Software robotic actuator and device for assisting standing and walking

Abstract

Apparatus and methods for utilizing a soft robot to facilitate standing and / or walking of pediatric patients, particularly patients suffering from dyskinesia, such as cerebral palsy. Such a soft robotic device may include a fabric pneumatic actuator that, upon inflation, generates the necessary torque along upper and lower contacts of the device to assist in movement of the patient, particularly in joint extension walking, standing, or sitting-to-standing movement. Compared with a fabric pneumatic actuator with an upright or isotropic structure, the concave structure can provide a larger torque angle and can also avoid friction and extrusion generated at the glenoid fossa. The actuator is soft, light in mass, good in compliance, and capable of providing comfortable joint extension in a multi-center trajectory. The actuator can be incorporated into a joint protector or an exoskeleton, and is very suitable for sensitive, soft and weak pediatric patients with dyskinesia, especially infants with cerebral palsy.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 544,424, filed October 16, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention generally relates to assistive robots to help pediatric patients with standing or walking motor impairments. In particular, this invention relates to the use of soft robots to assist the development of young children with motor impairments such as cerebral palsy. Background Technology

[0004] Cerebral palsy, caused by brain injury and meningitis before birth or in early infancy, is the most common motor disorder in childhood. Studies show that 3.6 out of every 1,000 infants are diagnosed with cerebral palsy. Furthermore, among children with cerebral palsy at age 8, 33.3% have limited or lost the ability to walk. Of children who have not walked by age 2, 10% can walk independently by age 6 to 7, and another 17% can walk with support. Therefore, early intervention is necessary for these children to improve prognosis. Infants and children with cerebral palsy typically exhibit a crouching gait and are unable to stand. The main reason is weakness of the extensor muscles, which cannot generate sufficient strength to maintain an upright posture under gravity. Due to the high sensitivity of the popliteal fossa (the area behind the knee joint) in infants and children, current assistive devices used to address these issues are not easily adapted to them. Soft, compliant, and lightweight contact is crucial. In addition, sufficient extension torque is required to assist standing and walking. Currently, existing soft rehabilitation robots are not well-suited for infants and toddlers under 5 years old. Summary of the Invention

[0005] Embodiments of the present invention provide a soft joint robot system for the rehabilitation of standing and walking in pediatric patients with motor disorders (such as cerebral palsy), especially infants and young children.

[0006] In one aspect, assistive soft-joint robotic devices include soft actuators having a non-stretchable fabric and a stretchable pouch actuated by inflation / deflation. In some embodiments, the actuator is a concave fabric actuator with a non-contact surface that avoids contact with the popliteal fossa (i.e., the glenoid fossa). Compared to existing motor-driven pediatric exoskeletons, the rotational and unidirectional nature of the concave fabric actuator makes it lightweight and eliminates the need for any rigid or metallic connecting mechanisms. Therefore, this design is more flexible, comfortable, and easier for young children to adapt to. The non-contact space of the concave actuator avoids friction and compression of the contact area between the actuator and the glenoid fossa. It should be noted that in some embodiments, the inner restraint layer may have some contact with the inner side of the joint, but because the central region of the soft actuator layer is concave or inclined inward when deployed to full extension, this configuration avoids applying pressure or torque along the glenoid fossa, thereby improving patient comfort. During inflation, the actuator rotates in a multi-center trajectory rather than a single axial rotation, which compliantly aligns with the movement of the joint center. In some embodiments, the maximum torque of the concave fabric actuator is less than 35 Nm, or less than 30 Nm, for example, about 26.5 Nm, which is sufficient to assist joint extension in the target population. In some embodiments, the soft joint robot is designed such that its unilateral lower limb weight is less than 0.5 kg, such as about 0.2 kg. In some embodiments, the design ensures that the low output impedance generated by deflation does not restrict the patient's movement when assistance is not required. Therefore, this design is comfortable and compliant for young children, especially infants, whose delicate, tender, and sensitive skin, arteries, and nerves are vulnerable.

[0007] Advantageously, the actuator designs described herein are highly beneficial to the following patient groups: (1) infants and young children with cerebral palsy who have limited standing and walking abilities; (2) children with cerebral palsy who have a crouching gait and limited standing and walking abilities; and (3) infants and young children with cerebral palsy who have lower limb extensor weakness. As described herein, the actuation methods presented are comfortable and compliant with the delicate, tender, and sensitive skin, arteries, and nerves of pediatric patients. While these concepts are described with reference to children, it is understood that these concepts can be extended to a wide range of other applications, particularly where patients are more sensitive or require additional flexibility and compliance.

[0008] In some embodiments, the actuator device is incorporated into an exoskeleton, while in others, it is incorporated into a joint brace worn by the patient. In one aspect, the actuator device includes a pneumatic fabric actuator that generates sufficient extension torque to begin from the standing phase. The device can be used during training to aid in the early development of the target patient. During training, the participant walks on a treadmill with a safety harness for added safety. In some embodiments, sensors such as surface electromyography (EMG) (e.g., 4-channel) can be used on each lower limb to record muscle activity during training. Furthermore, ground reaction forces can be recorded via a force plate to reflect bilateral plantar pressure and balance. These sensing parameters can be used to control the actuation of the device.

[0009] In some embodiments, the soft joint robotic device includes a soft fabric actuator that provides joint extension assistance to pediatric patients, particularly infants with cerebral palsy, to improve sitting-to-standing and squatting gait. The fabric actuator may comprise two layers of soft, flexible, lightweight material to apply compliant, comfortable joint extension, particularly suitable for the delicate, chubby lower limbs of infants. The inner layer is a stretchable pouch, and the outer, non-stretchable fabric layer restricts the expansion of the pouch. The device may be configured with an upper and lower contact surface operatively coupled to the actuator, for example, the upper and lower contact surfaces being configured to engage with the proximal limb above and the distal limb below the joint within a joint brace or exoskeleton, respectively. The actuator may be configured in a flat, isotropic, or concave shape. As used herein, "concave" refers to an actuator shape that is curved or angled inwards away from the bottom surface, such as a concave polygon or V-shape with an interior angle greater than 180 degrees as depicted herein, to avoid direct contact with the glenoid fossa. The concave actuator is particularly advantageous because it includes a non-contact surface that can be positioned along the recess of the joint. With the concave shape, as pressure increases from low to high, the combination of the inner and outer layers allows the actuator to expand and transition between three states: flat, folded, and extended. The extension torque generated by the actuator addresses the problem of excessive joint flexion in a crouching gait. Compared to upright and convex structures, the concave structure transforms a single contact surface into a contact surface on the proximal and distal limbs, and a non-contact surface above the popliteal fossa (i.e., the joint socket). Furthermore, this design rotates along a multi-center trajectory rather than a single axial rotation, compliantly aligning with the movement of the knee joint center. The non-contact space of the concave structure avoids friction and compression at the contact area between the actuator and the joint socket. When the actuator inflates, downward pressure is transferred away from the bevel of the concave design outside the joint socket. Therefore, this design is comfortable and compliant for more sensitive pediatric users, especially infants and young children.

[0010] In some implementations, soft robotic joint bracing devices are configured such that two intersecting lines between the contact and non-contact surfaces are fixed on a custom joint brace to constrain the counter-torque generated by the isotropic apex. Disconnected contact edges intersect at a virtual center. Due to the geometry of the design, the buckling angle is larger compared to designs with directly connected intersecting edges. For the same radius, the concave actuator design generates greater torque due to the increased self-intersecting region and reduced internal volume, which enhances the output torque.

[0011] Advantageously, due to the unidirectional nature of the actuator, the low output impedance generated by releasing air does not restrict the user's movement when no assistance is needed. In some implementations, based on the multi-center rotational nature, the actuator eliminates the need for connecting mechanisms or bearings, complex manufacturing processes, or high costs. Attached Figure Description

[0012] Figure 1 Side and rear views of a soft, foldable actuator device worn on a user's joints in some embodiments are shown.

[0013] Figure 2 Some embodiments of a soft, foldable actuator device worn on a user's knee joint during the standing phase are shown.

[0014] Figure 3 Some embodiments of a soft, foldable actuator worn on a user's knee during the swing phase are shown.

[0015] Figure 4 An upright pouch-type fabric actuator is shown in some embodiments.

[0016] Figure 5 Isotropic fabric actuators in some implementations are shown.

[0017] Figure 6 A concave fabric actuator is shown in some embodiments.

[0018] Figure 7 The buckling of a single-axis rotary actuator and a concave actuator in some embodiments is shown.

[0019] Figure 8 Some embodiments of soft, foldable actuators are shown, which are soft, inflatable actuators disposed between rigid restraint layers.

[0020] Figure 9 Three states of a soft, foldable actuator are shown in some implementations.

[0021] Figure 10A The flat state of a soft, foldable concave actuator is shown in some embodiments.

[0022] Figure 10B The folded state of a soft, foldable concave actuator in some embodiments is shown.

[0023] Figure 10C The fully extended state of the soft, foldable concave actuator is shown in some embodiments.

[0024] Figure 11 The deployment trajectory of a soft, foldable concave actuator in some embodiments is shown, as well as the multicentric nature of the actuator and the center of the human knee joint.

[0025] Figure 12 Finite element method (FEM) simulation analysis of soft, foldable concave actuators in some implementations is presented.

[0026] Figure 13 Torque simulations of soft, foldable concave actuators are shown in some implementations.

[0027] Figure 14 The table test results of torque and pressure of the soft, foldable concave actuator in some embodiments are shown.

[0028] Figure 15 An adjustable joint brace device with a soft, foldable concave actuator is shown in some embodiments.

[0029] Figure 16 A training system including a soft, foldable concave actuator device and a control system is shown in some embodiments.

[0030] Figure 17 A schematic diagram of the air circuit of the control system in some implementations is shown.

[0031] Figure 18 Methods for controlling the inflation and deflation of a soft, collapsible concave actuator device during gait cycles are shown in some embodiments.

[0032] Figure 19 The study demonstrates joint flexion during gait cycles in children without actuators, gait improvement in children using exemplary soft, foldable concave actuator devices, and typical children with normal gait.

[0033] Figures 20A-24D The study results demonstrate that motor function is improved through training using soft, foldable concave actuators in some implementations.

[0034] Figure 25 Examples of some implementations are shown where pediatric patients wear soft, foldable concave actuators to perform training programs.

[0035] Figure 26 Details of a soft, foldable concave actuator worn on a pediatric patient in some embodiments are shown. Detailed Implementation

[0036] This invention generally relates to assistive robotics, particularly soft robotics for assisting pediatric patients with motor disorders such as cerebral palsy, especially for improving training in walking and standing in young children.

[0037] I. System Overview

[0038] In one aspect, the present invention relates to a wearable soft robotic system comprising pneumatic actuators that provide additional force and / or torque to the limbs and / or joints of a patient with a motor impairment to further develop the relevant muscles controlling the limbs and / or joints, thereby improving the motor impairment. The soft robot, with its non-rigid components, provides the necessary force and / or torque, which is particularly useful for patients with high sensitivity, especially for pediatric patients with smaller limb proportions who are more sensitive and flexible. Pediatric patients with motor impairments (such as cerebral palsy) have deficiencies in the muscles controlling flexion and extension of joints in the distal limbs, making it difficult for these patients to achieve a standard or normal gait or to stand up from a sitting position.

[0039] In one aspect, the present invention relates to a soft robotic device or system utilizing pneumatic actuators to serve these target patients. Early childhood (e.g., under 8 years old), particularly the toddler stage (1-2 years old), is a time when the muscles controlling the lower limbs and joints are still developing, allowing these patients to greatly benefit from early intervention with assistive robots, especially in assisting joint extension during the standing and walking stages. However, conventional assistive robots, particularly those with rigid component structures, are typically designed for adolescent or adult patients and are not suitable for early childhood pediatric patients, whose limbs are disproportionately small and more flexible and sensitive. Therefore, the present invention provides a pneumatic textile exoskeleton or frame to assist pediatric patients in walking and standing, particularly for training purposes to aid muscle tissue development for long-term improvement of motor function. As an early intervention, the soft robotic device described herein aims to improve independent lower limb function in infants and young children with cerebral palsy (e.g., under 5 years old). In some embodiments, the device can be applied to training children with cerebral palsy from sitting to standing, squatting gait, and standing posture.

[0040] II. Example of a soft robot joint device

[0041] Figure 1Side and rear views of a soft, collapsible concave actuator device 100 worn on a user's knee joint are shown. As shown, the device includes a soft, collapsible concave actuator 10 worn in the user's knee socket and secured to the user via an upper connector 11 and a lower connector 12. The upper connector 11 is secured to the user's proximal limb, and the lower connector 12 is secured to the user's distal limb. The upper and lower connectors can be adjustable cuffs or adjustable straps, or any suitable means of adjustingly attaching the actuator to the user. The soft, collapsible concave actuator 10 is actuated in various configurations to apply the necessary torque to the user's joint to facilitate flexion and extension of the user's joint, providing the desired joint movement, such as walking from a seated position or standing. As shown in the left figure, the soft, foldable actuator 10 has a concave shape, that is, it bends or tilts inward at the center, avoiding the application of pressure or torque along the sensitive area of ​​the user's joint recess, thereby providing patient comfort while also supporting the necessary movement for the user's joint.

[0042] Figure 2 A soft, collapsible, concave actuator device 100 is demonstrated, worn on the user's knee joint during the swing phase. An upper connector 11 is secured to the user's proximal limb, and a lower connector 12 is secured to the user's distal limb, thereby supporting the soft, collapsible actuator 10 behind the user's joint. When the user's foot initially contacts the ground, the actuator 10 begins to inflate to extend the flexed knee joint. As shown, the fully extended actuator provides joint support from initial contact to mid-standing posture. When full extension is reached, a restraining layer limits the angle of this posture due to its geometry. This ensures strong support for joint extension while preventing overextension. For target groups with cerebral palsy, the actuator can be customized to individual needs to ensure safety and comfort. As shown, the concave design of the actuator's central portion substantially avoids contact with the hollow of the user's joint during the standing phase.

[0043] Figure 3A soft, collapsible, concave actuator device 100 is demonstrated, worn on the user's knee joint during the standing phase. As the actuator begins to release pressurized air, the restraining layer accelerates deflation. Therefore, the actuator's higher repeatability promotes stability during use. Furthermore, due to the high flexibility of the soft actuator, it does not generate additional extension torque, causing the restraining layer to immediately flatten the actuator. Thus, during the swing phase of the gait cycle, the actuator does not impede the user's joint flexion. As shown, the concave design of the actuator's central portion substantially avoids applying pressure along the user's joint depression during the flexion phase. Therefore, the actuator's concave design provides the necessary torque and support to the user's joint for the required movement while substantially avoiding applying pressure or torque to the user's joint depression, thereby improving patient comfort.

[0044] Figures 4-7 Different types of fabric actuators are demonstrated, specifically upright pouch-type fabric actuators, isotropic fabric actuators, and concave fabric actuators. It is understood that these actuator designs are exemplary, and variations of these designs remain within the scope of the inventive concepts described herein.

[0045] Figure 4 An upright pouch-type fabric actuator 200 is shown. In this embodiment, during inflation, the actuator disengages from the patient's knee joint. The rotation of the upright actuator is a single-axis rotation.

[0046] Figure 5 An isotropic fabric actuator 300 is shown. In this embodiment, the isotropic structure disengages during inflation. The rotation of the isotropic actuator is a single-axis rotation.

[0047] Figure 6 A concave fabric actuator 400 is shown. The concave structure is formed on the bottom surface that rests against the patient's leg, creating a non-contact surface between the contact surfaces. An advantage of this embodiment is that the non-contact surface can be positioned behind the joint in a soft joint device using this actuator, thus avoiding contact and friction behind the joint. This design also provides greater torque due to its geometry, as detailed below.

[0048] Figure 7 The buckling behavior of a single-axis rotary actuator and a concave actuator 400' is illustrated. As shown, compared to the upright actuator and the isotropic actuator, the concave actuator 400' produces a larger buckling angle for the same diameter. It is understood that, as described herein, such an actuator can be introduced into soft fabric actuators.

[0049] Figure 8An exemplary soft, foldable, concave actuator 10 is shown, comprising a rigid restraint layer (inner layer 5 and outer layers 6, 7) and a soft actuator 4 located in the middle of the rigid restraint layer. The soft actuator includes two foldable structural units 1 that extend inward from the middle portion of the inner layer 5 to form a concave shape. When air is supplied to the actuator, each foldable structural unit 1 extends like a spring, generating torque between the upper and lower parts of the device attached to the proximal and distal limbs, while no compression is generated in region 2 within the concave area along the sensitive articular socket. Typically, the restraint layer is made of a material with higher stiffness than the foldable actuator. The higher stiffness of the foldable structure maintains structural integrity and stability even when folded, ensuring stable performance during deployment. As shown, two rigid restraint layers can be integrated at the apex of each foldable actuator unit.

[0050] Figure 9 The diagram illustrates three states (I, II, III) of the soft, collapsible concave actuator 10, generated by pressurized fluid entering and exiting the actuator as shown by the axis at the bottom. In the left diagram, the actuator is in a flat state (I) without any pressurized fluid applied. In the middle, the actuator expands into a folded state (II) when pressurized fluid is introduced. In the right diagram, the actuator is in a fully extended state (III) as pressurized fluid continues to be introduced.

[0051] Figure 10A The flattened state of the soft, foldable concave actuator 10 is shown. When there is no pressurized air input or the actuator begins to deflate, the more rigid confinement layers (5, 6, 7) flatten and tighten the central soft actuator 4, forming the pre-deformed initial flattened shape. Due to the actuator's good flexibility when releasing air, the more rigid confinement helps to improve the response rate and repeatability during deformation.

[0052] Figure 10B The soft, foldable concave actuator 10 is shown in its folded state, i.e., its pressurized state. As pressurized air begins to be transmitted to the actuator 4, an extension torque is generated between the upper and lower parts as the folded structure unfolds along the crease in the middle of each section and expands the limiting layers (5, 6, 7). Throughout inflation, the central region of the actuator tilts inward away from the glenoid fossa, thus preventing compression of the sensitive glenoid fossa, which is filled with nerves and blood vessels.

[0053] Figure 10C The fully extended state of the soft, foldable concave actuator 10 is shown. The actuator fully extends the knee joint when the extension torque is greater than the sum of the flexion torques of the squatting knee joint and the limiting layers (5, 6, 7). The geometry of the limiting layers restricts the angle of the extension configuration.

[0054] In another respect, compared to joint braces with a single center of rotation, the soft, collapsible concave actuator configured herein is multi-centered, more closely resembling the multi-centered flexion of a natural knee joint. (See reference...) Figure 11 This aspect can be further understood. Figure 11 The leftmost figure shows the deployment trajectory of the soft, foldable concave actuator 10 from a flat state (no pressurized air input) to a fully extended state (filled with pressurized air input). The center figure shows the different centers of rotation c of the actuator during the deployment trajectory. The right figure illustrates the multi-center movement of the human joint. Therefore, the multi-center movement of the soft, foldable concave actuator closely approximates the movement of the center of the human knee joint, providing improved movement that more closely resembles a normal gait, thus enabling better training and improving user comfort. Due to the combination of the more rigid folding restraint layer and the soft actuator, asymmetric deployment achieves alignment of the multi-center movement of the knee joint, ensuring user compliance and comfort.

[0055] Figure 12 A finite element method (FEM) simulation analysis of a soft, foldable concave actuator 10 is presented. In this simulation, the actuator is modeled in three dimensions as a shell type. The material density is set to 1.14 x 10⁻⁶. -9 g / m 3 The actuator has a thickness of 0.8 mm, a Young's modulus of 395 MPa, and a Poisson's ratio of 0.23. The burst pressure of the actuator is 160 kPa. As shown in the figure, the stress is mainly concentrated on the fold creases and edges. This simulation demonstrates how controlled deployment of the actuator can be achieved by controlling the pressurization of the air entering and exiting the actuator to generate the required angle and torque, thereby providing the desired joint movement.

[0056] Figure 13 The torque simulation of the soft, foldable concave actuator 10 is shown when the maximum input air pressure is 140 kPa. In this embodiment, the maximum extension torque is 32 Nm. Within a pressure range of 30 kPa to 70 kPa, the torque remains stable between 6 Nm and 10 Nm during both inflation and deflation, which is a safe pressure for practical use.

[0057] Figure 14 The results of torque versus pressure tests on a worktable were presented for soft, foldable concave actuators 10 with radii of 12.5 mm, 25 mm, and 30 mm. Target extension torques of 6 Nm to 15 Nm were generated under pressures ranging from 20 kPa to 60 kPa. These torques are ideal for assisting joint movements in young children, especially infants.

[0058] Figure 15An adjustable joint brace device 100 utilizing a soft, foldable concave actuator 10 is demonstrated. In this embodiment, the soft, foldable concave actuator 10 is sewn onto a joint brace having an upper connection 11 and a lower connection 12 to transmit extension torque to the knee joint. The device is configured such that the concave or inwardly extending portion of the actuator is positioned along the joint socket to avoid compression and friction along the joint socket. In this embodiment, the upper connection 11 and lower connection 12 are defined by adjustable nylon fastening bands 16, configured for releasable connection to the patient's proximal and distal limbs, respectively. It is understood that various other types of fasteners or cuffs may also be used. In some embodiments, one or more sensors may be used. In this embodiment, two inertial measurement units (IMUs) 17 and 18 are mounted on the nylon fastening bands of the proximal and distal limbs to collect kinematic information of the knee joint. This information can be fed back to controls to improve joint movement during use.

[0059] Figure 16 The training system components are shown, including a joint brace device 100 (with a soft, foldable concave actuator 10) and a control system 500. The control system 500 includes a controller 24 connected to a computer 23, which sends commands to switch the air compressor 25 on and off. The air compressor 25 is connected to the actuator 10 via a pressurized air line 20. In some embodiments, one or more sensors may be included on the user's foot. In this embodiment, force-sensitive resistors (FSRs) 22 on the front and back of the user's foot are used to trigger the inflation of the actuator 10. Additionally, IMU sensors 17 and 18 may be mounted on the proximal and distal limbs of the knee joint. In some embodiments, the control system includes a microcontroller unit that uses knee joint angle signals, pressure signals, ground contact sensing signals, muscle activity signals, or any combination thereof as input.

[0060] Figure 17 The air circuit 600 of the control system is shown. A pressure source 601 outputs compressed air to a check valve 602 to limit the pressure range applied to the actuator 10. Pressure within the safe range is supplied to a pressure regulator 603, which outputs a preset pressure to the actuator 10 to inflate it, thereby generating the required torque.

[0061] Figure 18 A method for controlling the inflation and deflation of a soft, collapsible concave actuator 10 during a gait cycle is demonstrated. In the initial contact state, when the FSR value is greater than a threshold, the actuator inflates to assist joint extension during the standing phase. When the FSR value is less than the threshold, the inflated actuator deflates during the swing phase until the next gait cycle. Figure 19The study demonstrates joint flexion during gait cycles in children without actuators, joint flexion during improved gait in children using an exemplary soft foldable concave actuator device, and joint flexion in typical children with normal gait.

[0062] III. Research and Survey Data

[0063] To validate the effectiveness of the soft-jointed robot, a pilot clinical trial was conducted on five local participants aged 2 to 12 years. Each participant received 20 training sessions, twice a week, each session consisting of 40 minutes of gait training. During each gait cycle of training, the actuators inflated when plantar pressure exceeded a threshold. Triggering progress was entirely based on the participant's subjective intention. Based on pre- and post-assessments, all five participants showed improvements in crouching gait, motor function, walking speed, walking endurance, muscle tone, balance scale, and duration from sit to stand. Detailed measurements demonstrating these improvements are available in [link to relevant documentation]. Figures 20A-24D .

[0064] Figures 20A-20C This demonstrates the improvement in motor function achieved by training five subjects using the soft joint robot device described in this paper. Figure 20A (GMFC88D) describes the standing motor function assessment scores of five subjects before and after training. The results indicate that the improvement in standing motor function is statistically significant (P = 0.0378). Figure 20B (GMFC88E) describes the walking, jumping, and running motor function assessment scores of five subjects before and after training. The results indicate a high statistical significance for the improvements in walking, jumping, and running motor function (P = 0.0039). Figure 20C The total scores of five subjects before and after GMFC88D and GMFC88E were plotted. The results indicate a high statistical significance of improvement (P = 0.0025).

[0065] Figure 21 The scores of the balance scale assessment of five subjects before and after training were depicted. The results indicate a high statistical significance for the improvement in balance (P = 0.0054).

[0066] Figures 22A-23 This demonstrates the improvement in walking speed and walking endurance achieved by training five subjects using the soft articulated robotic device described in this paper. Figure 22A The self-selected speed of the five subjects in the 10-meter walking test before and after training was described. The results showed a high statistical significance of improvement (P = 0.0044). Figure 22B The rapid walking speed of five subjects in a 10-meter distance was described before and after training. The results indicate statistical significance of the improvement (P = 0.0266). Figure 23 The walking endurance of five subjects before and after training was assessed in a 6-minute walking test. The results showed a high statistical significance for improvement (P = 0.0039).

[0067] Figures 24A-24D This study demonstrates the improvement in muscle tone achieved by training five subjects using the soft-joint robotic device described herein. Figure 24A The study described the muscle tone assessment of the joint extensors in the more severely affected limbs of five subjects before and after training. The results indicated statistical significance of improvement (P = 0.0213). Figure 24B The study described the muscle tone assessment before and after training for the total scores of the hip, knee, and ankle joints in the more severely affected limbs of five subjects. The results showed a high statistical significance for improvement (P = 0.0081). Figure 24C The study described the assessment of muscle tone in the extensor muscles of five subjects before and after training in limbs with minor impairments. The results indicated statistically significant improvement (P = 0.0217). Figure 24D The study described the changes in muscle tone before and after training in the total scores of the hip, knee, and ankle joints of five subjects with less impairment. No statistically significant improvement was observed.

[0068] Figure 25 An example of a training session is shown where a pediatric patient (PP) wearing a soft, foldable, concave actuator device 100 walks on a treadmill using a supportive aid (e.g., a suspension strap). The soft-joint robotic support includes the soft, foldable actuator described herein. Figure 26 Closer details of a soft, foldable concave actuator worn on a pediatric patient in some implementations are shown.

[0069] In the foregoing specification, the invention has been described with reference to specific embodiments thereof, but those skilled in the art will recognize that the invention is not limited thereto. Various features, embodiments, and aspects of the invention described above can be used individually or in combination. Furthermore, the invention can be used in any other environment and application beyond those described herein without departing from the broader spirit and scope of the specification. Therefore, the specification and drawings should be considered illustrative rather than restrictive. It will be appreciated that the terms “comprising,” “including,” and “having” as used herein should be specifically understood as open-ended technical terms. For all purposes, the entire contents of any publications, patents, or patent applications referenced herein are incorporated herein by reference.

Claims

1. A control device for wearing in the joint recess of a user, comprising: A foldable actuator configured to be placed along the user's joint recess; The foldable actuator includes a soft actuator layer disposed between restraining layers, the restraining layers being configured to prevent overcorrection during movement, and a central region on one side of the actuator layer being concave or inclined inward when unfolded, extending away from the articular socket; and The actuator is designed to generate torque sufficient to extend the user's joints when pressure is applied to the folding structure.

2. The apparatus according to claim 1, wherein, The upper and lower parts of the device are connected by the foldable actuator, which is configured to allow the user's joints to be fully flexed while maintaining support, and to suppress pressure on the depressions of the joints for patient comfort.

3. The apparatus according to claim 1, wherein, The foldable actuator includes multiple folding structures.

4. The apparatus according to claim 1, wherein, The actuator is configured to be actuated by supplying or venting pressurized fluid into or out of the actuator, thereby arranging the actuator in three states: a flat state, a pleated state, and a fully extended state.

5. The apparatus according to claim 4, wherein, When air is released during the swing phase of the user's gait, or to facilitate the user's bending of the joints while seated, the stiffness of one or more of the limiting layers flattens the soft actuator to the pre-deformed initial shape of the flattened state.

6. The apparatus according to claim 4, wherein, The actuator, which unfolds from the flat state to the fully extended state, has an asymmetrical and multi-center unfolding mode, thereby improving the consistency with the multi-center movement of the user's joint centers.

7. The apparatus according to claim 6, wherein, The asymmetric and multi-center deployment method is provided by the combination of the folded rigid constraint layer and the soft actuator layer.

8. The apparatus according to claim 1, wherein, The intermediate region is located at the junction of the folds in the soft actuator layer to avoid engagement with the articular socket during actuation.

9. The apparatus according to claim 1, wherein, Each of the limiting layers consists of multiple folded structures.

10. The apparatus according to claim 1, wherein, The foldable actuator comprises two layers: an outer layer comprising a non-stretchable material and an inner layer comprising a expandable sac. The outer layer defines the restraint layer, and the inner layer defines the soft actuator layer.

11. The apparatus according to claim 1, further comprising: Adjustable joint brace with the aforementioned foldable actuator.

12. The apparatus according to claim 11, wherein, The adjustable joint brace is configured to connect to the proximal and distal limbs surrounding the user's joint.

13. The apparatus of claim 11, further comprising: Motion measurement sensors and ground contact detection sensors.

14. The apparatus of claim 11, further comprising: A pressure regulator is used to control the pressure transmitted to the soft actuator layer.

15. The apparatus of claim 11, further comprising: The control unit utilizes: joint angle signals, pressure signals, ground contact response signals, muscle activity signals, or any combination thereof as input.

16. The apparatus of claim 11, further comprising: A graphical user interface for user interaction.

17. A soft robot actuator, comprising: A non-stretchable fabric portion is configured to engage with the patient along the contact surface; as well as A stretchable pouch portion is at least partially attached to the non-stretchable fabric portion, wherein the stretchable pouch portion stretches to different states when different pressures are applied to the pouch portion, thereby generating the required torque to assist the patient's joint movement.

18. The soft robot actuator according to claim 17, wherein, The actuator is equipped with a controller that, in response to a motion phase sensor, controls the application of pressure to control the expansion of the pouch to different phases corresponding to the sensed motion phases.

19. The soft robot actuator according to claim 17, wherein, The different phases include joint extension during the movement from sitting to standing.

20. The soft robot actuator according to claim 17, wherein, The different phases include joint extension during walking movement to improve crouching gait.

21. The soft robot actuator according to claim 17, wherein, The actuator is configured to be worn by children aged five or under with motor impairments.

22. The soft robot actuator according to claim 17, wherein, The actuator has a concave shape that defines a non-contact area positioned along the joint socket.

23. The soft robot actuator according to claim 22, wherein, The actuator comprises at least two layers: the first layer is a fabric of soft, flexible, and lightweight material that provides compliant and comfortable joint extension for the patient; the second layer comprises a stretchable pouch.

24. The soft robot actuator according to claim 22, wherein, The actuator is configured to be worn by children aged five or under with motor impairments.

25. The soft robot actuator according to claim 22, wherein, The actuator is configured such that the non-stretchable fabric is configured as an outer layer that restricts the expansion of the pouch portion.

26. The soft robot actuator according to claim 22, wherein, The actuator is configured such that when the pressure increases from low pressure to high pressure, the combination of the inner and outer layers causes the actuator to expand and transition between at least three states: a flat state, a wrinkled state, and an extended state.

27. The soft robot actuator according to claim 25, wherein, The actuator is configured such that when worn by the patient, the extended state generates an extension torque on the patient's joint, wherein the extension torque is sufficient to resolve the problem of excessive joint flexion in a squatting gait.

28. The soft robot actuator according to claim 22, wherein, The actuator is configured in any of the following shapes: upright, isotropic, and concave.

29. The soft robot actuator according to claim 22, wherein, The actuator is configured in a concave shape, which transforms the contact surface into a contact surface on the patient's proximal and distal limbs and a non-contact surface along the patient's glenoid cavity to avoid friction and compression of the glenoid cavity.

30. The soft robot actuator according to claim 22, wherein, The actuator is configured such that when the actuator, worn by the patient while standing, is inflated, the downward pressure applied by the actuator is transferred from the inclined side between the upper and lower contact areas out of the glenoid region.

31. A joint brace, comprising: The upper and lower connecting portions are configured for adjustable connection with the patient's proximal and distal limbs; as well as A soft robotic actuator is connected to the upper connecting part and the lower connecting part.

32. The joint brace according to claim 31, wherein, The actuator has a concave design and is configured to rotate in a multi-center trajectory rather than a single axis, in order to compliantly synchronize with the movement of the center of the knee joint.

33. The joint brace according to claim 31, wherein, The actuator extends along an upper contact surface and a lower contact surface, with a non-contact surface between the upper contact surface and the lower contact surface, wherein the non-contact surface is positioned along the glenoid fossa when worn by the patient.

34. The joint brace according to claim 31, wherein, The concave actuator is configured such that the generated output torque is enhanced by reducing the internal volume associated with the concave surface design.

35. The joint brace according to claim 31, wherein, The actuator is unidirectional, and when no assistance is needed, the low output impedance generated by releasing pressurized air does not restrict the patient's movement.

36. The joint brace according to claim 31, wherein, The actuator has no connecting mechanism or bearings.

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