached to the patient. Parameters that can be tracked by the motion / angle sensors can include, but are not limited to, heel strike ("HS") and toe off ("TO") accuracy, step length, step width, toe clearance during swing, thigh position, anterior / posterior ("A / P") and medial / lateral ("M / L") angular momentum, etc. In one embodiment, the model is written in Java, but can be created in any software.

[0045] One example of an IMU used to generate an electronic, real-time, full-body human model is shown in FIGS. 3A-5B. More specifically, as shown in FIG. 3A, IMUs 60A, 60B, 60C, 60D, and 60E are positioned on a patient to track the patient's movements. More specifically, IMU 60A is attached to the patient's right foot or ankle, IMU 60B is attached to the patient's left foot or ankle, IMU 60C ​​is attached to the patient's right thigh, IMU 60D is attached to the patient's left thigh, and IMU 60E is attached to the patient's lower back in a manner similar to that described above with respect to FIG. 1. Thus, the resulting model generated by IMUs 60A-60E (as positioned in FIG. 3A) is shown in FIG. 3B, which depicts a graphic user interface displaying the human model, including a front view 62 and a side view 64. According to one embodiment, the model views 62, 64 may be displayed on a computer, tablet, or mobile device (such as device 22), as discussed elsewhere herein. In Figure 4A, the patient is walking with the right leg moving forward in a hip flexion motion, and right leg sensors 60A, 60C track that motion as reflected by the motion of the model in Figure 4B. Further, in Figure 5A, the patient's right leg transitions into a right knee flexion motion, with right leg sensors 60A, 60B tracking that motion as reflected by the motion of the model in Figure 5B. Thus, the various sensors 60A-60E enable tracking of all of the patient's standing, walking, and / or running motions, which can then be reflected in the motion of the electronic model in a manner similar to that described above.

[0046] In various embodiments, the virtual biomechanical model can be "fitted" to a particular patient using a system (such as system 10) by registering certain basic anthropometric parameters of the subject into the system, including, but not limited to, the subject's height, the subject's weight, gender, etc.

[0047] As a result, various system embodiments herein (such as system 10 described above) may be used in a variety of use cases related to improving (and in some exemplary cases, including rehabilitation) sensory motor function through sensory stimulation in patients with lower limb trauma, lower limb loss, or other dysfunction such as stroke or other neurological condition or disease.

[0048] For example, in one embodiment as shown in FIGS. 6A-6C, a walking patient can utilize a system according to embodiments herein (such as system 10) in the following manner. The patient can wear a set of sensors similar to sensors 12A, 12B, 14A-14E in system 10 described above. As shown in FIG. 6A, during use by the patient, a system (such as system 10) can track and calculate the patient's center of pressure 70 and center of mass 72, as shown. Furthermore, while the patient is walking as shown in FIG. 6B, the patient takes a step with the right foot too narrow, such that footpad 12A and sensors 14A, 14B associated with the right foot detect a right heel strike that may be too inward. Therefore, the system transmits a signal in real time to right tactile stimulation unit 16A indicative of the narrow step to the patient's nervous system, as shown in FIG. 6C.

[0049] Additionally, various system embodiments herein (such as system 10) can be used to monitor and provide sensory stimuli related to a variety of activities, including, but not limited to, static standing weight bearing with vibration gradients for intensity, step length for better symmetry, balance during weight transfer, and toe loading and / or timing of end stance during walking. In further implementations, the system can be used to monitor and provide stimuli for a variety of other physical activities involving lower limb and body position control and / or balance.

[0050] According to further embodiments, the system can have a variety of exemplary sensory stimulation modes that can be used to treat different patients. Table 1 below provides an exemplary, non-exhaustive list of such treatment modes. [Table 1]

[0051] For example, according to one exemplary embodiment as shown in Figure 7, a system (such as system 10) may be used to perform a method for tracking a patient's weight shift and provide stimulation 80 therefor. Specifically, the treatment mode in this particular implementation may be "Weight Shift-Basic" as described in the first row of Table 1 above.

[0052] In certain embodiments, the first step of method 80 is to input default parameters into the system (block 82). Such parameters may include, for example, duration of stimulation, target weight distribution, type of stimulation (e.g., continuous vs. repetitive), and / or whether the stimulation is positive or negative, among other potential parameters. In one embodiment, the default parameters are input by a clinician via an application on a mobile device (e.g., device 22 as described above) (block 82). Alternatively, the default parameters may be input by a system administrator or other individual. In a further implementation, the default parameters are input via any known interface when the system (e.g., system 10) is initially set up by a medical facility, clinician, or patient. In yet another alternative, the default parameters are built into the system.

[0053] Once the default parameters have been entered, or as a first step in embodiments where default parameters have been previously entered, the clinician can then enter the clinician's preferred parameters (block 84). Such parameters can include, for example, any of the default parameters described above. Thus, the clinician (or any other user) can incorporate their own preferred parameters for a particular patient or use that override the existing default parameters. Alternatively, the clinician or other user can choose to use the default parameters (and thus not enter any new / different parameters).

[0054] Once the preferred parameters have been established, the next step is to begin operation of the system by attaching sensors / devices to the patient and tracking the patient's movements / activity (block 86). In this particular embodiment, the patient is standing and weight transfer between the patient's two legs is tracked as described above.

[0055] Once the system is activated, data is collected from sensors (e.g., sensors in the foot pads, such as those in foot pad units 12A, 12B, and / or motion and angle sensors, such as those in sensors 14A-14E) (block 88). For example, in one implementation in which the lumbar sensor (e.g., sensor 14E) includes a local processing unit (e.g., processing unit 20), the foot pad sensors (e.g., foot pad units 12A, 12B) collect force and / or pressure data and transmit it to the lumbar sensor (e.g., sensor 14E). That is, the sensors in the left and right foot pads (e.g., those in units 12A, 12B) track the amount of force applied thereto based on the patient's posture. As the patient shifts their weight from one foot to the other, their weight distribution shifts accordingly, and the sensors in foot pad units 12A, 12B track that movement and transmit that data to the local processing unit 20. At this point, the local processing unit (such as processing unit 20) can process the information and perform calculations as discussed below with respect to method 80. Alternatively, lumbar sensor 14E and / or local processing unit 20 can transmit data to central processing unit 18 so that central processing unit 18 can process the information and perform calculations.

[0056] At this point, the collected data is used to calculate the patient's weight distribution, and therefore center of gravity, based on the sensor data (block 90). That is, data from sensors in the left and right foot pads (e.g., foot pads of units 12A, 12B) is collected, combined, and processed by local processing unit 20 (and / or central processing unit 18) to calculate the patient's center of gravity at any given time.

[0057] Once the patient's weight distribution / center of gravity is calculated, the data is compared to the target weight distribution / center of gravity to identify the difference (if any) therebetween and, based thereon, calculate the stimulation unit activation period (block 92). That is, first, the difference between the actual weight distribution and the target distribution is calculated. As a result, the data can be used to track any shifts in the center of gravity, including any shifts from the target weight distribution or center of gravity location. That is, any movement of the patient's weight distribution away from or toward the desired weight distribution / center of gravity can be calculated based on the collected data and the preset target weight distribution / center of gravity. Once the difference is calculated, that information is used to determine the activation period of the stimulation unit. In other words, the amount of the difference determines the activation period. For example, the greater the difference, the farther the actual center of gravity is from the target center of gravity (the farther the patient is moving their weight from the target center of gravity). The activation period of the stimulation unit then depends on the distance between the actual center of gravity and the target center of gravity. For example, in one embodiment, the greater the distance, the longer the activation period (and thus the longer duration and / or greater intensity of stimulation provided to the patient at the stimulation unit). Alternatively, the greater the distance, the shorter the activation period (and thus the greater number of activations, vibrations, beeps, etc. over a shorter period of time provided to the patient at the stimulation unit). In any of the embodiments herein, parameters provided by the system (default parameters) or parameters provided by a clinician or other user as described above are used as part of the calculation to determine the activation period.

[0058] In one particular exemplary implementation, a predetermined threshold of movement is set in the parameters such that the calculation triggers activation when the patient shifts weight to one leg or the other by a sufficient amount to exceed that threshold. In such an embodiment, a target weight distribution / center of gravity range may be set such that the system will not cause activation of the stimulation unit as long as the patient remains within that target range ("balance deadband"). Thus, the calculation only triggers activation of the stimulation unit when a threshold beyond the target range is reached and / or exceeded.

[0059] Furthermore, the calculations can also be used to determine which of the two stimulation units 16A, 16B to activate to provide sensory stimulation. That is, according to preset parameters, the stimulation unit 16A / 16B on the leg where the patient's weight is shifted more can be activated to provide stimulation. Alternatively, the preset parameters can be set so that the unit 16A / 16B on the leg where the weight is shifted less can be activated.

[0060] Once the activation period has been calculated, the calculation is used to transmit an appropriate signal from the local processing unit 20 (or central processing unit 18) to activate the stimulation units 16A, 16B (or appropriate units 16A / 16B) according to the parameters and as determined by the calculations discussed above (block 94).

[0061] Alternatively, the same or similar processes may be used to implement any of the sensory stimulation modes listed in Table 1 above, or any other sensory stimulation mode disclosed or contemplated herein. Additionally, it should be noted that if a particular sensory stimulation mode (such as any of those listed in Table 1) uses only a subset of the various system components as disclosed or contemplated herein, then only those components utilized need be incorporated into the physical system and worn by the patient.

[0062] According to certain implementations, a system (such as system 10) can operate in conjunction with a mobile device (such as device 22), such as a smartphone. For example, as shown in Figures 8A and 8B, an application is provided on the smartphone having a user interface capable of displaying a human model (as best shown in Figure 8B) in a manner similar to the graphical user interfaces discussed in more detail above and depicted in Figures 3B, 4B, and 5B. The smartphone (such as mobile device 22) can communicate wirelessly with a system (such as system 10) by communicating with a central processing unit (such as processing unit 18) and / or a local central processing unit (such as processing unit 20).

[0063] FIG. 8A depicts an application display in which timing characteristics and other details about the patient are provided at the top of screen 100, and the bottom of screen 102 displays the following points of interest: front and back of both feet, center of pressure of both feet, projection of the anterior superior iliac spine ("ASIS") and posterior superior iliac spine ("PSIS") points of the pelvis onto the floor, center of mass calculated by the model, and a real-time top view of the composite center of pressure calculated by the model.

[0064] 8B depicts an application display in which the upper part of screen 104 is a real-time top view of two insoles with the center of pressure for each insole, and the lower part of screen 106 shows real-time front and side views of the full model showing the motion of the body segment of interest.

[0065] 9 is a block diagram depicting a more detailed example of a computing device configured to perform the techniques described herein. Computing device 210 of FIG. 9 is described below as an example of a computing device that may be used in combination with or in place of computing device 22, server 26, and network 24 discussed above, and may comprise or include central processing unit 18 and / or processing unit 20 of FIG. 1. FIG. 9 depicts only one particular example of computing device 210, and many other examples of computing device 210 (e.g., device 22 and associated server(s) 26 and network 24, etc.) may be used in other cases and may include a subset of the components included in exemplary computing device 210 or may include additional components not shown in FIG. 9.

[0066] Computing device 210 may be any computer having the processing power required to properly perform the techniques described herein. For example, computing device 210 may be any one or more of a mobile computing device (e.g., a smartphone, a tablet computer, a laptop computer, etc.), a desktop computer, a smart home component (e.g., a computerized appliance, a home security system, a control panel for home components, a lighting system, a smart power outlet, etc.), a vehicle, a wearable computing device (e.g., a wearable sensor providing sensory stimulation for balance, a smart watch, computerized glasses, a heart monitor, a glucose monitor, smart headphones, etc.), a virtual reality / augmented reality / extended reality (VR / AR / XR) system, a video game or streaming system, a network modem, a router, or a server system, or any other computerized device that may be configured to perform the techniques described herein.

[0067] 9, computing device 210 includes a user interface component (UIC) 212, one or more processing units 240, one or more communication units 242, one or more input components 244, one or more output components 246, and one or more storage components 248. UIC 212 includes display component 202 and presence-responsive input component 204. Storage component 248 of computing device 210 includes communication module 220, analysis module 222, and data store 226.

[0068] 1 , and / or may perform similar functions. In this manner, one or more processing devices 240 may implement functions and / or execute instructions associated with computing device 210 to analyze pressure sensor readings and angle sensor readings to provide sensory stimuli. That is, processing device 240 may implement functions and / or execute instructions associated with computing device 210 to receive and process pressure sensor and angle signals and generate and output sensory stimulus signals.

[0069] Examples of processing unit 240 include any combination of processing units, processing units, or any other hardware configured to function as a processing unit, processing device, including an application processing unit, a display controller, an auxiliary processing unit, one or more sensor hubs, and a dedicated graphical processing unit (GPU). Modules 220 and 222 may be operable by processing unit 240 to perform various actions, operations, or functions of computing device 210. For example, processing unit 240 of computing device 210 may retrieve and execute instructions stored by memory component 248 that cause processing unit 240 to perform the operations described with respect to modules 220 and 222. The instructions, when executed by processing unit 240, may cause computing device 210 to analyze pressure sensor and angle measurements to provide sensory stimuli.

[0070] Communications module 220 may execute locally (e.g., in processing unit 240) to provide functionality associated with receiving signals from one or more sensors (e.g., force sensors, pressure sensors, motion sensors, and / or angle sensors) and outputting signals to the sensory stimulation unit. In some examples, communications module 220 may act as an interface to a remote service accessible to computing device 210. For example, communications module 220 may be an interface or application programming interface (API) to a remote server that receives signals from one or more sensors (e.g., force sensors, pressure sensors, motion sensors, and / or angle sensors) and outputs signals to the sensory stimulation unit.

[0071] In some examples, the analysis module 222 may execute locally (e.g., on the processing unit 240) to provide functionality related to analyzing data received by the communication module 220 to accurately generate a patient-specific virtual biomechanical model, generate an estimated center of pressure and center of gravity, and generate a balance stimulation signal based on the estimated center of pressure and center of gravity. In some examples, the analysis module 222 may function as an interface to a remote service accessible to the computing device 210. For example, the analysis module 222 may be an interface or application programming interface (API) to a remote server that analyzes data received by the communication module 220 to accurately generate a patient-specific virtual biomechanical model, generate an estimated center of pressure and center of gravity, and generate a balance stimulation signal based on the estimated center of pressure and center of gravity.

[0072] One or more storage components 248 in computing device 210 may store information for processing during operation of computing device 210, including one or more patient-specific virtual biomechanical models (e.g., computing device 210 may store data accessed by modules 220 and 222 during execution on computing device 210). In some examples, storage component 248 is temporary memory, meaning that the primary purpose of storage component 248 is not long-term storage. Storage component 248 on computing device 210 may be configured for short-term storage of information as volatile memory, and thus does not retain stored content when power is turned off. Examples of volatile memory include random access memory (RAM), dynamic random access memory (DRAM), static random access memory (SRAM), and other forms of volatile memory known in the art.

[0073] The storage component 248 may also include one or more computer-readable storage media in some embodiments. In some embodiments, the storage component 248 may include one or more non-transitory computer-readable storage media. The storage component 248 may be configured to store a larger amount of information than typically stored by volatile memory. The storage component 248 may further be configured for long-term storage of information as a non-volatile memory space, and may retain information after power on / off cycles. Examples of non-volatile memory include magnetic hard disks, optical disks, floppy disks, flash memory, or forms of electrically programmable memory (EPROM) or electrically erasable programmable memory (EEPROM). The storage component 248 may store program instructions and / or information (e.g., data) associated with the modules 220 and 222 and the data store 226. The storage component 248 may include memory configured to store data or other information associated with the modules 220 and 222 and the data store 226.

[0074] Communication channel 250 may interconnect (physically, communicatively, and / or operatively) each of components 212, 240, 242, 244, 246, and 248 for inter-component communication. In some embodiments, communication channel 250 may include a system bus, a network connection, an inter-process communication data structure, or any other method for communicating data.

[0075] One or more communication units 242 of computing device 210 may communicate with external devices over one or more wired and / or wireless networks by transmitting and / or receiving network signals on one or more networks. Examples of communication units 242 include a network interface card (e.g., an Ethernet card, etc.), an optical transceiver, a radio frequency transceiver, a GPS receiver, a radio frequency identification (RFID) transceiver, a near field communication (NFC) transceiver, or any other type of device capable of transmitting and / or receiving information. Other examples of communication units 242 may include a shortwave radio, a cellular data radio, a wireless network radio, and a universal serial bus (USB) controller.

[0076] One or more input components 244 of computing device 210 may accept input. Examples of input are tactile input, audio input, and video input. In one embodiment, input components 244 of computing device 210 include a presence-responsive input device (e.g., a touch-sensitive screen, PSD), a mouse, a keyboard, a voice response system, a camera, a microphone, or any other type of device for detecting input from a human or a machine. In some embodiments, input components 244 may include one or more sensor components (e.g., sensors 252). Sensors 252 may be physically incorporated into computing device 210 or may communicate with computing device 210 via wired or wireless communications. The sensors 252 may include one or more biometric sensors (e.g., a fingerprint sensor, a retinal scanner, a voice input sensor / microphone, a facial recognition sensor, a camera), one or more location sensors (e.g., a GPS component, a Wi-Fi component, a cellular component), one or more temperature sensors, one or more motion sensors (e.g., an accelerometer, a gyro), one or more pressure sensors (e.g., a barometer or force sensor), one or more ambient light sensors, and one or more other sensors (e.g., an infrared proximity sensor, a hygrometer sensor, etc.), to name a few other non-limiting examples, the other sensors may include a force sensor, a pressure sensor, a motion sensor, an angle sensor, a radar sensor, a lidar sensor, a sonar sensor, a heart rate sensor, a magnetometer, a glucose sensor, an olfactory sensor, a compass sensor, or a step counter sensor.

[0077] One or more output components 246 of computing device 210 may generate output in a selected modality. Example modalities may include tactile, audible, visual, machine-generated voice, or other modalities. In one example, output components 246 of computing device 210 may include a presence-responsive display, a sound card, a video graphics adapter card, a speaker, a cathode ray tube (CRT) monitor, a liquid crystal display (LCD), a light-emitting diode (LED) display, an organic light-emitting diode (OLED) display, a virtual / augmented / extended reality (VR / AR / XR) system, a three-dimensional display, or any other type of device for generating output to a human or machine in a selected modality.

[0078] The UIC 212 of computing device 210 includes a display component 202 and a presence-responsive input component 204. The display component 202 may be a screen, such as any of the displays or systems described with respect to output component 246, on which information (e.g., visual indications) is displayed by the UIC 212, while the presence-responsive input component 204 may detect objects at and / or near the display component 202.

[0079] Although shown as an internal component of computing device 210, UIC 212 may also represent an external component that shares a data path with computing device 210 for transmitting and / or receiving inputs and outputs. For example, in one embodiment, UIC 212 represents a built-in component of computing device 210 that is located within and physically connected to the external packaging of computing device 210 (e.g., a screen on a mobile phone). In another embodiment, UIC 212 represents an external component of computing device 210 that is located outside of and physically separate from the packaging or housing of computing device 210 (e.g., a monitor, projector, etc. that shares a wired and / or wireless data path with computing device 210).

[0080] The UIC 212 of the computing device 210 may detect two-dimensional and / or three-dimensional gestures as input from a user of the computing device 210. For example, a sensor of the UIC 212 may detect a user movement (e.g., moving a hand, arm, pen, stylus, tactile object, etc.) within a threshold distance of the sensor of the UIC 212. The UIC 212 may determine a two-dimensional or three-dimensional vector representation of the movement and correlate the vector representation to a gesture input having multiple dimensions (e.g., a hand wave, pinch, clap, pen stroke, etc.). In other words, the UIC 212 can detect a multi-dimensional gesture without the user having to perform the gesture on or near a screen or surface on which the UIC 212 outputs information for display. Instead, the UIC 212 can detect a multi-dimensional gesture performed on or near a sensor that may or may not be located near a screen or surface on which the UIC 212 outputs information for display.

[0081] In accordance with the techniques of the present disclosure, the communication module 220 may receive force and / or pressure signals from at least one force and / or pressure sensor associated with the patient's at least one lower limb or prosthetic limb, the force and / or pressure signals including force and / or pressure information related to the lower limb or prosthetic limb. The communication module 220 may further receive motion and / or angle signals from at least one motion and / or angle sensor associated with the patient's at least one lower limb or prosthetic limb, the motion and / or angle information related to the lower limb or prosthetic limb. The analysis module 222 may generate a patient-specific virtual biomechanical model stored in the data store 226 based on the force and / or pressure signals and the motion and / or angle signals to generate an estimated center of pressure and center of gravity. The analysis module 222 may further generate a balance stimulation signal based on the estimated center of pressure and center of gravity. The communication module 220 may output the balance stimulation signal to at least one sensory stimulation unit disposed on at least one lower limb or prosthetic limb of the patient, the at least one sensory stimulation unit comprising at least two stimulators operable to provide stimulation to the patient based on the balance stimulation signal.

[0082] The techniques of the present disclosure may be used to more effectively assist people suffering from conditions that affect a patient's ability to sense force, pressure, movement, or angles with their limbs. For example, a person with a lower limb injury or amputation or certain diseases may not be able to properly ascertain forces on certain parts of their body. By utilizing a computing device 210 to communicate with sensors that collect force, pressure, movement, and / or angle information, analyze that information, and output sensory stimulation signals to a sensory stimulation unit that provides sensory stimulation to the patient in other parts of the patient's body, the patient may be more able to walk and balance independently, reducing further injury or sensation that may otherwise result from a lack of balance.

[0083] Although the various systems described above are separate implementations, any of the individual components, mechanisms, or devices, and associated features and functionality within the various system embodiments described in detail above may be incorporated into any of the other system embodiments herein.

[0084] As used herein, the terms "about" and "substantially" refer to variations (including numerical quantities or structures) that may occur through typical measurement techniques and equipment with respect to any quantifiable variable, including, but not limited to, mass, volume, time, distance, wavelength, frequency, voltage, current, and electromagnetic fields. Additionally, there are likely certain random errors and variations in the real world due to differences in the manufacture, source, or precision of components used to make various components or perform methods, etc. The terms "about" and "substantially" also encompass these variations. The terms "about" and "substantially" can include any variation of 5% or 10%, or any amount between 0% and 10%, including any integer. Furthermore, the claims, whether modified by the terms "about" or "substantially," include the equivalent of the quantity or amount.

[0085] Numerical ranges recited herein are inclusive of the numbers defining the range and include each integer within the defined range. Throughout this disclosure, various aspects of the disclosure are presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges, fractions, and individual values ​​within that range. For example, the description of a range such as 1 to 6 should be considered to have specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numbers within that range, e.g., 1, 2, 3, 4, 5, and 6, and decimals and fractions, e.g., 1.2, 3.8, 1 1 / 2, and 4 3 / 4. This applies regardless of the breadth of the range. While various embodiments have been described with reference to preferred implementations, those skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope thereof.

[0086] Although various embodiments have been described with reference to preferred implementations, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope thereof.

Claims

1. 1. A system for improving sensorimotor function in a patient, the system comprising: (a) at least one force and / or pressure sensor associated with at least one lower limb or prosthetic limb of the patient, the at least one force and / or pressure sensor configured to detect force and / or pressure information related to the lower limb or prosthetic limb and transmit a force and / or pressure signal based on the force and / or pressure information; (b) at least one motion and / or angle sensor associated with at least one lower limb or prosthetic limb of the patient, the at least one motion and / or angle sensor configured to detect motion and / or angle information related to the lower limb or prosthetic limb and to transmit a motion and / or angle signal based on the motion and / or angle information; (c) a processing unit configured to receive the force and / or pressure signals and the movement and / or angle signals, generate a patient-specific virtual biomechanical model based on the force and / or pressure signals and the movement and / or angle signals, generate an estimated center of pressure and center of gravity, and generate a balance stimulus signal based on the estimated center of pressure and center of gravity; (d) at least one sensory stimulation unit disposed on at least one lower limb or prosthetic limb of the patient, the at least one sensory stimulation unit comprising at least two stimulators operable to provide stimulation to the patient based on the balance stimulation signal.

2. 10. The system of claim 1, wherein a first of the at least one force and / or pressure sensor is associated with a first pad, the first pad being disposable under the patient's first foot or prosthetic foot.

3. 3. The system of claim 2, wherein a second of the at least one force and / or pressure sensor is associated with a second pad, the second pad being disposable under the patient's second leg or prosthetic leg.

4. The system of claim 1 , wherein the at least one motion and / or angle sensor comprises five motion and / or angle sensors.

5. The system of claim 4 , wherein each of the five motion and / or angle sensors is an inertial motion unit located within a sensor processing module.

6. 2. The system of claim 1, wherein the at least one sensory stimulation unit comprises a first stimulation unit disposed on a first lower limb or prosthetic limb of the patient and a second stimulation unit disposed on a second lower limb or prosthetic limb of the patient.

7. The system of claim 1 , wherein the at least one sensory stimulation unit comprises four stimulators.

8. The system of claim 1 , further comprising a user interface operably coupled to the processing unit, the user interface configured to display the patient-specific virtual biomechanical model.

9. The system of claim 8 , wherein the user interface comprises an application within a mobile device.

10. The system of claim 9 , wherein the mobile device comprises a laptop or a smartphone.

11. 1. A system for improving sensorimotor function in a patient, the system comprising: (a) at least one force and / or pressure sensor associated with at least one lower limb or prosthetic limb of the patient, the at least one force and / or pressure sensor configured to detect force and / or pressure information related to the lower limb or prosthetic limb and transmit a force and / or pressure signal based on the force and / or pressure information; (b) at least one motion and / or angle sensor associated with at least one lower limb or prosthetic limb of the patient, the at least one motion and / or angle sensor configured to detect motion and / or angle information related to the lower limb or prosthetic limb and to transmit a motion and / or angle signal based on the motion and / or angle information; (c) a processing unit configured to receive the force and / or pressure signals and the movement and / or angle signals, generate a patient-specific virtual biomechanical model based on the force and / or pressure signals and the movement and / or angle signals, generate an estimated center of pressure and center of gravity, and generate a balance stimulus signal based on the estimated center of pressure and center of gravity; (d) at least one sensory stimulation unit disposed on at least one lower limb or prosthetic limb of the patient, the at least one sensory stimulation unit comprising at least two stimulators operable to provide stimulation to the patient based on the balance stimulation signal; and (e) a user interface operably coupled to the processing device, the user interface configured to receive information from the processing device regarding the patient-specific virtual biomechanical model and to display the patient-specific virtual biomechanical model based on the information from the processing device.

12. 12. The system of claim 11, wherein a first of the at least one force and / or pressure sensor is associated with a first pad, the first pad being disposable under a first foot or prosthetic leg of the patient, and a second of the at least one force and / or pressure sensor is associated with a second pad, the second pad being disposable under a second foot or prosthetic leg of the patient.

13. 12. The system of claim 11, wherein the at least one motion and / or angle sensor comprises five motion and / or angle sensors, a first and a second motion and / or angle sensor positioned on a first lower limb or prosthetic limb of the patient, a third and a fourth motion and / or angle sensor positioned on a second lower limb or prosthetic limb of the patient, and a fifth motion and / or angle sensor positioned on the patient's lower back.

14. 14. The system of claim 13, wherein each of the five motion and / or angle sensors is an inertial motion unit disposed within a sensor processing module, and the fifth motion and / or angle sensor is operably coupled to a local central processing unit, the local central processing unit being in communication with the processing unit.

15. The at least one sensory stimulation unit comprises a first stimulation unit disposed on a first lower limb or prosthetic limb of the patient, and a second stimulation unit disposed on a second lower limb or prosthetic limb of the patient, each of the first and second stimulation units comprising: (a) a band configured to be connectable to a lower limb or prosthetic limb; (b) the at least two stimulators including four stimulators attached to the band; (c) one of the at least one motion and / or angle sensor associated with one of the four stimulators.

16. The system of claim 11 , wherein the user interface comprises an application within a mobile device, the mobile device comprising a laptop or a smartphone.

17. 1. A system for improving sensorimotor function in a patient, the system comprising: (a) a first foot pad unit comprising a first foot pad comprising at least one first force and / or pressure sensor positionable under a first foot or prosthetic leg of a first lower limb or prosthetic limb of a patient, and a second foot pad unit comprising at least one second force and / or pressure sensor positionable under a second foot or prosthetic leg of a second lower limb or prosthetic limb of the patient, wherein each of the at least one first and second force and / or pressure sensor is configured to detect force and / or pressure information relating to the first and second lower limbs or prosthetic limbs, respectively, and to transmit a force and / or pressure signal based on the force and / or pressure information; (b) first and second sensor processing modules comprising at least one first motion and / or angle sensor associated with the first lower limb or prosthetic limb of the patient, third and fourth sensor processing modules comprising at least one second motion and / or angle sensor associated with the second lower limb or prosthetic limb of the patient, and a fifth sensor processing module comprising at least one third motion and / or angle sensor associated with a lumbar spine of the patient, wherein each of the at least one first, second, and third motion and / or angle sensor is configured to detect motion and / or angle information and transmit a motion and / or angle signal based on the motion and / or angle information; (c) a processing unit configured to receive the force and / or pressure signals and the movement and / or angle signals, generate a patient-specific virtual biomechanical model based on the force and / or pressure signals and the movement and / or angle signals, generate an estimated center of pressure and center of gravity, and generate a balance stimulus signal based on the estimated center of pressure and center of gravity; (d) at least one sensory stimulation unit disposed on at least one lower limb or prosthetic limb of the patient, the at least one sensory stimulation unit comprising at least two stimulators operable to provide stimulation to the patient based on the balance stimulation signal; and (e) a user interface operably coupled to the processing device, the user interface configured to receive information from the processing device regarding the patient-specific virtual biomechanical model and to display the patient-specific virtual biomechanical model based on the information from the processing device.

18. The system of claim 17 , wherein the fifth sensor processing module comprises a local central processing unit, the local central processing unit in communication with the processing unit.

19. The at least one sensory stimulation unit comprises: (a) a first stimulation unit positioned on the first limb or prosthetic limb of the patient, (i) a first band configured to be connectable to the first limb or prosthetic limb; (ii) four first stimulators attached to the first band; (iii) a first stimulation unit comprising one of the first and second sensor processing modules associated with one of the four stimulation devices; (b) a second stimulation unit disposed on the second limb or prosthetic limb of the patient, (i) a second band configured to be connectable to the second limb or prosthetic limb; (ii) four second stimulators attached to the second band; 18. The system of claim 17, comprising: (iii) a second stimulation unit comprising one of the third and fourth sensor processing modules associated with one of the four stimulation devices.

20. The system of claim 17 , wherein the user interface comprises an application within a mobile device, the mobile device comprising a laptop or a smartphone.

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