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Closed-loop Sensorimotor Integrated (CSMI) Control in Exoneuromusculoskeleton (ENMS) for Precise Wrist-hand Rehabilitation After Stroke

RecruitingNAAges 30 Years - 70 YearsAllThe Hong Kong Polytechnic University
NCT07737431 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 wr

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📋 Eligibility rules (as published)
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.).
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What it tests

  • CSMI-Controlled ENMS
  • EMG-Driven ENMS
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Where

1 site
The Hong Kong Polytechnic University
Hung Hom, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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