NCT07737431 Closed-loop Sensorimotor Integrated (CSMI) Control in Exoneuromusculoskeleton (ENMS) for Precise Wrist-hand Rehabilitation After Stroke
| NCT ID | NCT07737431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07737431 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 70 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07737431 currently recruiting?
Yes, NCT07737431 is actively recruiting participants. Contact the research team at xiaoling.hu@polyu.edu.hk for enrollment information.
Where is the NCT07737431 trial being conducted?
This trial is being conducted at Hung Hom, Hong Kong.
Who is sponsoring the NCT07737431 clinical trial?
NCT07737431 is sponsored by The Hong Kong Polytechnic University. The trial plans to enroll 48 participants.
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