Closed-loop brain-muscle control with a wrist-hand rehabilitation robot after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will compare two approaches to wrist-hand rehabilitation with an exoneuromusculoskeleton: one using combined brain and muscle signals to guide electrical stimulation and robotic assistance, and another using muscle activity alone. Forty-eight participants with chronic unilateral stroke and moderate to severe wrist-hand impairment will receive 20 rehab sessions. Outcomes will show whether brain-muscle control provides superior improvements in motor function over EMG-driven control. The study will be conducted at The Hong Kong Polytechnic University.

Why it matters

Who can join: the full rules

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.).

Where it's running

• The Hong Kong Polytechnic University
  Hung Hom, Kowloon, Hong Kong Recruiting

Study contacts

• Study coordinator: Xiaoling Hu, Phd
• Email: xiaoling.hu@polyu.edu.hk
• Phone: 852 3400 3206

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.