Closed-loop Sensorimotor Integrated (CSMI) Control in Exoneuromusculoskeleton (ENMS) for Precise Wrist-hand Rehabilitation After Stroke | NCT07737431

NCT07737431

Overview

NCT ID: NCT07737431
Lead Sponsor: The Hong Kong Polytechnic UniversityOTHER
Official Title: Closed-loop Sensorimotor Integrated (CSMI) Control in Exoneuromusculoskeleton (ENMS) for Precise Wrist-hand Rehabilitation After Stroke
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.

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Jan 1, 2025Actual
Primary Completion Date: Dec 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

at least 6 months after the onset of a unilateral lesion due to stroke;

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);

sensory impairment on their affected forearm with a score of 1 measured by the sensation part of light touch in the FMA;

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);

sufficient cognition to follow experimental instructions (Mini-Mental State Examination score >21);

aged from 30 to 70 years.

Exclusion Criteria:

currently pregnant;

dysphasia (language deficiency);

skull implantation;

post-stroke neglect;

pacemaker implantation;

involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb;

the overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 48Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Xiaoling Hu, PhdContact
xiaoling.hu@polyu.edu.hk852 3400 3206

Similar Studies

Participant Group/Arms

Closed-Loop Sensorimotor Integrated GroupExperimental

Participants will receive 20 sessions of wrist-hand rehabilitation using an exoneuromusculoskeleton (ENMS). In this group, corticomuscular coherence (CMC) and electromyographic (EMG) signals will be used together to identify voluntary movement intention and control neuromuscular electrical stimulation and robotic assistance during wrist and hand movements.

Device: CSMI-Controlled ENMS

EMG-Driven GroupActive Comparator

Participants will receive 20 sessions of wrist-hand rehabilitation using the same exoneuromusculoskeleton (ENMS). In this group, electromyographic (EMG) activity alone will be used to identify voluntary movement intention and control neuromuscular electrical stimulation and robotic assistance during wrist and hand movements.

Device: EMG-Driven ENMS