Sensory regulation system for improved gait function and / or balance control

Abstract

Systems for improving sensorimotor function in a patient, where the various systems may include: at least one force and / or pressure sensor associated with at least one lower limb or prosthesis of the patient; at least one motion and / or angle sensor associated with at least one lower limb or prosthesis of the patient; a processor configured to receive the force and / or pressure signals and the motion and / or angle signals, and to generate an estimated center of pressure and center of gravity, and to generate a balanced 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 or prosthesis of the patient, wherein the at least one sensory stimulation unit comprises at least two stimulators that are actuatable to provide stimulation to the patient based on the balanced stimulation signal.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 405,115, filed on September 9, 2022, and entitled “Sensory Modulation System for Improving Balance Control,” under 35 U.S.C. §119(e), which is hereby incorporated by reference in its entirety. Technical Field

[0003] Various embodiments herein relate generally to systems for improving at least one of balance control and gait function, and more particularly to devices that measure pressure and / or force related information and generate sensory stimuli or notifications encoding the information. Background Art

[0004] Loss of balance and associated falls are significant issues for people with lower limb trauma and those who have undergone lower limb (LL) amputation. This often results in reduced activity, reduced participation in social activities, and increased fear of falling. In fact, 52.4% of lower limb amputees report falling in the previous year, and 66% of above-knee amputees report falling annually, which is twice the rate of able-bodied adults over 65 years old. Falls can have a significant impact on subsequent morbidity, disability, and mortality risk. Falls in amputees can also have serious consequences for residual limb and prosthesis damage, as well as leading to a lack of confidence in and frequent discontinuation of use of a particular prosthesis.

[0005] Warfighters with lower extremity trauma and / or loss are often young and highly capable at the time of their injury. These individuals may be at increased risk for falls following rehabilitation from their injuries due to their continually active lifestyles, which sometimes include active duty and deployments. Even after participating in advanced rehabilitation and receiving state-of-the-art prosthetic and orthotic devices, warfighters with lower extremity trauma and / or loss remain at risk for falls.

[0006] Young and older individuals with amputations have similar overall falls risk. Younger service members are at risk due to the more challenging activities they perform, while older adults (including individuals seen in the Veterans Health Administration (VHA) system) have greater limitations in their ability to recover. Balance impairment and related falls are of greatest concern to older adults and individuals with amputations. Increasing age increases the consequences of falls and also decreases the ability to respond effectively to a loss of balance - increasing the importance of preventing and avoiding problematic loading conditions / body positions. Impairments in vision, strength, and cognition may develop with age as well as complex medical conditions, and all contribute to an increased risk of falls for older adults with amputations.

[0007] Common rehabilitation practices usually begin in a highly controlled environment and include basic gait and balance training activities on parallel bars to help the patient become familiar with their new sensory and motor abilities and the conditions associated with their limb / loss or trauma. This includes "trusting" their new limb and relearning to stand and walk. Activities progress gradually and become more difficult and may include activities specific to the warfighter's requirements.

[0008] Although previous studies on targeted fall mitigation training have demonstrated success, these interventions are often conducted on complex, cost-prohibitive systems, such as virtual environments with perturbation platforms and treadmills, which require extensive space and operator training. These systems are often not feasible for use in typical clinical treatment settings. Furthermore, it would be ecologically less plausible to conduct rehabilitation on a treadmill rather than in a more natural environment that includes sensory input from a visual stream. Furthermore, such systems lack important sensory stimuli, such as high-fidelity exteroceptive and proprioceptive information about limb load and position that are highly relevant to gait and balance function.

[0009] There is a need in the art for an improved sensory stimulation system for improving fall mitigation and / or intervention in patients with lower limb trauma or loss, as well as patients with neurodegenerative diseases that cause balance problems. Summary of the invention

[0010] Various systems, devices, and methods for improving sensorimotor function in a patient are discussed herein.

[0011] In Example 1, a system for improving a patient's sensory motor function includes: at least one force and / or pressure sensor associated with at least one lower limb or prosthesis of the patient, wherein the at least one force and / or pressure sensor is configured to detect force and / or pressure information related to the lower limb or prosthesis, and transmit a force and / or pressure signal based on the force and / or pressure information; at least one motion and / or angle sensor associated with at least one lower limb or prosthesis of the patient, wherein the at least one motion and / or angle sensor is configured to detect motion and / or angle information related to the lower limb or prosthesis, and transmit a motion and / or angle signal based on the motion and / or angle information; a processor configured to receive the force and / or pressure signal and the motion and / or angle signal, generate a patient-specific virtual biomechanical model based on the force and / or pressure signal and the motion and / or angle signal 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 or prosthesis of the patient, wherein the at least one sensory stimulation unit includes at least two stimulators, and the at least two stimulators are actuatable to provide stimulation to the patient based on the balance stimulation signal.

[0012] 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, wherein the first pad is positionable under a first foot or a prosthetic foot of the patient.

[0013] 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, wherein the second pad is positionable under a second foot or a prosthetic foot of the patient.

[0014] 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.

[0015] 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 within the sensor processing module.

[0016] Example 6 relates to a system according to Example 1, wherein the at least one sensory stimulation unit includes a first stimulation unit disposed on a first lower limb or a prosthesis of the patient and a second stimulation unit disposed on a second lower limb or a prosthesis of the patient.

[0017] Example 7 relates to a system according to Example 1, wherein at least one sensory stimulation unit includes four stimulators.

[0018] Example 8 relates to the system of Example 1, further comprising a user interface operably coupled to the processor, wherein the user interface is configured to display the patient-specific virtual biomechanical model.

[0019] Example 9 relates to the system of example 8, wherein the user interface comprises an application in the mobile device.

[0020] Example 10 relates to the system of Example 9, wherein the mobile device comprises a laptop computer or a smartphone.

[0021] In Example 11, a system for improving a patient's sensory motor function includes: at least one force and / or pressure sensor associated with at least one lower limb or prosthesis of the patient, wherein the at least one force and / or pressure sensor is configured to detect force and / or pressure information related to the lower limb or prosthesis, and transmit a force and / or pressure signal based on the force and / or pressure information; at least one motion and / or angle sensor associated with at least one lower limb or prosthesis of the patient, wherein the at least one motion and / or angle sensor is configured to detect motion and / or angle information related to the lower limb or prosthesis, and transmit a motion and / or angle signal based on the motion and / or angle information; a processor configured to receive the force and / or pressure signal and the motion and / or angle signal and / or angle signals, generating 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 generating a balance stimulation signal based on the estimated center of pressure and center of gravity; at least one sensory stimulation unit, which is arranged on at least one lower limb or prosthesis of the patient, wherein the at least one sensory stimulation unit includes at least two stimulators, and the at least two stimulators are actuatable to provide stimulation to the patient based on the balance stimulation signal; and a user interface, which is operably coupled to the processor, wherein the user interface is configured to receive information about the patient-specific virtual biomechanical model from the processor, and display the patient-specific virtual biomechanical model based on the information from the processor.

[0022] Example 12 relates to a system according to Example 11, wherein a first of the at least one force and / or pressure sensor is associated with a first pad, wherein the first pad is positionable under a first foot or a prosthetic foot of a patient, and a second of the at least one force and / or pressure sensor is associated with a second pad, wherein the second pad is positionable under a second foot or a prosthetic foot of the patient.

[0023] Example 13 relates to a system according to Example 11, wherein the at least one motion and / or angle sensor includes five motion and / or angle sensors, wherein a first motion and / or angle sensor and a second motion and / or angle sensor are disposed on a first lower limb or a prosthesis of the patient, a third motion and / or angle sensor and a fourth motion and / or angle sensor are disposed on a second lower limb or a prosthesis of the patient, and a fifth motion and / or angle sensor is disposed on the lower back of the patient.

[0024] Example 14 relates to a system according to Example 13, wherein each of the five motion and / or angle sensors is an inertial motion unit disposed within a sensor processing module, wherein the fifth motion and / or angle sensor is operably coupled to a local central processor, wherein the local central processor communicates with the processor.

[0025] Example 15 relates to a system according to Example 11, wherein at least one sensory stimulation unit includes a first stimulation unit disposed on a first lower limb or a prosthesis of the patient and a second stimulation unit disposed on a second lower limb or a prosthesis of the patient, wherein each of the first stimulation unit and the second stimulation unit includes a belt configured to be coupleable to the lower limb or the prosthesis, at least two stimulators including four stimulators attached to the belt, and at least one of the motion and / or angle sensors associated with one of the four stimulators.

[0026] Example 16 relates to the system of example 11, wherein the user interface comprises an application in a mobile device, wherein the mobile device comprises a laptop or a smartphone.

[0027] In Example 17, a system for improving a patient's sensory motor function includes: a first foot pad unit, which includes a first foot pad, the first foot pad including at least one first force and / or pressure sensor that can be positioned under the patient's first lower limb or a first foot or a prosthesis; and a second foot pad unit, which includes a second foot pad, the second foot pad including at least one second force and / or pressure sensor that can be positioned under the patient's second lower limb or a second foot or a prosthesis, wherein each of the at least one first force and / or pressure sensor and the at least one second force and / or pressure sensor is configured to respectively detect force and / or pressure information related to the first lower limb or prosthesis and the second lower limb or prosthesis, and transmit force and / or pressure signals based on the force and / or pressure information. The system further includes: a first sensor processing module and a second sensor processing module, which include at least one first motion and / or angle sensor associated with a first lower limb or a prosthesis of the patient; a third sensor processing module and a fourth sensor processing module, which include at least one second motion and / or angle sensor associated with a second lower limb or a prosthesis of the patient; and a fifth sensor processing module, which includes at least one third motion and / or angle sensor associated with the lower back of the patient, wherein each of the at least one first motion and / or angle sensor, the at least one second motion and / or angle sensor, and the at least one third motion and / or angle sensor is configured to detect motion and / or angle information, and transmit motion and / or angle signals based on the motion and / or angle information. The system also includes a processor, which is configured to receive force and / or pressure signals and 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 pressure center and center of gravity, and generate a balance stimulation signal based on the estimated pressure center and center of gravity. In addition, the system includes at least one sensory stimulation unit disposed on at least one lower limb or prosthesis of the patient, wherein the at least one sensory stimulation unit includes at least two stimulators, and the at least two stimulators are actuatable to provide stimulation to the patient based on the balance stimulation signal. And the system includes a user interface, which is operably coupled to the processor, wherein the user interface is configured to receive information about the patient-specific virtual biomechanical model from the processor, and display the patient-specific virtual biomechanical model based on the information from the processor.

[0028] Example 18 relates to the system of Example 17, wherein the fifth sensor processing module includes a local central processing unit, wherein the local central processing unit is in communication with the processor.

[0029] Example 19 relates to a system according to Example 17, wherein at least one sensory stimulation unit includes a first stimulation unit and a second stimulation unit. The first stimulation unit is disposed on a first lower limb or a prosthesis of the patient and includes a first band configured to be coupled to the first lower limb or the prosthesis, four first stimulators attached to the first band, and a first sensor processing module and a second sensor processing module associated with one of the four stimulators. The second stimulation unit is disposed on a second lower limb or a prosthesis of the patient and includes a second band configured to be coupled to the second lower limb or the prosthesis, four second stimulators attached to the second band, and a third sensor processing module and a fourth sensor processing module associated with one of the four stimulators.

[0030] Example 20 relates to the system of example 17, wherein the user interface comprises an application in a mobile device, wherein the mobile device comprises a laptop or a smartphone.

[0031] Although a number of 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 appreciated, the various embodiments are capable of modification in various obvious respects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 is a schematic depiction of a system for improving sensorimotor function in a patient according to one embodiment.

[0033] Figure 2A is a perspective view of a foot pad unit according to one embodiment.

[0034] Figure 2B is a perspective view of a tactile stimulation unit according to one embodiment.

[0035] Figure 3A is a schematic depiction of a standing patient wearing a set of sensory processing modules according to one embodiment.

[0036] Figure 3B For replication according to one embodiment Figure 3A An electronically generated reconstructed image of the human model of the patient's limbs.

[0037] Figure 4A According to one embodiment Figure 3A Schematic depiction of a patient with the patient placing her right leg forward while walking.

[0038] Figure 4B For replication according to one embodiment Figure 4AAn electronically generated reconstructed image of the human model of the patient's limbs.

[0039] Figure 5A According to one embodiment Figure 3A Schematic depiction of a patient with the patient lifting her right foot while walking.

[0040] Figure 5B For replication according to one embodiment Figure 5A An electronically generated reconstructed image of the human model of the patient's limbs.

[0041] Fig. 6A is a rear view of a patient wearing a force / pressure sensor and a motion / angle sensor while walking with his right leg forward, schematically depicting the calculation of the patient's center of pressure and center of mass, according to one embodiment.

[0042] Figure 6B According to one embodiment, when the patient places his right foot on the ground while walking Fig. 6A A posterior view of a patient is shown schematically illustrating the calculation of the patient's center of pressure and center of mass.

[0043] Figure 6C When the system provides stimulation to the patient based on the calculation of the center of pressure and the center of mass according to one embodiment Fig. 6A Rear view of the patient.

[0044] Figure 7 1 is a flow chart depicting the steps of a method of tracking a patient's movements / activities and providing stimulation to the patient based on those movements / activities according to one embodiment.

[0045] Fig. 8A and Figure 8B is a representative depiction of an interface of a mobile device according to one embodiment.

[0046] Fig. 9 is a schematic depiction of a computing device for use or combination with any system disclosed or contemplated herein, according to one embodiment. DETAILED DESCRIPTION

[0047] Various embodiments herein relate to systems and devices for providing relevant sensory stimulation to patients. More specifically, various systems and devices herein have force / pressure sensors and motion / angle sensors, which provide information to the processor, which in turn uses the information to provide real-time sensory stimulation related to the patient's balance and / or loss of balance to the patient. Additional system and device embodiments may include a patient-specific virtual model created by a system processor and / or system software to assimilate various forces / pressures / motions / angles and other balance parameters in order to produce fine and precise sensory stimulation for the patient. Certain embodiments may be used for fall relief training for patients with lower limb trauma or loss, including as part of rehabilitation care. That is, some of the various systems and device embodiments disclosed or contemplated herein may promote and / or enhance the sensory motor function of patients with lower limb trauma or loss, while other embodiments may be used to promote / enhance the sensory motor function of patients with other diseases (including, for example, neurological diseases, such as stroke). In addition, in certain exemplary embodiments, various systems and devices herein may promote and / or enhance the sensory motor function of patients in any environment and with any disease disclosed or contemplated herein.

[0048] exist Figure 1An exemplary system 10 according to one embodiment is schematically depicted in . This system 10 has two foot pad units 12A, 12B, wherein the right foot pad unit 12A has a foot pad positionable under a patient's right foot (or prosthesis) 30A, and the left foot pad unit 12B has a foot pad positionable under a patient's left foot (or prosthesis) 30B, wherein each of those foot pads of the foot pad units 12A, 12B has at least one force or pressure sensor. In addition, the system 10 also has five motion and angle sensors 14A, 14B, 14C, 14D, 14E, wherein the right foot sensor 14A is attached to or disposed near the right foot (or prosthesis) 30A, the left foot sensor 14B is attached to or disposed near the left foot (or prosthesis) 30B, the right leg sensor 14C is attached to or disposed near the right thigh (or prosthesis) 32A, the left leg sensor 14D is attached to or disposed near the left thigh (or prosthesis) 32B, and the lower back sensor 14E is attached to or disposed near the patient's lower waist area 34. In addition, the system 10 has two tactile sensory stimulation units 16A, 16B, wherein the right leg stimulation unit 16A is attached to the right thigh 32A and the left leg stimulation unit 16B is attached to the left thigh 32B. According to certain embodiments, the right leg sensor 14C and the left leg sensor 14D may be incorporated into the sensory stimulation units 16A, 16B, and the right foot sensor 14A and the left foot sensor 14B may be incorporated into the right foot pad unit 12A and the left foot pad unit 12B, as will be discussed in further detail below. Applicants should note that since patients with impaired limbs use various device / system embodiments herein, the use of the term foot or limb herein may also refer to any type of prosthesis or artificial limb. In addition, as used herein, the terms "prosthesis" and "prosthesis" are intended to have the same meaning and are interchangeable.

[0049] The system 10 also has a central processor 18, which is wirelessly coupled to the force / pressure sensors, motion / angle sensors 14A to 14E and tactile stimulation units 16A, 16B of the foot pad units 12A to 12B, so that information from the force / pressure sensors and motion / angle sensors 14A to 14E of the units 12A to 12B can be transmitted or otherwise transferred to the central processor 18, and the processor 18 can process the information and transmit the sensory stimulation instructions to the sensory stimulation units 16A, 16B, thereby providing sensory stimulation to the patient, as described in further detail below. That is, the central processor 18 uses the information from the sensors and sensors 14A to 14E of the units 12A to 12B to calculate when to activate the stimulation units 16A, 16B to provide sensory stimulation to the patient during use, as will be discussed in further detail below. In one embodiment, the stimulation units 16A, 16B provide sensory tactile stimulation in the form of vibration. Alternatively, the stimulation units 16A, 16B can provide any form of sensory stimulation.

[0050] In alternative embodiments, the system may have one sensory stimulation unit (including, for example, in the case where one of the two limbs is amputated or severely damaged). In other alternatives, three or more stimulation units may be used. According to other alternative embodiments, the number of motion / angle sensors may be one, two, three, four, six, seven, eight, nine, ten, or any other number of sensors that may be strategically positioned on the patient to collect information. According to additional alternatives, each of the sensors 14A to 14E may have a local processor associated with the sensors 14A to 14E so that each may perform local processing of the information collected by its respective sensor 14A to 14E.

[0051] In such Figure 1 In one specific alternative embodiment shown in FIG, the lower back sensor 14E has a local central processor 20 coupled thereto, which wirelessly communicates with the force / pressure sensors and other motion / angle sensors 14A to 14D in the foot pad units 12A, 12B, such that the local central processor 20 performs the central processing operations described above and communicates with the central processor 18 to transmit data and other information, as will be described in further detail below.

[0052] In addition, the system 10 may also have at least one computer or mobile device 22, which is coupled to the processor 18 and / or the processor 20 via a network 24, such as a local area network or the Internet 24. In addition, one or more servers 26 may also be coupled to the system 10 - directly coupled to the computer / mobile device 22 or through the network 24 - so that the server 26 can perform any of the processes disclosed or contemplated herein. As will be discussed elsewhere herein, the clinician can use the computer or mobile device 22 to set parameters for using the system 10 (or any system embodiment herein), as will be described in further detail herein, and / or receive results related to the use of the system by the patient. Alternatively, the computer or mobile device 22 can be used by the patient during use of the system 10 to input information into the system 10, and / or access information about the patient's use of the system 10 or analysis of such use generated by the system 10, as will be 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 cell phone such that the cell phone functions as a mobile device 22 that may be used to interface with the system 10 in the manner described above and elsewhere herein.

[0053] exist Figure 2AAn exemplary embodiment of a foot pad unit 12A / 12B is depicted in FIG. As noted above, each foot pad unit 12A, 12B has a foot pad 40A for placement under a patient's foot, the foot pad having at least one force / pressure sensor (not shown) disposed within / integrated with the foot pad 40A to sense the 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, an outer sensor, and an inner sensor. Alternatively, each foot pad 40A may have two, three, five, six, seven, eight, nine, ten, eleven, twelve, or any number of sensors as desired to track the center of pressure ("COP") associated with each foot of the patient. For example, in some embodiments, the foot pad 40A and / or the entire foot pad unit 12A, 12B may be a commercially available foot pad or may be used as a According to another embodiment, the foot pad 40A and / or the units 12A, 12B may be any of the foot pad or foot pad unit embodiments disclosed in U.S. Patent No. 8,974,402, issued on March 10, 2015 and entitled "Sensor Prosthetic for Improved Balance Control," which is incorporated herein by reference in its entirety. Each unit 12A / 12B also has a leg strap 40B that can be positioned around and attached to the patient's calf and a connector strap 40C that couples the strap 40B to the foot pad 40A. In the particular embodiment shown, each foot pad unit 12A / 12B has a local processor 42 coupled to the connector band 40C (or leg band 40B) so that the local processor 42 can receive signals from the pressure / force sensors in the foot pad 40A, process the signals, and transmit information related to those signals and processing to a central processor (e.g., central processor 18 and / or local central processor 20 as discussed above). In addition, each unit 12A / 12B can also have one of the motion and angle sensors 44, which is also coupled to the leg band 40B (or connector band 40C). For example, the motion and angle sensor 44 in the right unit 12A can be the sensor 14A discussed above, while the motion and angle sensor 44 in the left unit 12B can be the sensor 14B discussed above.

[0054] In certain embodiments, each footpad (e.g., footpad 40A in footpad units 12A, 12B) can provide foot pressure data for calculating the center of pressure ("COP"). That is, the exemplary footpad contains pressure sensors positioned at positions corresponding to the anatomical pressure distribution of the plantar surface of the foot. The rear sensor covers most of the pressure from the heel. The outer sensor covers the outside of the foot until the fifth metatarsal head. The front sensor is located at the sole of the foot between the first metatarsal head and the fifth metatarsal head. The inner sensor is located on the inside of the foot until the first metatarsal head, so that the sensor is loaded by both the first metatarsal head and the surface under the arch of the foot. Regardless of the number of pressure sensors and their positioning, the foot pressure amplitude and distribution data from these sensors can be used to estimate the patient's COP during activities such as standing and walking.

[0055] exist Figure 2B An exemplary embodiment of a tactile stimulation unit 16A / 16B is depicted in FIG. In this embodiment, the stimulation unit 16A / 16B has a band 50 having four vibrotactile actuators 52A, 52B, 52C, 52D strategically disposed about the band 50 such that they are positioned in anterior, posterior, medial, and lateral positions relative to the patient's leg. In certain embodiments, the tactile stimulation unit 16A / 16B may be a device that can be used as 8,974,402, which is incorporated by reference above. In addition, one of the actuators 52A as shown may also be a motion and angle sensor 52A also coupled to the belt 50. For example, the actuator 52A in the right tactile stimulation unit 16A may also be the motion and angle sensor 14C discussed above, while the actuator 52A in the left tactile stimulation unit 16B may also be the motion and angle sensor 14D discussed above.

[0056] According to some embodiments, 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. In addition, in certain embodiments as noted above, each of the motion / angle sensors (e.g., sensors 14A to 14E) in system 10 is incorporated into a unit that includes a local processor. This unit may be referred to herein as a sensor processing module ("SPM"), such that motion and angle sensors 14A to 14E are also SPMs 14A to 14E. The SPM can capture IMU data and provide local sensor fusion functionality and connectivity. An exemplary SPM embodiment has an IMU (e.g., 9-axis, such as Bosch BNO055), a microprocessor (e.g., an ARM Cortex-M4 with floating point hardware or the like), a wireless transceiver (e.g., Bluetooth Low Energy 5.0+), a battery (e.g., a lithium polymer or other high current output / low capacity battery required for motor activation), an analog input port (with amplification and filtering circuitry to read resistance from a foot sensor), a vibrotactile actuator (e.g., a linear resonant actuator), and drive circuitry for additional vibrotactile actuators coupled to the tactile stimulation unit, or any combination of these components / features. In addition, certain SPM embodiments will be able to perform wireless over-the-air (OTA) updates and configurations of firmware, fuse sensor information and transmit relevant data to other system modules, process model data and provide activation signals to other SPMs, provide power to the SPM itself and connected peripherals, provide amplitude and frequency modulated signals to drive actuators in the tactile stimulation unit, and read analog signals on at least 4 input channels, or any combination of these capabilities.

[0057] In certain embodiments, a central processor (e.g., central processor 18) may calculate patient-specific biomechanical model data (including an estimate of the patient's center of mass ("COM")), control system configuration, provide secure storage, and analyze data, or any combination thereof. The data collected to construct a patient-specific model (as discussed in further detail below) may be recorded and analyzed locally by the central processor. In addition, in various aspects, the central processor may additionally perform as a gateway to connect the system 10 to remote hardware (e.g., server 26 and / or computer / mobile device 22 discussed above) for analysis or downloading data for storage. In some embodiments, an application running on an off-the-shelf mobile device (e.g., device 22) such as a phone, tablet computer, or laptop computer may provide central processor functionality. That is, the central processor 18 may be wirelessly connected to a mobile device (e.g., device 22) so that the mobile device and the central processor may communicate. In certain embodiments, the central processor 18 may provide both gateway and control interface functionality to a clinician / technician or patient during a sensory stimulation exercise. In an exemplary embodiment, the central processor 18 can communicate with the SPMs 14A to 14E to retrieve and forward data for secure storage, display relevant usage data or live stream data from the system, calculate patient-specific models (real-time or offline), send stimulation activation parameters to the system 10, manage, configure and calibrate the SPMs 14A to 14E, or any combination of these actions. In a specific example, the central processor 18 can be a laptop computer or a mobile phone, such as a Samsung Galaxy S9.

[0058] In various embodiments, the communication between the central processor 18 and the SPMs 14A to 14E, between the SPMs 14A to 14E, and / or between the server, the computer / mobile device 22, the processor 18, and / or the processor 20 may be via a physical connection (wires) or via wireless communication. For example, the wireless communication may be BLE 5.0 (Bluetooth Low Energy). Alternatively, other known wireless technologies may be used, such as ANT, Thread, Zigbee, Wi-Fi, or proprietary protocols in the ISM band.

[0059] As mentioned above, in certain embodiments, system 10 may use an electronic full-body phantom, an exemplary version of which is shown in Figure 3B , Figure 4B and Figure 5B10 (and discussed in further detail below). In certain embodiments, system embodiments herein may utilize sensor information and generate models in real time. The models are generated from information from motion / angle sensors attached to the patient (e.g., sensors 14A to 14E discussed above with respect to system 10). Parameters that may be tracked by the motion / angle sensors may 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 models are written in Java, but may be created with any software.

[0060] exist FIG. 3A to FIG. 5B An example of an IMU for generating an electronic real-time full-body human model is shown in FIG. Figure 3A , IMUs 60A, 60B, 60C, 60D, 60E are positioned on a patient in order 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 right thigh in a manner similar to that described above with respect to FIG. Figure 1 Thus, the IMU 60A to 60E (such as the positioning Figure 3A The resulting model is Figure 3B In the display, Figure 3B A graphical user interface is depicted showing a human model, including a front view 62 and a side view 64. According to one embodiment, the views 62, 64 of the model may be displayed on a computer, tablet computer, or mobile device (e.g., device 22), as discussed elsewhere herein. Figure 4A In FIG. 1 , the patient is walking so that the right leg moves forward in a hip flexion motion, wherein the right leg sensors 60A, 60C track the motion so that it is Figure 4B In addition, Figure 5A In FIG. 1 , the patient's right leg moves into a right knee flexion movement, wherein the right leg sensors 60A, 60B track the movement so that it is reflected in Figure 5B Thus, the various sensors 60A to 60E make it possible to track all standing, walking and / or running movements of the patient so that the movements can be reflected in the movements of the electronic model in a similar manner as above.

[0061] In various embodiments, a system (e.g., system 10) may be used to "fit" a virtual biomechanical model to a particular patient by registering certain basic anthropometric parameters of interest (including but not limited to subject height, subject weight, gender, etc.) with the system.

[0062] Thus, the various system embodiments herein (e.g., system 10 described above) may be used for various use cases related to improving sensorimotor function (including, in some exemplary cases, for rehabilitation) via sensory stimulation of patients with lower limb trauma, lower limb loss, or other functional impairment (e.g., stroke or other neurological conditions or diseases).

[0063] For example, in FIG. 6A to FIG. 6C In one embodiment shown in FIG. 1 , a walking patient may utilize a system (e.g., system 10) according to embodiments herein in the following manner. The patient may wear a set of sensors similar to sensors 12A-12B, 14A-14E in system 10 described above. Fig. 6A As shown in , during use by a patient, a system (e.g., system 10) can track and calculate the patient's center of pressure 70 and center of mass 72, as shown. Figure 6B As shown in FIG. 1 , when the patient walks, the patient takes steps with his right foot that are too narrow, so that the foot pad 12A and sensors 14A, 14B associated with the right foot detect that the right heel strikes possibly too medially. Therefore, the system transmits a signal in real time to the right tactile stimulation unit 16A, which indicates a narrow step to the patient's nervous system, such as Figure 6C As shown in .

[0064] In addition, various system embodiments herein (e.g., system 10) can be used to monitor and provide sensory stimulation associated with various activities, including but not limited to the following: static stance weight bearing with vibration gradients of intensity, step length for better symmetry, balance during weight transfer, and end stance toe loading and / or timing during gait. In further embodiments, the system can be used to monitor and provide stimulation for various other physical activities involving lower extremity and postural control and / or balance.

[0065] According to further embodiments, the system may have various exemplary sensory stimulation modes that may be used to treat various patients. Table 1 below provides an exemplary, non-exhaustive list of such treatment modes.

[0066]

[0067]

[0068] Table 1

[0069] For example, according to Figure 7 In one exemplary embodiment shown in , a system (e.g., system 10) can be used to perform a method 80 of tracking a patient's weight shift and providing stimulation regarding weight shift. Specifically, the treatment mode in this particular embodiment can be "Weight Shift - Basic" as set forth in the first row of Table 1 above.

[0070] In certain embodiments, the first step of method 80 is to input default parameters into the system (frame 82). Such parameters may include, for example, the duration of stimulation, target weight distribution, the type of stimulation (continuous and repeated, etc.) and / or whether the stimulation is positive or negative, and other potential parameters. In one embodiment, default parameters (frame 82) are input by a clinician via an application on a mobile device (e.g., device 22 as discussed above). Alternatively, default parameters may be input by a system administrator or other individuals. In other embodiments, when the system (e.g., system 10) is first set by a health care facility, a clinician or a patient, default parameters are input via any known interface. In yet another alternative, default parameters are built into the system.

[0071] Once the default parameters have been entered, or as a first step in those embodiments where the default parameters have been previously entered, the clinician may then enter the clinician's preferred parameters (frame 84). Such parameters may include any of the default parameters discussed above, for example. Thus, the clinician (or any other user) may incorporate her own preferred parameters for a particular patient or use parameters that overwrite existing default parameters. Alternatively, the clinician or other user may choose to use the default parameters (and therefore not enter any new / different parameters).

[0072] Once the preferred parameters are established, the next step is to start operating the system by attaching the sensor / device to the patient and tracking the patient's movements / activities (frame 86). In this specific embodiment, the patient stands and tracks any weight transfer between the patient's legs, as noted above.

[0073] Once the system is activated, data from sensors including, for example, sensors in footpads (e.g., footpads in footpad units 12A, 12B) and / or motion and angle sensors (e.g., sensors 14A-14E) are collected (block 88). For example, in one embodiment where the lower back sensor (e.g., sensor 14E) includes a local processor (e.g., processor 20), the footpad sensors (e.g., in footpad units 12A, 12B) collect force and / or pressure data and transmit it to the lower back sensor (e.g., sensor 14E). That is, the sensors in the right and left footpads (e.g., footpads in units 12A, 12B) track the amount of force applied thereto based on the patient's posture. If the patient shifts her weight from one foot to the other, the weight distribution shifts accordingly, and the sensors in the footpad units 12A, 12B track the shift and transmit the data to the local processor 20. At this point, the local processor (e.g., processor 20) may process the information and perform calculations as discussed below with respect to this method 80. Alternatively, the lower back sensor 14E and / or the local processor 20 may transmit data to the central processor 18 so that the central processor 18 can process the information and perform calculations.

[0074] At this point, the collected data is used to calculate the weight distribution and, therefore, the patient's center of gravity based on the sensor data (block 90). That is, data from sensors in the right and left foot pads (e.g., the foot pads of units 12A, 12B) are collected, combined, and processed by the local processor 20 (and / or the central processor 18) to calculate the patient's center of gravity at any given time.

[0075] 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 the stimulation unit activation period is calculated based thereon (frame 92). That is, the difference between the actual weight distribution and the target distribution is first calculated. Thus, the data can be used to track any shift in the center of gravity, including any shift away from the target weight distribution or center of gravity position. 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, the 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 shifts her weight from the target center of gravity). And the activation period of the stimulation unit 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 greater the activation period (and therefore the longer the duration and / or the greater the intensity of the stimulation provided to the patient at the stimulation unit). Alternatively, the greater the distance, the shorter the activation period (and therefore the greater the number of activations (vibrations, beeps, etc.) provided to the patient in a shorter period of time 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 will be used as part of the calculation to determine the activation period.

[0076] In one specific exemplary embodiment, a predetermined movement threshold is set in the parameters, so that when the patient shifts her weight to one leg or the other by a sufficient amount to exceed said threshold, then the calculation triggers activation. In this embodiment, a target weight distribution / center of gravity range may be set, so that as long as the patient remains within said target range ("balance dead zone"), the system does not cause activation of the stimulation units. Thus, the calculation only causes activation of the stimulation units when the threshold exceeding the target range is hit and / or exceeded.

[0077] Furthermore, the calculation can also be used to determine which of the two stimulation units 16A, 16B is activated to provide the sensory stimulation. That is, according to the preset parameters, the stimulation unit 16A / 16B on the leg that has transferred more of the patient's weight can be activated to provide the stimulation. Alternatively, the preset parameters can be set so that the unit 16A / 16B on the leg that has transferred less weight can be activated.

[0078] Once the activation period has been calculated, the calculations are used to transmit appropriate signals from the local processor 20 (or central processor 18) to activate the stimulation units 16A, 16B (or appropriate units 16A / 16B) according to the parameters and determined by the calculations as discussed above (box 94).

[0079] Alternatively, the same or similar process may be used to perform any of the sensory stimulation modes listed in Table 1 above, or any other sensory stimulation mode disclosed or contemplated herein. In addition, it should be noted that if a certain sensory stimulation mode (e.g., any of the sensory stimulation modes set forth in Table 1) uses only a subset of the various system components as disclosed or contemplated herein, then only those components to be utilized need be incorporated into the physical system and worn by the patient.

[0080] According to certain embodiments, a system (e.g., system 10) may operate with a mobile device such as a smartphone (e.g., device 22). Fig. 8A and Figure 8B As shown in FIG. 1 , an application is provided for a smartphone, the application having a user interface, which can be similar to that discussed in further detail above and in Figure 3B , Figure 4B and Figure 5B The graphical user interface depicted in FIG. 1 displays a human model (eg, Figure 8B ). A smartphone (e.g., mobile device 22) may wirelessly communicate with a system (e.g., system 10) by communicating with a central processor (e.g., processor 18) and / or a local central processor (e.g., processor 20).

[0081] Fig. 8A The application display is depicted with timing characteristics and other details about the patient provided at the top of the screen 100, while the bottom of the screen 102 displays a real-time overhead view of the following points of interest: the front and back of both feet, the center of pressure of both feet, the projection of the anterior superior iliac spine ("ASIS") point and the posterior superior iliac spine ("PSIS") point from the pelvis onto the floor, the center of mass calculated by the model, and the combined center of pressure calculated by the model.

[0082] also, Figure 8B Depict application display, wherein screen top portion 104 is a real-time top view of two insoles, and each insole has a pressure center.In addition, screen bottom portion 106 shows a real-time front view and side view of the complete model, which shows the movement of the body segment concerned.

[0083] Fig. 9 A block diagram illustrating a more detailed example of a computing device configured to perform the techniques described herein. Fig. 9 The computing device 210 is described as being usable in combination with or in place of the computing device 22, server 26, and network 24 discussed above and may include or contain Figure 1 The CPU 18 and / or the processor 20 are examples of computing devices. Fig. 9Only one particular example of computing device 210 is illustrated, and many other examples of computing device 210 (e.g., device 22 and one or more associated servers 26 and network 24) may be used in other embodiments and may include a subset of the components included in the example computing device 210, or may include Fig. 9 Additional components not shown.

[0084] The computing device 210 may be any computer with sufficient processing power to perform the techniques described herein. For example, the computing device 210 may be any one or more of a mobile computing device (e.g., a smartphone, a tablet, a laptop, 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 that provides sensory stimulation for balance, a smart watch, computerized glasses, a heart monitor, a glucose monitor, a smart headset, etc.), a virtual reality / augmented reality / extended reality (VR / AR / XR) system, a video game or streaming system, a network modem, a router or server system, or any other computerized device that may be configured to perform the techniques described herein.

[0085] like Fig. 9 , computing device 210 includes a user interface component (UIC) 212, one or more processors 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 a display component 202 and a presence-sensitive input component 204. Storage component 248 of computing device 210 includes a communication module 220, an analysis module 222, and a data storage area 226.

[0086] The one or more processors 240 may be similar to and / or perform operations similar to Figure 1 In this manner, one or more processors 240 may implement functionality associated with computing device 210 and / or execute instructions associated therewith to analyze pressure sensor readings and angle sensor readings in order to provide sensory stimulation. In other words, processor 240 may implement functionality associated with computing device 210 and / or execute instructions associated therewith to receive and process pressure sensor signals and angle signals and generate and output sensory stimulation signals.

[0087] Examples of processor 240 include any combination of an application processor, a display controller, an auxiliary processor, one or more sensor hubs, and any other hardware configured to function as a processor, a processing unit, or a processing device, including a dedicated graphics processing unit (GPU). Modules 220 and 222 may be operated by processor 240 to perform various actions, operations, or functions of computing device 210. For example, processor 240 of computing device 210 may retrieve and execute instructions stored by storage component 248 that cause processor 240 to perform operations described with respect to modules 220 and 222. The instructions, when executed by processor 240, may cause computing device 210 to analyze pressure sensor readings and angle readings in order to provide sensory stimulation.

[0088] The communication module 220 may be executed locally (e.g., at the processor 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 the signals to the sensory stimulation unit. In some examples, the communication module 220 may act as an interface to a remote service accessible to the computing device 210. For example, the communication 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 the signals to the sensory stimulation unit.

[0089] In some examples, the analysis module 222 may be executed locally (e.g., at the processor 240) to provide functionality associated with analyzing data received by the communication module 220 so as to accurately generate a patient-specific virtual biomechanical model to generate an estimated center of pressure and center of gravity, and to generate a balance stimulation signal based on the estimated center of pressure and center of gravity. In some examples, the analysis module 222 may serve 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 the data received by the communication module 220 so as to accurately generate a patient-specific virtual biomechanical model to generate an estimated center of pressure and center of gravity, and to generate a balance stimulation signal based on the estimated center of pressure and center of gravity.

[0090] One or more storage components 248 within the computing device 210 may store information for processing during operation of the computing device 210 (e.g., the computing device 210 may store data accessed by the modules 220 and 222 during execution at the computing device 210), including one or more patient-specific virtual biomechanical models. In some instances, the storage component 248 is temporary storage, meaning that the primary purpose of the storage component 248 is not long-term storage. The storage component 248 on the computing device 210 may be configured as volatile memory for short-term storage of information, and thus the stored contents are not retained if power is removed. 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.

[0091] In some instances, storage component 248 also includes one or more computer-readable storage media. In some instances, storage component 248 includes one or more non-transitory computer-readable storage media. Storage component 248 may be configured to store a larger amount of information than is typically stored by volatile memory. Storage component 248 may be further configured to store information long-term as a non-volatile memory space and retain the information after a power on / off cycle. Examples of non-volatile memory include magnetic hard disks, optical disks, floppy disks, flash memory, or various forms of electrically programmable memory (EPROM) or electrically erasable programmable (EEPROM) memory. Storage component 248 may store program instructions and / or information (e.g., data) associated with modules 220 and 222 and data storage area 226. Storage component 248 may include a memory configured to store data or other information associated with modules 220 and 222 and data storage area 226.

[0092] Communication channel 250 may interconnect each of components 212, 240, 242, 244, 246, and 248 for inter-component communication (physically, communicatively, and / or operationally). In some examples, communication channel 250 may include a system bus, a network connection, an inter-process communication data structure, or any other method for transferring data.

[0093] One or more communication units 242 of computing device 210 may communicate with external devices via one or more wired and / or wireless networks by transmitting and / or receiving network signals over one or more networks. Examples of communication unit 242 include a network interface card (e.g., an Ethernet card), 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 that can send and / or receive information. Other examples of communication unit 242 may include a shortwave radio, a cellular data radio, a wireless network radio, and a universal serial bus (USB) controller.

[0094] One or more input components 244 of computing device 210 may receive input. Examples of input are tactile input, audio input, and video input. In one example, input component 244 of computing device 210 includes an 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 person or a machine. In some examples, input component 244 may include one or more sensor components (e.g., sensor 252). Sensor 252 may be physically incorporated into computing device 210, or may communicate with computing device 210 by wire or wirelessly. Sensor 252 may include one or more biosensors (e.g., a fingerprint sensor, a retinal scanner, a voice input sensor / microphone, a facial recognition sensor, a camera), one or more position 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 gyroscope), one or more pressure sensors (e.g., a barometer or a force sensor), one or more ambient light sensors, and one or more other sensors (e.g., an infrared proximity sensor, a hygrometer sensor, etc.). Other sensors may include force sensors, pressure sensors, motion sensors, angle sensors, radar sensors, lidar sensors, sonar sensors, heart rate sensors, magnetometers, glucose sensors, olfactory sensors, compass sensors, or step counter sensors, to name just a few other non-limiting examples.

[0095] One or more output components 246 of computing device 210 may generate output in the selected modality. Examples of modalities may include tactile notifications, auditory notifications, visual notifications, machine-generated voice notifications, or other modalities. In one example, output components 246 of computing device 210 include a presence-sensitive 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 LED (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 person or machine in the selected modality.

[0096] The UIC 212 of the computing device 210 includes a display component 202 and a presence-sensitive input component 204. The display component 202 can be a screen, such as any of the displays or systems described with respect to the output component 246, at which the UIC 212 displays information (e.g., visual indications), while the presence-sensitive input component 204 can detect objects at and / or near the display component 202.

[0097] Although illustrated as an internal component of the computing device 210, the UIC 212 may also represent an external component that shares a data path with the computing device 210 for transmitting and / or receiving input and output. For example, in one example, the UIC 212 represents a built-in component of the computing device 210 that is located within and physically connected to an external package of the computing device 210 (e.g., a screen on a mobile phone). In another example, the UIC 212 represents an external component of the computing device 210 that is located outside and physically separated from the package or housing of the computing device 210 (e.g., a monitor, projector, etc. that shares a wired and / or wireless data path with the computing device 210).

[0098] UIC 212 of computing device 210 may detect two-dimensional and / or three-dimensional gestures as input from a user of computing device 210. For example, a sensor of UIC 212 may detect a motion of a user (e.g., moving a hand, arm, pen, stylus, tactile object, etc.) within a threshold distance of the sensor of UIC 212. UIC 212 may determine a two-dimensional or three-dimensional vector representation of the motion and associate the vector representation with a gesture input having multiple dimensions (e.g., waving, pinching, clapping, pen strokes, etc.). In other words, UIC 212 may detect multi-dimensional gestures without requiring the user to perform the gesture at or near a screen or surface where UIC 212 outputs information for display. Instead, UIC 212 may detect multi-dimensional gestures performed at or near a sensor, which may or may not be located near a screen or surface where UIC 212 outputs information for display.

[0099] According to the technology of the present disclosure, the communication module 220 can receive the force and / or pressure signal containing the force and / or pressure information related to the lower limb or prosthesis from at least one force and / or pressure sensor associated with at least one lower limb or prosthesis of the patient. The communication module 220 can also receive the motion and / or angle signal containing the motion and / or angle information related to the lower limb or prosthesis from at least one motion and / or angle sensor associated with at least one lower limb or prosthesis of the patient. The analysis module 222 can generate the patient-specific virtual biomechanical model stored in the data storage area 226 based on the force and / or pressure signal and the motion and / or angle signal to generate and estimate the pressure center and center of gravity. The analysis module 222 can further generate a balance stimulation signal based on the pressure center and center of gravity estimated. The communication module 220 can output the balance stimulation signal to at least one sensory stimulation unit arranged on at least one lower limb or prosthesis of the patient, wherein at least one sensory stimulation unit includes at least two stimulators, and the at least two stimulators are actuatable to provide stimulation to the patient based on the balance stimulation signal.

[0100] When using the techniques of the present disclosure, people with conditions that affect the patient's ability to sense force, pressure, motion, or angle with their limbs can be more effectively helped. For example, people with lower limb injuries or amputations or certain diseases may not be able to correctly determine the forces on certain parts of their body. By utilizing the computing device 210 to communicate with sensors that collect force, pressure, motion, and / or angle information, analyze the information, and output sensory stimulation signals to a sensory stimulation unit that provides sensory stimulation to the patient at other parts of the patient's body, the patient can be more able to walk and balance on their own, thereby reducing further injuries that may be caused by lack of balance or sense they may have.

[0101] Although the various systems described above are separate implementations, any of the individual components, mechanisms or devices, and related features and functionality within the various system embodiments described in detail above may be incorporated into any of the other system embodiments herein.

[0102] As used herein, the terms "about" and "substantially" refer to changes (including in numerical quantity or structure) that can occur, for example, with respect to any quantifiable variable by typical measurement techniques and equipment, including but not limited to mass, volume, time, distance, wavelength, frequency, voltage, current, and electromagnetic field. In addition, in the real world, there are some unintentional errors and changes that may be caused by differences in the manufacture, source, or accuracy of components used to make various components or perform methods, etc. The terms "about" and "substantially" also cover these changes. The terms "about" and "substantially" may include any changes of 5% or 10%, or any amount between 0% and 10%, including any integer. In addition, whether or not modified by the terms "about" or "substantially", the claims include equivalents of quantity or amount.

[0103] The numerical ranges listed in the specification include the numbers defining the ranges, and include each integer within the defined ranges. Throughout this disclosure, various aspects of the disclosure are presented in range format. It should be understood that the description in range format is merely for convenience and brevity, and should not be interpreted as a fixed limitation on the scope of the disclosure. Therefore, the description of a range should be considered to have all possible sub-ranges, fractions, and individual values ​​within the range that are explicitly disclosed. For example, a description of a range such as 1 to 6 should be considered to have explicitly disclosed sub-ranges, 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 the range, such as 1, 2, 3, 4, 5, and 6, as well as decimals and fractions, such as 1.2, 3.8, 1 1 / 2 and 4 3 / 4. This applies regardless of the breadth of the range. Although various embodiments have been described with reference to preferred embodiments, those skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the present disclosure.

[0104] Although various embodiments have been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the present disclosure.

Claims

1. A system for improving sensory motor function of a patient, the system comprising: (a) at least one force and / or pressure sensor associated with at least one lower limb or prosthesis of the patient, wherein The at least one force and / or pressure sensor is configured to detect force and / or pressure information associated with the lower limb or prosthesis 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 prosthesis of the patient, wherein the at least one motion and / or angle sensor is configured to detect motion and / or angle information associated with the lower limb or prosthesis and transmit a motion and / or angle signal based on the motion and / or angle information; (c) a processor configured to receive the force and / or pressure signal and the motion and / or angle signal, generate a patient-specific virtual biomechanical model based on the force and / or pressure signal and the motion and / or angle signal 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 (d) at least one sensory stimulation unit, which is arranged on at least one lower limb or prosthesis of the patient, wherein The at least one sensory stimulation unit comprises at least two stimulators actuatable to provide stimulation to the patient based on the balanced stimulation signal.

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

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, wherein the second pad is positionable under the patient's second foot or prosthetic foot. 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 disposed within a sensor processing module.

6. 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 a prosthesis of the patient and a second stimulation unit disposed on a second lower limb or a prosthesis 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 processor, wherein the user interface is configured to display the patient-specific virtual biomechanical model.

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

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

11. A system for improving sensory motor function of a patient, the system comprising: (a) at least one force and / or pressure sensor associated with at least one lower limb or prosthesis of the patient, wherein The at least one force and / or pressure sensor is configured to detect force and / or pressure information associated with the lower limb or prosthesis 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 prosthesis of the patient, wherein the at least one motion and / or angle sensor is configured to detect motion and / or angle information associated with the lower limb or prosthesis and transmit a motion and / or angle signal based on the motion and / or angle information; (c) a processor configured to receive the force and / or pressure signal and the motion and / or angle signal, generate a patient-specific virtual biomechanical model based on the force and / or pressure signal and the motion and / or angle signal 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; (d) at least one sensory stimulation unit, which is arranged on at least one lower limb or prosthesis of the patient, wherein The at least one sensory stimulation unit comprises at least two stimulators, the at least two stimulators being actuatable to provide stimulation to the patient based on the balanced stimulation signal; and (e) a user interface operably coupled to the processor, wherein the user interface is configured to receive information about the patient-specific virtual biomechanical model from the processor and to display the patient-specific virtual biomechanical model based on the information from the processor.

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, wherein the first pad is positionable under a first foot or a prosthetic foot of the patient, and a second of the at least one force and / or pressure sensor is associated with a second pad, wherein the second pad is positionable under a second foot or a prosthetic foot of the patient.

13. A system according to claim 11, wherein the at least one motion and / or angle sensor includes five motion and / or angle sensors, wherein a first motion and / or angle sensor and a second motion and / or angle sensor are arranged on a first lower limb or a prosthesis of the patient, a third motion and / or angle sensor and a fourth motion and / or angle sensor are arranged on a second lower limb or a prosthesis of the patient, and a fifth motion and / or angle sensor is arranged on the lower back of the patient.

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, wherein the fifth motion and / or angle sensor is operably coupled to a local central processor, wherein the local central processor communicates with the processor.

15. The system of claim 11, wherein the at least one sensory stimulation unit comprises a first stimulation unit disposed on a first lower limb or a prosthesis of the patient and a second stimulation unit disposed on a second lower limb or a prosthesis of the patient, wherein each of the first stimulation unit and the second stimulation unit comprises: (a) a strap configured to be coupled to a lower limb or a prosthesis; (b) said at least two stimulators comprising four stimulators attached to said belt; and (c) one of said at least one motion and / or angle sensor associated with one of said four stimulators.

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

17. A system for improving sensory motor function in a patient, the system comprising: (a) a first foot pad unit comprising a first foot pad including at least one first force and / or pressure sensor positionable under a first lower limb of a patient or a first foot or prosthetic foot of a prosthesis; and a second foot pad unit, comprising a second foot pad, the second foot pad comprising at least one second force and / or pressure sensor positionable under a second lower limb of the patient or a second foot or prosthetic foot of the prosthesis, wherein each of the at least one first force and / or pressure sensor and the at least one second force and / or pressure sensor is configured to detect force and / or pressure information associated with the first lower limb or prosthesis and the second lower limb or prosthesis, respectively, and transmit a force and / or pressure signal based on the force and / or pressure information; (b) a first sensor processing module and a second sensor processing module, which include at least one first motion and / or angle sensor associated with the first lower limb or prosthesis of the patient; a third sensor processing module and a fourth sensor processing module, which include at least one second motion and / or angle sensor associated with the second lower limb or prosthesis of the patient; and a fifth sensor processing module comprising at least one third motion and / or angle sensor associated with the patient's lower back, wherein each of the at least one first motion and / or angle sensor, the at least one second motion and / or angle sensor, and the at least one 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 processor configured to receive the force and / or pressure signal and the motion and / or angle signal, generate a patient-specific virtual biomechanical model based on the force and / or pressure signal and the motion and / or angle signal 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; (d) at least one sensory stimulation unit, which is arranged on at least one lower limb or prosthesis of the patient, wherein The at least one sensory stimulation unit comprises at least two stimulators, the at least two stimulators being actuatable to provide stimulation to the patient based on the balanced stimulation signal; and (e) a user interface operably coupled to the processor, wherein the user interface is configured to receive information about the patient-specific virtual biomechanical model from the processor and to display the patient-specific virtual biomechanical model based on the information from the processor.

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

19. The system of claim 17, wherein the at least one sensory stimulation unit comprises: (a) a first stimulation unit, which is arranged on the first lower limb or the prosthesis of the patient, and the first stimulation unit comprises: (i) a first strap configured to be coupled to the first lower limb or prosthesis; (ii) four first stimulators attached to said first band; and (iii) one of the first sensor processing module and the second sensor processing module associated with one of the four stimulators; and (b) a second stimulation unit, which is arranged on the second lower limb or the prosthesis of the patient, the second stimulation unit comprising: (i) a second strap configured to be coupled to the second lower limb or prosthesis; (ii) four second stimulators attached to the second band; and (iii) one of the third sensor processing module and the fourth sensor processing module associated with one of the four stimulators.

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

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