Stroke
Conditions
Brief summary
The goal of this randomized controlled trial is to determine whether using both brain and muscle signals to control a wrist-hand rehabilitation robot can improve recovery in people with chronic stroke. A total of 48 participants will be randomly assigned to one of two groups. Both groups will receive 20 sessions of wrist-hand rehabilitation using an exoneuromusculoskeleton rehabilitation robot. In the closed-loop sensorimotor integrated group, the system will use information from both brain-muscle coordination and muscle activity to recognize the participant's movement intention and provide electrical stimulation and robotic assistance. In the electromyography-driven group, the system will use muscle activity alone to control the electrical stimulation and robotic assistance. The main questions this study aims to answer are: Does control using both brain and muscle signals improve wrist and hand motor function more than control using muscle signals alone? Does this approach produce greater changes in coordination between the brain and muscles? Participants will complete motor-function and brain-muscle assessments before training, immediately after the 20 training sessions, and 3 months after training.
Interventions
DEVICECSMI-Controlled ENMS
The exoneuromusculoskeleton (ENMS) provides neuromuscular electrical stimulation and robotic assistance for wrist-hand rehabilitation. In the CSMI-controlled intervention, corticomuscular coherence and electromyographic signals are jointly used to identify voluntary movement intention and trigger assistance. Participants will receive 20 training sessions.
DEVICEEMG-Driven ENMS
The exoneuromusculoskeleton (ENMS) provides neuromuscular electrical stimulation and robotic assistance for wrist-hand rehabilitation. In the EMG-driven intervention, electromyographic activity alone is used to identify voluntary movement intention and trigger assistance. Participants will receive 20 training sessions.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. at least 6 months after the onset of a unilateral lesion due to stroke; 2. moderate to severe motor disability in the paretic wrist-hand joints (6\<Fugl-Meyer Wrist-Hand Assessment (FMAWH)\<14) and spasticity in wrist-hand (Modified Ashworth Score (MAS) ≤3); 3. sensory impairment on their affected forearm with a score of 1 measured by the sensation part of light touch in the FMA; 4. maximal voluntary contraction (MVC) with detectable EMG (3 times of the standard deviation above the resting EMG baseline) in the muscle union of the flexor digitorum and flexor carpi radialis (FD-FCR) and that of the extensor digitorum and extensor carpi ulnaris (ED-ECU); 5. sufficient cognition to follow experimental instructions (Mini-Mental State Examination score \>21); 6. aged from 30 to 70 years.
Exclusion criteria
1. currently pregnant; 2. dysphasia (language deficiency); 3. skull implantation; 4. post-stroke neglect; 5. pacemaker implantation; 6. involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb; 7. the overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score | At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training | The Fugl-Meyer Assessment Wrist and Hand Subscore (FMA-WH) evaluates motor impairment of the paretic wrist and hand after stroke. The score ranges from 0 to 24, including a maximum of 10 points for wrist function and 14 points for hand function. Higher scores indicate better wrist-hand motor function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Finger Spasticity Assessed by the Modified Ashworth Scale (MAS) | At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training | The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers. Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity. |
| Wrist Spasticity Assessed by the Modified Ashworth Scale (MAS) | At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training | The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers. Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity. |
| Elbow Spasticity Assessed by the Modified Ashworth Scale (MAS) | At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training | The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers. Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity. |
| Fugl-Meyer Assessment Shoulder/Elbow Subscale Score | At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training | The Fugl-Meyer Assessment Shoulder/Elbow Subscore evaluates proximal upper-extremity motor impairment, including movements of the shoulder, elbow, and forearm. The score ranges from 0 to 36. Higher scores indicate better proximal upper-extremity motor function. |
| Action Research Arm Test (ARAT) Score | At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training | The Action Research Arm Test (ARAT) evaluates upper-extremity activity performance through 19 items covering grasp, grip, pinch, and gross movement. The total score ranges from 0 to 57. Higher scores indicate better upper-extremity activity performance. |
Countries
Hong Kong
Contacts
CONTACTXiaoling Hu, Phd
Outcome results
None listed