Hand rehabilitation orthosis and dynamic spasm monitoring method thereof

Abstract

The invention provides a hand rehabilitation orthosis and a dynamic spasm monitoring method thereof. The hand rehabilitation orthosis comprises an orthosis mechanism worn on the hand of a patient and a driving mechanism worn on the arm of the patient and used for driving the orthosis mechanism. The orthopedic mechanism comprises a palm part supporting piece located at the palm center of a patient, a thumb orthopedic assembly movably connected with the palm part supporting piece and a four-finger orthopedic assembly movably connected with the palm part supporting piece. The driving mechanism comprises a plurality of miniature electric push rods used for driving the thumb orthopedic assembly and the four-finger orthopedic assembly. Compared with the prior art, the hand rehabilitation orthosis has the advantages that the technical scheme of structural design, motion sensing design, driving design and the like of the hand rehabilitation orthosis is innovated by building a spasm grade dynamic prediction model, and the hand rehabilitation orthosis which can achieve dynamic spasm monitoring, has high adaptability and effectively assists patient rehabilitation is developed. And a better treatment scheme is provided for hand spasm rehabilitation of stroke patients.

Description

Technical Field

[0001] The present invention relates to the technical field of hand rehabilitation orthosis, and in particular to a hand rehabilitation orthosis and a dynamic spasm monitoring method thereof. Background Art

[0002] Hand spasticity after stroke is a common symptom of abnormal nervous system function, caused by pathological damage to the upper motor neurons, resulting in imbalanced muscle tension and involuntary flexion of the wrist and fingers, which greatly limits the patient's ability to live in daily life. If not effectively treated, patients may experience muscle atrophy, joint contracture deformity, and even develop irreversible disability. Globally, stroke is an important cause of death and disability, and China has the highest prevalence of stroke in the world. Hand spasticity, as a common complication of stroke, places a heavy burden on patients' quality of life and medical resources.

[0003] At present, the main treatments for hand spasticity include manual therapy, drug therapy, surgical treatment and orthosis-assisted treatment. Although manual therapy is effective and can relieve pain and improve upper limb function, it cannot meet the patient's needs for continuous treatment due to insufficient professionals, and its mechanism of action is unclear, and the correlation between the treatment effect and movement remains to be studied. Drug therapy can only temporarily inhibit or relax spastic muscles, and has limited help in functional recovery. Long-term use may also cause dependence and side effects. Surgical treatment is often used for patients with severe spasticity or joint deformities. It has high risks and long recovery time, and is usually the last choice after other treatments are ineffective. In this treatment context, hand rehabilitation orthosis has become an important auxiliary treatment method. It aims to provide passive, active and active auxiliary rehabilitation treatment for the hand, which alleviates the problem of shortage of professional and technical personnel resources to a certain extent. However, the application requirements of hand rehabilitation orthosis are highly individualized and dynamically changing. Existing orthosis has many deficiencies in design and function, which are difficult to meet the actual clinical needs. The specific deficiencies are as follows:

[0004] First, existing hand spasticity rehabilitation orthoses lack the ability to monitor dynamic spasticity. Currently, most rehabilitation orthoses adopt a static treatment strategy and cannot perceive the dynamic changes in the patient's spasticity level during treatment in real time. In clinical treatment, the patient's spasticity state will change over time, and existing orthoses cannot adjust the treatment plan based on these changes, making it difficult to meet the patient's personalized needs, resulting in poor rehabilitation results. For example, during manual therapy, the patient's spasticity level gradually decreases, but the treatment intensity of the fixed orthosis cannot change accordingly, affecting the rehabilitation process.

[0005] Second, existing methods for assessing hand spasticity are inaccurate and incomplete. Traditional spasticity assessment tools, such as the Ashworth scale and modified Ashworth scale commonly used in clinical practice, are highly dependent on the subjective experience of doctors, have vague scoring criteria, poor consistency between assessors, and are difficult to reflect changes in the patient's spasticity level in real time. Although instrument measurement methods are relatively objective, they have problems such as cumbersome operation, the need for professional equipment and personnel, and complex data processing. Moreover, existing assessment methods often only focus on single-dimensional characteristic parameters and are unable to fully grasp the complex pathophysiological characteristics of spasticity, resulting in the inability of the assessment results to accurately reflect the patient's actual spasticity condition, affecting the formulation and adjustment of rehabilitation treatment plans.

[0006] Third, the structural design of existing hand spasticity rehabilitation orthoses is unreasonable. Existing hand spasticity rehabilitation orthoses are mainly divided into fixed orthoses and dynamic orthoses. Although existing fixed orthoses can provide basic rehabilitation support, they have many limitations. For example, its fixed treatment intensity is difficult to adapt to the dynamic changes in the patient's spasticity level. Long-term wearing may cause local compression discomfort or pain, and the lack of active movement stimulation affects the patient's motor function recovery. The rigid connecting rod structure of the dynamic orthosis increases the volume, weight and complexity of the wearable part of the orthosis, which may cause discomfort to the human joints; although the flexible structure improves comfort, there are challenges in force transmission efficiency and precise control. At the same time, the existing orthoses also have shortcomings in the wearing method. For example, some designs are not conducive to wearing by patients with hand spasticity, which affects the patient's usage experience and rehabilitation enthusiasm.

[0007] Fourth, the existing drive systems of hand spasticity rehabilitation orthoses have defects. Existing drive schemes for powered orthoses have their own drawbacks. The drive designs include pneumatic / hydraulic, motor and cable drive. Pneumatic / hydraulic drive has problems such as complex actuator model, difficult control, low degree of freedom, and large size; motor drive requires a complex mechanical structure, which increases the size and weight of the system and affects portability; although cable drive has a simple structure and light weight, it has problems such as difficulty in embedding sensors, grasping movement is mainly achieved through under-actuation, and may cause pain and discomfort to patients. These defects limit the function and clinical application of orthoses, making it impossible to provide patients with efficient and comfortable rehabilitation training.

[0008] Fifth, existing rehabilitation orthoses for hand spasticity are out of touch with clinical needs. The rehabilitation orthoses currently on the market are difficult to effectively reproduce the clinical effects of manual therapy and cannot meet the needs of multiple stakeholders. Therapists expect orthoses to simulate manual therapy movements more comprehensively and cover more rehabilitation functions to reduce work pressure; patients hope that orthoses are easy to operate, effective, comfortable to wear and economical; family members hope that orthoses can efficiently assist patients in rehabilitation and reduce the burden on the family. However, existing orthoses have shortcomings in these aspects and there is a large gap with actual clinical needs. Summary of the invention

[0009] In view of the shortcomings of the prior art mentioned above, the object of the present invention is to provide a hand rehabilitation orthosis and a dynamic spasm monitoring method thereof, so as to solve the problems existing in the clinical application of the existing hand spasticity rehabilitation orthosis in patients with hand spasticity after stroke, such as untimely spasticity monitoring, inaccurate evaluation, poor structural design, drive system defects and disconnection with clinical needs.

[0010] In order to achieve the above-mentioned purpose and other related purposes, the present invention provides the following technical solutions:

[0011] A hand rehabilitation orthosis comprises an orthotic mechanism worn on a patient's hand and a driving mechanism worn on the patient's arm and used to drive the orthotic mechanism; wherein the orthotic mechanism comprises a palm support located at the center of the patient's palm, a thumb orthotic assembly movably connected to the palm support and worn on the thumb, and a four-finger orthotic assembly movably connected to the palm support and worn on the remaining four fingers; the driving mechanism comprises a plurality of micro electric push rods for driving the thumb orthotic assembly and the four-finger orthotic assembly, wherein the plurality of micro electric push rods are movably connected to the thumb orthotic assembly and the four-finger orthotic assembly respectively through a thumb driving connecting rod and a four-finger driving connecting rod, and an arm ring for wearing on the patient's arm is installed at the end of the micro electric push rod away from the driving connecting rod.

[0012] In one embodiment of the present invention, the thumb orthosis assembly includes a first thumb cuff, a second thumb cuff movably connected to the first thumb cuff, and a thumb support connected to the palm support; the first thumb cuff is also movably connected to the second thumb cuff via a first cuff connecting rod assembly; the second thumb cuff is movably connected to the thumb support via a first thumb support connecting rod assembly; and the thumb support is also slidably connected to the thumb drive connecting rod.

[0013] In one embodiment of the present invention, the first thumb sleeve connecting rod assembly includes a first thumb sleeve connecting rod movably connected to the first thumb sleeve and a second thumb sleeve connecting rod movably connected to the first thumb sleeve connecting rod, the second thumb sleeve connecting rod is also movably connected to the second thumb sleeve, and the movable connection between the first thumb sleeve connecting rod and the second thumb sleeve connecting rod is movably connected to the thumb drive connecting rod.

[0014] In one embodiment of the present invention, the first thumb support link assembly is divided into two groups, each group of the first thumb support link assembly includes a first thumb support link movably connected to the second thumb finger sleeve and a second thumb support link movably connected to the first thumb support link, and the second thumb support link is also movably connected to the thumb part support.

[0015] In one embodiment of the present invention, the four-finger orthotic assembly includes a first four-finger cuff, a second four-finger cuff movably connected to the first four-finger cuff, and a third four-finger cuff movably connected to the second four-finger cuff; the first four-finger cuff, the second four-finger cuff and the third four-finger cuff are also movably connected via a second cuff connecting rod assembly; the third four-finger cuff is movably connected to the palm support member via a first four-finger support connecting rod assembly.

[0016] In one embodiment of the present invention, the first finger sleeve link and the second finger sleeve link both adopt a planar double four-bar linkage, and the second finger sleeve link assembly includes a first four-finger sleeve link movably connected to the first four-finger sleeve, a second four-finger sleeve link movably connected to the first four-finger sleeve link, a third four-finger sleeve link movably connected to the first four-finger sleeve link and the second four-finger sleeve link respectively, and a fourth four-finger sleeve link movably connected to the third four-finger sleeve link; the second four-finger sleeve link is also movably connected to the second four-finger sleeve, the fourth four-finger sleeve link is also movably connected to the third four-finger sleeve, and the movable connection between the third four-finger sleeve link and the fourth four-finger sleeve link is movably connected to the four-finger drive link.

[0017] In one embodiment of the present invention, the first four-finger support member link assembly is also divided into two groups, and each group of the first four-finger support member link assembly includes a first four-finger support member link movably connected to the third four-finger finger sleeve and a second four-finger support member link movably connected to the first four-finger support member link, and the second four-finger support member link is also movably connected to the palm support member.

[0018] In one embodiment of the present invention, the first thumb sleeve, the second thumb sleeve, the first four-finger sleeve, the second four-finger sleeve and the third four-finger sleeve all include a first finger sleeve contacting the pulps of the patient's fingers and a second finger sleeve contacting the backs of the patient's fingers, and the first finger sleeve and the second finger sleeve are connected by a snap assembly; a force tactile sensing unit is installed on the side of the first finger sleeve opposite to the second finger sleeve through a finger pulp covering structure, and the sensing contacts of the force tactile sensing unit pass through the first finger sleeve and contact the pulps of the patient's fingers; the side of the second finger sleeve opposite to the first finger sleeve is connected to two mounting plates integrally formed with the second finger sleeve, and a placement groove for installing an IMU sensor is formed between the two mounting plates and the second finger sleeve.

[0019] A dynamic spasm monitoring method based on the hand rehabilitation orthosis, the method comprising the following steps: obtaining force tactile pressure data and inertial measurement data of a patient who is receiving treatment with a hand rehabilitation orthosis, collected by a force tactile sensing unit and an IMU sensor, wherein the force tactile pressure data and inertial measurement data are integrated by a closed-loop drive control method based on multimodal data fusion; inputting the force tactile pressure data and inertial measurement data into a spasm level prediction model, obtaining the patient's spasm level through the spasm level prediction model, obtaining a pre-set treatment strategy corresponding to the spasm level, and using the force tactile pressure data and inertial measurement data in the treatment strategy as a rehabilitation training reference trajectory, and regulating the hand rehabilitation orthosis to perform rehabilitation movements through a multi-level control architecture.

[0020] In one embodiment of the present invention, before acquiring the force tactile pressure data and inertial measurement data of the patient who is treated with a hand rehabilitation orthosis collected by the force tactile sensing unit and the IMU sensor, it also includes: using an integrated sensor including a surface electromyography sensor and an IMU sensor to collect the surface electromyography signal and inertial measurement data of the patient during each treatment, and at the same time, the doctor uses a spasm level assessment method to score the spasm level of the patient for each treatment; acquiring the force tactile pressure data and inertial measurement data and using them as input, acquiring the spasm level score rated by the doctor and using them as output, using the force tactile pressure data, inertial measurement data and spasm level score to train an initial spasm level prediction model, and obtaining the spasm level prediction model according to the training results;

[0021] Among them, before the force tactile pressure data and inertial measurement data are input into the initial spasm level prediction model, it also includes: first reducing the noise of the force tactile pressure data and inertial measurement data; then using a dual-threshold based detection method to extract the action interval and manually verify it; then extracting the time domain feature value, the time domain feature value includes but is not limited to RMS, MAV, iEMG and A-ApA and other electromyographic signal characteristics.

[0022] As described above, the hand rehabilitation orthosis and the dynamic spasm monitoring method thereof of the present invention have the following beneficial effects:

[0023] 1. In terms of spasm monitoring, the present invention innovatively realizes continuous monitoring of spasm levels during manual therapy through real-time acquisition of surface electromyographic signals and construction of a spasm level prediction model. Not only is the spasm level assessment method introduced to improve the assessment precision, but the correlation between various surface electromyographic signal characteristics and spasm levels is also analyzed. Compared with the spasm assessment methods in the prior art that rely on subjective scale assessments or only focus on single-dimensional feature parameters, the present invention can more accurately and comprehensively grasp the spasm state and its dynamic changes, providing a more scientific basis for rehabilitation treatment.

[0024] 2. In terms of the structural design of the orthosis, the present invention adopts an open-type wearing structure on the back of the hand, integrates a special buckle to fix the IMU sensor, designs a fingertip covering structure to fix the force tactile sensing unit, places the main body in the palm area, and uses a four-bar linkage to control the distal interphalangeal joints, releasing a certain degree of freedom at the metacarpophalangeal joints. This design improves the convenience of wearing, ensures the accuracy of data collection, avoids finger interference, and enhances the freedom of movement and wearing comfort. Compared with existing orthoses, existing fixed orthoses have problems such as difficulty in adapting the treatment intensity to changes in spasms, a sense of oppression when worn for a long time, and a lack of active movement stimulation; the rigid structure of the dynamic orthosis is large in size, and the flexible structure is difficult to transmit and control force. The orthosis structure of the present invention has obvious advantages in terms of function, practicality and comfort.

[0025] 3. In terms of motion sensing design, the present invention constructs a hand motion posture capture system based on IMU sensors and force tactile sensing units. In terms of hardware, suitable sensors are selected and arranged reasonably, the finger ring and fingertip covering structure are designed to be fixed, the power supply circuit and data acquisition program are designed using the main control board to achieve stable power supply and efficient acquisition of sensor data, and a special PCB board is designed to optimize the layout; the Kalman filter algorithm is used to process data in software to achieve high-precision data acquisition and processing. Compared with the problems that may exist in the prior art in terms of hand motion capture, such as unreasonable sensor layout, low data acquisition accuracy, simple processing methods, etc., the present invention can more accurately record the hand motion trajectory of patients during rehabilitation treatment, and provide more reliable data support for orthosis drive design.

[0026] 4. In terms of drive design, the orthosis drive mechanism of the present invention refers to the passive orthosis, uses a planar four-bar linkage to drive the interphalangeal joints, releases the degrees of freedom at the metacarpophalangeal joints, and adopts an under-driven solution with a single driving force source for each finger. The drive motor uses a micro electric push rod and is equipped with a special arm ring fixing structure. In terms of control, a closed-loop drive control solution based on multimodal data fusion is adopted to integrate surface electromyography signals and inertial measurement data to construct a dual closed-loop feedback mechanism. Compared with the existing drive solutions of dynamic orthoses, such as pneumatic / hydraulic drives, which have complex models, difficult control, low degrees of freedom, large size, complex motor drive structures that affect portability, and cable drive sensors that are difficult to embed and easily cause pain and discomfort to patients, the drive design of the present invention has obvious advantages. While ensuring the accuracy of motion control, it reduces the complexity and cost of the system, improves the intelligence level and safety of rehabilitation training, and can better meet the rehabilitation needs of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a left frontal stereoscopic schematic diagram of a hand rehabilitation orthosis in a first embodiment of the present invention;

[0028] Figure 2is a front view schematic diagram of a hand rehabilitation orthosis in a first embodiment of the present invention;

[0029] Figure 3 is a rear view schematic diagram of a hand rehabilitation orthosis in a first embodiment of the present invention;

[0030] Figure 4 It is a three-dimensional schematic diagram of a thumb orthosis component, a four-finger orthosis component and a driving connecting rod in a hand rehabilitation orthosis in a first embodiment of the present invention;

[0031] Figure 5 It is a three-dimensional schematic diagram of the arm ring of the hand rehabilitation orthosis in the first embodiment of the present invention;

[0032] Figure 6 is a schematic diagram of an underactuated solution in a hand rehabilitation orthosis in a first embodiment of the present invention;

[0033] Figure 7 It is a left frontal stereoscopic schematic diagram of a thumb orthosis component and a four-finger orthosis component in a hand rehabilitation orthosis according to a first embodiment of the present invention;

[0034] Figure 8 It is a left-side stereoscopic schematic diagram of a thumb orthosis component and a four-finger orthosis component in a hand rehabilitation orthosis according to a first embodiment of the present invention;

[0035] Fig. 9 is a three-dimensional schematic diagram of a thumb orthosis component in a hand rehabilitation orthosis according to a first embodiment of the present invention;

[0036] Fig.10 It is a three-dimensional schematic diagram of a four-finger orthosis component and a palm support component in a hand rehabilitation orthosis according to a first embodiment of the present invention;

[0037] Fig.11 It is a three-dimensional schematic diagram of a four-finger orthosis component in a hand rehabilitation orthosis in the first embodiment of the present invention;

[0038] Fig.12 It is a rear perspective schematic diagram of a finger sleeve in a hand rehabilitation orthosis according to a first embodiment of the present invention;

[0039] Fig.13 It is a left frontal stereoscopic schematic diagram of a finger sleeve in a hand rehabilitation orthosis according to a first embodiment of the present invention;

[0040] Fig.14 It is a three-dimensional schematic diagram of the middle finger pad covering structure of the hand rehabilitation orthosis in the first embodiment of the present invention;

[0041] Fig.15 is a schematic diagram of a pre-experimental process in a hand rehabilitation orthosis in a first embodiment of the present invention;

[0042] Fig.16 It is a schematic diagram of a prototype test of a passive orthosis in a hand rehabilitation orthosis in the first embodiment of the present invention;

[0043] Fig.17 It is a schematic diagram of a prototype of the hand rehabilitation orthosis in the first embodiment of the present invention;

[0044] Fig.18 is a schematic diagram of a finger ring structure in a hand rehabilitation orthosis in a first embodiment of the present invention;

[0045] Fig.19 It is a schematic diagram of a driving test experiment of the hand rehabilitation orthosis in the first embodiment of the present invention;

[0046] Fig. 20 This is a flow chart of a dynamic spasm monitoring method based on a hand rehabilitation orthosis in the second embodiment of the present invention.

[0047] Fig.21 Schematic diagram of the orthotic rehabilitation device driving control framework in the dynamic spasticity monitoring method based on the hand rehabilitation orthosis in the second embodiment of the present invention.

[0048] Component number description

[0049] 1. Orthopedic mechanism; 101. Palm support; 102. Thumb orthopedic assembly; 103. Four-finger orthopedic assembly; 2. Driving mechanism; 201. Micro electric push rod; 202. Thumb drive connecting rod; 203. Four-finger drive connecting rod; 204. Arm ring; 3. First thumb sleeve; 4. Second thumb sleeve; 5. Thumb support; 6. First thumb sleeve connecting rod; 7. Second thumb sleeve connecting rod; 8. First thumb support connecting rod; 9. 1. The second thumb support member connecting rod; 10. The first four-finger sleeve; 11. The second four-finger sleeve; 12. The third four-finger sleeve; 13. The first four-finger sleeve connecting rod; 14. The second four-finger sleeve connecting rod; 15. The third four-finger sleeve connecting rod; 16. The fourth four-finger sleeve connecting rod; 17. The first four-finger support member connecting rod; 18. The second four-finger support member connecting rod; 19. The first finger set; 20. The buckle assembly; 21. The second finger set; 22. The mounting plate; 23. The placement slot. DETAILED DESCRIPTION

[0050] The following specific embodiments illustrate the implementation of the present invention, and those familiar with the technology can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. It should be noted that the following embodiments and features in the embodiments can be combined with each other without conflict.

[0051] The first embodiment of the present invention relates to a hand rehabilitation orthosis, for details, please refer to Figures 1 to 5, comprising an orthotic mechanism 1 worn on a patient's hand and a driving mechanism 2 worn on a patient's arm and used to drive the orthotic mechanism 1; wherein the orthotic mechanism 1 comprises a palm support 101 located at the center of the patient's palm, a thumb orthotic assembly 102 movably connected to the palm support 101 and worn on the thumb, and a four-finger orthotic assembly 103 movably connected to the palm support 101 and worn on the remaining four fingers; the driving mechanism 2 comprises a plurality of micro electric push rods 201 used to drive the thumb orthotic assembly 102 and the four-finger orthotic assembly 103, wherein the plurality of micro electric push rods 201 are movably connected to the thumb orthotic assembly 102 and the four-finger orthotic assembly 103 through a thumb driving connecting rod 202 and a four-finger driving connecting rod 203, respectively, and an arm ring 204 for wearing on the patient's arm is installed at the end of the micro electric push rod 201 away from the driving connecting rod;

[0052] It should be noted that the drive design: In terms of the design of the drive mechanism 2, the four-bar linkage scheme of the passive orthosis is used for reference, and the motion characteristics of each finger joint are optimized. A planar four-bar linkage is used for the interphalangeal joint drive, and an additional degree of freedom is released at the metacarpophalangeal joint. Each finger is equipped with only one driving force source, and an under-actuated scheme is adopted (see Figure 6 ); The driving mechanism 2 is uniformly integrated in the palm area, which, on the one hand, provides sufficient activity space for the finger dorsiflexion movement, so that the fingers are not hindered during dorsiflexion training; on the other hand, it effectively avoids mechanical interference between adjacent fingers, ensuring the independence and coordination of the movement of each finger; The thumb driving connecting rod 202 adopts a ball-end connecting rod structure, which can better adapt to the unique movement requirements of the thumb, so that its movement direction is consistent with other fingers, and at the same time simplifies the complexity of the overall mechanism, and improves the reliability and stability of the driving mechanism 2;

[0053] In terms of drive motor selection, a micro electric push rod 201 (electric cylinder) is used. Its parameters, such as stroke, thrust, speed, power supply voltage, etc., are determined according to factors such as finger movement range, clinical rehabilitation traction force, movement smoothness and comfort. An arm ring 204 fixed structure is designed to solve the problem of multi-electric cylinder layout. The structure adopts an arc structure to fit the contour of the forearm and achieves comfortable fixation through adjustable straps. It can not only achieve a compact layout of five electric cylinders while ensuring stability, effectively avoiding mutual interference between electric cylinders, but also reserve cable wiring channels to facilitate the integration of subsequent control systems.

[0054] like Figures 7 to 9As shown, the thumb orthosis assembly 102 includes a first thumb sleeve 3, a second thumb sleeve 4 movably connected to the first thumb sleeve 3, and a thumb support 5 connected to the palm support 101. The first thumb sleeve 3 is also movably connected to the second thumb sleeve 4 through a first sleeve connecting rod assembly, and the second thumb sleeve 4 is movably connected to the thumb support 5 through a first thumb support connecting rod assembly. The thumb support 5 is also slidably connected to the thumb driving connecting rod 202; the first sleeve connecting rod assembly includes a first thumb sleeve connecting rod 6 movably connected to the first thumb sleeve 3 and a first thumb support connecting rod assembly connected to the first thumb sleeve 3. The second thumb sleeve connecting rod 7 is movably connected to the finger sleeve connecting rod 6, and the second thumb sleeve connecting rod 7 is also movably connected to the second thumb sleeve 4, and the movable connection between the first thumb sleeve connecting rod 6 and the second thumb sleeve connecting rod 7 is movably connected to the thumb driving connecting rod 202; the first thumb support member connecting rod assembly is divided into two groups, and each group of the first thumb support member connecting rod assembly includes a first thumb support member connecting rod 8 movably connected to the second thumb sleeve 4 and a second thumb support member connecting rod 9 movably connected to the first thumb support member connecting rod 8, and the second thumb support member connecting rod 9 is also movably connected to the thumb part support 5.

[0055] like Figure 7 , Figure 8 , Fig.10 and Fig.11 As shown, the four-finger orthosis component 103 includes a first four-finger sleeve 10, a second four-finger sleeve 11 movably connected to the first four-finger sleeve 10, and a third four-finger sleeve 12 movably connected to the second four-finger sleeve 11. The first four-finger sleeve 10, the second four-finger sleeve 11 and the third four-finger sleeve 12 are also movably connected through a second sleeve connecting rod assembly, and the third four-finger sleeve 12 is movably connected to the palm support 101 through a first four-finger support connecting rod 17 assembly; the first sleeve connecting rod and the second sleeve connecting rod both adopt a planar double four-bar linkage mechanism, and the second sleeve connecting rod assembly includes a first four-finger sleeve connecting rod 13 movably connected to the first four-finger sleeve 10, a second four-finger sleeve connecting rod 14 movably connected to the first four-finger sleeve connecting rod 13, and a second four-finger sleeve connecting rod 15 movably connected to the first four-finger sleeve connecting rod 15, respectively. The third four-finger sleeve link 15 movably connected to the sleeve link 14 and the fourth four-finger sleeve link 16 movably connected to the third four-finger sleeve link 15, the second four-finger sleeve link 14 is also movably connected to the second four-finger sleeve 11, the fourth four-finger sleeve link 16 is also movably connected to the third four-finger sleeve 12, and the movable connection between the third four-finger sleeve link 15 and the fourth four-finger sleeve link 16 is movably connected to the four-finger drive link 203; the first four-finger support member link 17 assembly is also divided into two groups, each group of the first four-finger support member link assemblies includes a first four-finger support member link 17 movably connected to the third four-finger sleeve 12 and a second four-finger support member link 18 movably connected to the first four-finger support member link 17, and the second four-finger support member link 18 is also movably connected to the palm support 101.

[0056] like Figure 12 to Figure 13 As shown, the first thumb sleeve 3, the second thumb sleeve 4, the first four-finger sleeve 10, the second four-finger sleeve 11 and the third four-finger sleeve 12 all include a first finger sleeve 19 in contact with the pulp of the patient's finger and a second finger sleeve 21 in contact with the back of the patient's finger. The first finger sleeve 19 and the second finger sleeve 21 are connected by a snap assembly 20. A force tactile sensing unit is installed on the side of the first finger sleeve 19 opposite to the second finger sleeve 21 through a pulp covering structure. The sensing contact of the force tactile sensing unit passes through the first finger sleeve 19 and contacts with the pulp of the patient's finger. Two mounting plates 22 integrally formed with the second finger sleeve 21 are connected to the side of the second finger sleeve 21 opposite to the first finger sleeve 19. A placement groove 23 for mounting an IMU sensor is formed between the two mounting plates 22 and the second finger sleeve 21.

[0057] It should be explained that, motion sensing design: in order to achieve accurate capture of hand movements during clinical rehabilitation manipulation therapy of patients, a hand motion posture capture system based on IMU sensors was constructed, the hardware and software designs were carefully planned, and its reliability was verified through preliminary experiments. In terms of hardware design, JY61P six-axis IMU sensor and JY901S nine-axis IMU sensor were selected as IMU sensors and force tactile sensing units made based on BMP280 sensors; according to the characteristics of finger movements, corresponding numbers of IMU sensors were installed on the four fingers and thumb, and fixed on the back of the fingers through finger rings, and corresponding numbers of force tactile sensing units were installed on the finger pads of the four fingers and thumb, and fixed on the inner side of the fingers through a covering structure. The finger pad covering structure is not displayed in the stereoscopic diagram corresponding to the hand rehabilitation orthosis in this embodiment. In actual applications, the finger pad covering structure is installed on the side of the first finger kit 19 opposite to the second finger kit 21, then the first finger sleeve connecting rod and the second finger sleeve connecting rod are directly and movably connected to the finger pad covering structure. For details about the finger pad covering structure, please refer to Fig.14 ;

[0058] The power supply and data acquisition scheme is designed based on the main control board. Two main control boards are used to connect multiple IMU sensors and force tactile sensing units. The IMU base and dedicated PCB board are designed to optimize the interface connection and system layout. In terms of software design, the data acquisition program obtains acceleration, angular velocity, angle and force tactile pressure data through the sensor's built-in communication protocol, and uses the Kalman filter algorithm to process the data to improve stability and accuracy. The sensor is statically calibrated before the experiment. In the experiment, the Python program is used to synchronously collect data from the two main control boards through serial communication and save them in txt format. The data sampling rate is about 25Hz, which meets the real-time requirements for hand motion capture and ensures that hand motion data can be obtained in a timely and accurate manner during rehabilitation treatment.

[0059] In the pre-experimental verification, the human index finger was selected as the test object, and the hand movement during the manual therapy was simulated by wearing IMU sensors at the joints of the index finger (see Fig.15 ); The experimental action design follows the principle of standardization, and the complete movement sequence is divided into three stages: flexion, dorsal extension, and return. The subjects start from the natural straight state of the fingers (0°), first complete the maximum flexion movement toward the palm (about 90°), then fully extend the dorsal direction (about -30°), and finally return to the initial natural position. The data acquisition stability and action repeatability of the system are verified.

[0060] Specifically, the mechanism design of the hand rehabilitation orthosis: through the kinematic analysis of the movement characteristics of human fingers, it was found that the planar four-bar structure and the planar double four-bar mechanism have potential in simulating the flexion and extension movement of fingers. After comprehensive consideration, the planar double four-bar mechanism was finally selected to simulate the multi-joint linkage movement; with the assistance of the Linkage mechanism simulation software, the mechanism parameters were continuously adjusted to make its motion trajectory match the actual motion trajectory of human fingers as much as possible.

[0061] When designing the specific structure, Solidworks 2021 Professional Edition software was used to first perform a detailed functional decomposition of the core functional modules of the orthosis, covering the orthosis mechanism, transmission system, fixed structure, and control unit. Based on the principles of ergonomics, each module was designed, focusing on key indicators such as structural strength, assembly accuracy, and motion interference. After the design was completed, the simulation function of the software was used to simulate the movement of the orthosis to discover possible problems in advance.

[0062] When making the prototype of the hand rehabilitation orthosis, manufacturing processes such as printing and machining were used to ensure the dimensional accuracy of the parts and control the manufacturing error of the key dimensions within a very small range. In order to ensure the practicality and applicability of the hand rehabilitation orthosis, clinical evaluation was carried out to verify the orthosis in three dimensions: functionality, ease of use, and comfort. In terms of functionality, the orthosis was examined to see whether it could meet the requirements of rehabilitation training for range of motion, speed, and fluency in actual use. In terms of ease of use, attention was paid to the ease of wearing of the orthosis, whether the overall weight was convenient for patients to use, and the difficulty of daily maintenance and cleaning. In terms of comfort, the focus was on evaluating the adaptability of the orthosis to the human body, including whether the contact area was reasonable, whether the pressure distribution was uniform, and whether long-term wearing would cause discomfort.

[0063] The final design adopts an open-type wearing structure on the back of the hand, which is convenient for patients to wear and can be directly embedded in the device from above. At the same time, a special buckle mechanism is integrated to firmly fix the IMU sensor in the optimal position, ensuring high-precision data collection without affecting the patient's comfort and operating experience. In addition, a fingertip covering structure is provided to firmly fix the force tactile sensing unit in a preset position, ensuring efficient collection of force tactile pressure data without affecting the patient's normal wearing experience. The main structure of the hand rehabilitation orthosis is reasonably arranged in the palm area. Such a layout is convenient for therapists to implement hand dorsiflexion training and can effectively avoid interference between fingers. In the design of the kinematic mechanism, a four-bar linkage is used to control the distal interphalangeal joints, and a certain degree of freedom is released at the metacarpophalangeal joints, so that the fingers can move flexibly in a larger range to meet the needs of different rehabilitation movements. In addition, the kinematic mechanism is manufactured through metal processing, which further improves the structural strength and rigidity and reduces the interference between adjacent fingers. For details, please refer to Fig.16 ;

[0064] In terms of prototype production and integration, additive manufacturing technology is used, and resin materials and stainless steel metal are selected as the printing materials for the hand contact part and the drive mechanism 2 respectively to achieve lightweight design; a modular integration strategy is used to assemble the drive system to ensure that the installation accuracy of the electric cylinder and the clearance of the kinematic pair meet the design specifications (see Figures 1 to 3 and Fig.17 ); In terms of motion sensing system integration, a standardized IMU sensor and force tactile sensing unit installation method is designed, a precision buckle structure is used to ensure the precise positioning of the IMU sensor, and a fingertip covering structure is set to ensure the firm fixation of the force tactile sensing unit (see Fig.14 and Fig.18 ), design a multi-channel sensor signal transmission solution based on a flexible printed circuit board to improve system integration and signal transmission reliability; after testing, the prototype meets the design requirements in terms of drive accuracy, motion coordination, comfort and stability (see Fig.19 ).

[0065] The second embodiment of the present invention relates to a dynamic spasticity monitoring method based on hand rehabilitation orthosis, the process is as follows: Fig. 20 As shown, the details are as follows:

[0066] Step 101, using an integrated sensor including a surface electromyography sensor and an IMU sensor to collect the surface electromyography signal and inertial measurement data of the patient during each treatment, and at the same time, the doctor uses a spasm level assessment method to score the spasm level of the patient during each treatment.

[0067] Step 102, obtain force tactile pressure data and inertial measurement data and use them as input, obtain the spasm grade score rated by the doctor and use it as output, use the force tactile pressure data, inertial measurement data and spasm grade score to train the initial spasm grade prediction model, and obtain the spasm grade prediction model based on the training results.

[0068] Specifically, during the experimental design and data collection phase, 11 patients with hand spasticity after stroke were recruited from the occupational therapy room of Xuzhou Rehabilitation Hospital to conduct the experiment; using surface electromyography sensors, an armband 204 was designed to wear 9 sEMG sensors on 9 specific muscles (such as radial extensor carpi, flexor pollicis longus, etc.) of the patient's affected arm, and the sampling frequency was set to 4000Hz; during the experiment, the therapist performed 8 therapeutic movements (wrist stretching, four-finger stretching, etc.) on the patient, and each movement was repeated 6 times. After each movement, the MAS scale was used to evaluate the hand muscle tension and collect EMG signals; in order to improve the precision of spasticity assessment, a new spasticity level assessment method was introduced;

[0069] In the data processing stage, the MATLAB R2023a platform is used to process the collected data. First, a bandpass filter is used to reduce noise within a suitable frequency range to remove interference information; then, a specific detection method is used to extract the action interval, and manual verification is performed to ensure the accuracy of the data; then, a series of time domain eigenvalues ​​are extracted, which include but are not limited to RMS, MAV, iEMG, A-ApA and other electromyographic signal characteristics for subsequent analysis. When constructing the prediction model, a supervised learning method is used to map the data, action sequence labels are introduced to reflect the timing information, and pre-processing operations such as standardization and downsampling are performed on the data. Finally, the processed surface electromyography data is used as input, and the MAS grade score is used as output;

[0070] In the model architecture and training stage, a spasticity level prediction model is proposed. The model extracts features from multi-channel IMU data and action sequence labels, processes each channel data through a convolution module, compresses the time dimension, expands the number of feature channels, and forms a unified feature representation. After that, the data is spliced ​​and reorganized, and a recurrent neural network is introduced to mine the temporal dependency relationship. Finally, the MAS score prediction value is output through a fully connected layer and a regressor. The model uses the root mean square error (RMSE) as the loss function and uses the Adam optimizer for training.

[0071] Step 103, obtaining force tactile pressure data and inertial measurement data of the patient who is receiving treatment with a hand rehabilitation orthosis, collected by a force tactile sensing unit and an IMU sensor.

[0072] Step 104, input the force tactile pressure data and inertial measurement data into the spasticity level prediction model, obtain the patient's spasticity level through the spasticity level prediction model, obtain the pre-set treatment strategy corresponding to the spasticity level, and use the force tactile pressure data and inertial measurement data in the treatment strategy as the rehabilitation training baseline trajectory, and control the hand rehabilitation orthosis to perform rehabilitation movements through a multi-level control architecture.

[0073] Specifically, in terms of drive control, a closed-loop drive control solution based on multimodal data fusion is adopted to integrate surface electromyography signals and inertial measurement data. The system uses 9-channel surface electromyography signals as physiological feature input, which are input into the spasticity level prediction model after action interval extraction to evaluate the patient's spasticity state. At the same time, the IMU data and force tactile pressure data of the therapist's manual treatment are used as the benchmark trajectory for rehabilitation training. Through a multi-level control architecture, the treatment strategy is intelligently selected and dynamically adjusted to generate an adaptive target trajectory. The position controller outputs drive instructions to regulate the orthosis mechanism to perform rehabilitation movements. The system constructs a dual closed-loop feedback mechanism of kinematic feedback loops and physiological feedback loops to monitor the hand movement state and muscle spasm level in real time and adaptively adjust the rehabilitation training plan. For details, please refer to Fig.21 .

[0074] In summary, the key technical points of the present invention are: the first is the construction of a dynamic monitoring model for spasticity level: the present invention collects 70 manual therapy experimental data from 11 patients through rigorous experimental design, obtains surface electromyography data of 9 hand muscles with the help of surface electromyography sensors, and combines continuous MAS scores to analyze the correlation between surface electromyography signal characteristics and changes in spasticity level; on this basis, an innovative spasticity level prediction model is constructed, which uses surface electromyography signals as input to achieve real-time prediction of spasticity level; this model breaks the limitations of traditional discrete evaluation, provides a scientific basis for the dynamic rehabilitation strategy of rehabilitation orthotics, and can effectively assist doctors to accurately control the changes in patient spasticity and adjust the rehabilitation plan in time.

[0075] The second is the design of orthosis mechanism based on dynamic monitoring: according to the movement characteristics of human hands, the present invention uses Linkage mechanism simulation software, compares various linkage mechanisms, and adopts a planar double four-bar linkage mechanism to simulate the finger movement trajectory, and optimizes the length ratio of the linkage and the position of the hinge point; through the iterative development mode of "digital modeling-prototype production-clinical verification", it is continuously optimized according to clinical evaluation feedback. The final open-type wearing structure on the back of the hand integrates a special buckle to fix the IMU sensor, designs a fingertip covering structure to fix the force tactile sensing unit, and reasonably arranges the main structure in the palm area, releasing the degree of freedom at the metacarpophalangeal joint, which not only improves the wearing convenience and data collection accuracy, but also meets the needs of different rehabilitation movements and improves the patient's experience.

[0076] The third is the orthosis drive control scheme of multimodal data fusion: the present invention adopts a closed-loop drive control scheme based on the fusion of surface electromyography signals and inertial measurement data; the system uses 9-channel surface electromyography signals to evaluate the patient's spasticity state, and uses the IMU data and force tactile pressure data of the therapist's manual treatment as the baseline trajectory for rehabilitation training. Through a multi-level control architecture, the treatment strategy is intelligently selected and adjusted according to the real-time spasticity level and standard treatment mode, and an adaptive target trajectory is generated. The position controller drives the orthosis mechanism to perform rehabilitation movements; at the same time, a kinematic and physiological dual closed-loop feedback mechanism is constructed to monitor the hand movement state and muscle spasm activity level in real time, realize comprehensive perception and adaptive adjustment of the rehabilitation process, and significantly improve the intelligence level and treatment effect of rehabilitation training.

[0077] The above embodiments are merely illustrative of the principles and effects of the present invention, and are not intended to limit the present invention. All equivalent modifications or changes made by those skilled in the art without departing from the spirit and technical ideas disclosed by the present invention shall still be covered by the claims of the present invention.

Claims

1. A hand rehabilitation orthosis, characterized in that: It comprises an orthotic mechanism (1) worn on a patient's hand and a driving mechanism (2) worn on the patient's arm and used to drive the orthotic mechanism (1); The orthotic mechanism (1) comprises a palm support (101) located at the center of the patient's palm, a thumb orthotic component (102) movably connected to the palm support (101) and worn on the thumb, and a four-finger orthotic component (103) movably connected to the palm support (101) and worn on the remaining four fingers; The driving mechanism (2) comprises a plurality of micro electric push rods (201) for driving the thumb orthosis component (102) and the four-finger orthosis component (103); the plurality of micro electric push rods (201) are movably connected to the thumb orthosis component (102) and the four-finger orthosis component (103) via a thumb driving connecting rod (202) and a four-finger driving connecting rod (203), respectively; an arm ring (204) for being worn on a patient's arm is installed at the end of the micro electric push rod (201) away from the driving connecting rod.

2. A hand rehabilitation orthosis according to claim 1, characterized in that: The thumb orthosis component (102) comprises a first thumb sleeve (3), a second thumb sleeve (4) movably connected to the first thumb sleeve (3), and a thumb support (5) connected to the palm support (101); the first thumb sleeve (3) is also movably connected to the second thumb sleeve (4) via a first sleeve connecting rod component; the second thumb sleeve (4) is movably connected to the thumb support (5) via a first thumb support connecting rod component; and the thumb support (5) is also slidably connected to the thumb driving connecting rod (202).

3. A hand rehabilitation orthosis according to claim 2, characterized in that: The first thumb sleeve connecting rod assembly comprises a first thumb sleeve connecting rod (6) movably connected to the first thumb sleeve (3) and a second thumb sleeve connecting rod (7) movably connected to the first thumb sleeve connecting rod (6); the second thumb sleeve connecting rod (7) is also movably connected to the second thumb sleeve (4); and the movably connected portion between the first thumb sleeve connecting rod (6) and the second thumb sleeve connecting rod (7) is movably connected to the thumb driving connecting rod (202).

4. A hand rehabilitation orthosis according to claim 2, characterized in that: The first thumb support link assembly comprises two groups, each group of the first thumb support link assembly comprises a first thumb support link (8) movably connected to the second thumb sleeve (4) and a second thumb support link (9) movably connected to the first thumb support link (8), and the second thumb support link (9) is also movably connected to the thumb support (5).

5. The hand rehabilitation orthosis according to claim 2, characterized in that: The four-finger orthosis component (103) comprises a first four-finger sleeve (10), a second four-finger sleeve (11) movably connected to the first four-finger sleeve (10), and a third four-finger sleeve (12) movably connected to the second four-finger sleeve (11); the first four-finger sleeve (10), the second four-finger sleeve (11) and the third four-finger sleeve (12) are movably connected via a second sleeve connecting rod component; and the third four-finger sleeve (12) is movably connected to the palm support component (101) via a first four-finger support component connecting rod component.

6. A hand rehabilitation orthosis according to claim 5, characterized in that: The first finger sleeve connecting rod and the second finger sleeve connecting rod both adopt a planar double four-bar connecting rod mechanism, and the second finger sleeve connecting rod assembly comprises a first four-finger sleeve connecting rod (13) movably connected to the first four-finger sleeve connecting rod (10), a second four-finger sleeve connecting rod (14) movably connected to the first four-finger sleeve connecting rod (13), a third four-finger sleeve connecting rod (15) movably connected to the first four-finger sleeve connecting rod (13) and the second four-finger sleeve connecting rod (14) respectively, and a fourth four-finger sleeve connecting rod (16) movably connected to the third four-finger sleeve connecting rod (15); The second four-finger sleeve connecting rod (14) is also movably connected to the second four-finger sleeve (11), the fourth four-finger sleeve connecting rod (16) is also movably connected to the third four-finger sleeve (12), and the movable connection point between the third four-finger sleeve connecting rod (15) and the fourth four-finger sleeve connecting rod (16) is movably connected to the four-finger driving connecting rod (203).

7. The hand rehabilitation orthosis according to claim 5, characterized in that: The first four-finger support member link assembly also consists of two groups, and each group of the first four-finger support member link assembly includes a first four-finger support member link (17) movably connected to the third four-finger sleeve (12) and a second four-finger support member link (18) movably connected to the first four-finger support member link (17), and the second four-finger support member link (18) is also movably connected to the palm support member (101).

8. The hand rehabilitation orthosis according to claim 5, characterized in that: The first thumb sleeve (3), the second thumb sleeve (4), the first four-finger sleeve (10), the second four-finger sleeve (11) and the third four-finger sleeve (12) all comprise a first finger sleeve (19) in contact with the pulp of the patient's finger and a second finger sleeve (21) in contact with the back of the patient's finger, and the first finger sleeve (19) and the second finger sleeve (21) are connected via a buckle assembly (20); A force tactile sensing unit is installed on the side of the first finger kit (19) opposite to the second finger kit (21) through a finger pad covering structure, and the sensing contact of the force tactile sensing unit passes through the first finger kit (19) and contacts the finger pad of the patient's finger. The side of the second finger kit (21) opposite to the first finger kit (19) is connected to two mounting plates (22) integrally formed with the second finger kit (21), and a placement groove (23) for mounting an IMU sensor is formed between the two mounting plates (22) and the second finger kit (21).

9. A method for monitoring dynamic spasm of a hand rehabilitation orthosis based on any one of claims 1 to 8, characterized in that: The method comprises the following steps: Acquiring force tactile pressure data and inertial measurement data of a patient receiving treatment with a hand rehabilitation orthosis collected by a force tactile sensing unit and an IMU sensor, wherein the force tactile pressure data and inertial measurement data are integrated by adopting a closed-loop drive control method based on multimodal data fusion; The force, tactile, pressure data and inertial measurement data are input into a spasticity level prediction model, the patient's spasticity level is obtained through the spasticity level prediction model, a pre-set treatment strategy corresponding to the spasticity level is obtained, and the force, tactile, pressure data and inertial measurement data in the treatment strategy are used as a reference trajectory for rehabilitation training, and the hand rehabilitation orthosis is regulated to perform rehabilitation movements through a multi-level control architecture.

10. A dynamic spasticity monitoring method based on hand rehabilitation orthosis according to claim 9, characterized in that: Before acquiring the force tactile pressure data and inertial measurement data of the patient who is treated with the hand rehabilitation orthosis collected by the force tactile sensing unit and the IMU sensor, the method further includes: An integrated sensor including a surface electromyography sensor and an IMU sensor is used to collect the patient's surface electromyography signal and inertial measurement data during each treatment. At the same time, the doctor uses the spasticity level assessment method to score the patient's spasticity level for each treatment. The force tactile pressure data and the inertial measurement data are obtained and used as input, the spasm grade score evaluated by the doctor is obtained and used as output, an initial spasm grade prediction model is trained using the force tactile pressure data, the inertial measurement data and the spasm grade score, and a spasm grade prediction model is obtained according to the training results; Among them, before the force tactile pressure data and inertial measurement data are input into the initial spasm level prediction model, it also includes: first reducing the noise of the force tactile pressure data and inertial measurement data; then using a dual-threshold based detection method to extract the action interval and manually verify it; then extracting the time domain feature value, the time domain feature value includes but is not limited to RMS, MAV, iEMG and A-ApA and other electromyographic signal characteristics.

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