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

NCT07737431 | Recruiting

• 1 other identifier: GRF15218324
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (4)

• EMG Co-contraction Index During Wrist-Hand Tasks

  At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training

• Dynamic Neuromuscular Network Functional Connectivity

  At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training

• Peak Beta-Band Corticomuscular Coherence Value

  At the pre-training assessment, immediately after completion of the 20 training sessions, and 3 months after completion of training

Study Arms (2)

Closed-Loop Sensorimotor Integrated Group

EXPERIMENTAL

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 Group

ACTIVE 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

Interventions

CSMI-Controlled ENMS DEVICE

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.

Closed-Loop Sensorimotor Integrated Group

EMG-Driven ENMS DEVICE

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.

EMG-Driven Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xiaoling Hu, Phd

CONTACT

852 3400 3206; xiaoling.hu@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

HK (1)