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NCT Number: NCT07737431

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

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.

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Key information

Conditions

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

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Location status: Recruiting

Location contact

Xiaoling Hu, Phd

CONTACT

[email protected]

852 3400 3206

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

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.

Primary outcomes

  1. Fugl-Meyer Assessment Wrist/Hand Subscale (FMA-WH) Score

    Time frame: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training

    The Fugl-Meyer Assessment Wrist and Hand Subscore (FMA-WH) evaluates motor impairment of the paretic wrist and hand after stroke. The score ranges from 0 to 24, including a maximum of 10 points for wrist function and 14 points for hand function. Higher scores indicate better wrist-hand motor function.

Secondary outcomes

  1. Finger Spasticity Assessed by the Modified Ashworth Scale (MAS)

    Time frame: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training

    The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers. Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity.

  2. Wrist Spasticity Assessed by the Modified Ashworth Scale (MAS)

    Time frame: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training

    The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers. Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity.

  3. Elbow Spasticity Assessed by the Modified Ashworth Scale (MAS)

    Time frame: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training

    The Modified Ashworth Scale (MAS) evaluates resistance to passive movement as an indicator of muscle tone and spasticity at the fingers. Possible grades are 0, 1, 1+, 2, 3, and 4, with a minimum grade of 0 and a maximum grade of 4. Higher grades indicate greater resistance to passive movement and more severe spasticity.

  4. Fugl-Meyer Assessment Shoulder/Elbow Subscale Score

    Time frame: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training

    The Fugl-Meyer Assessment Shoulder/Elbow Subscore evaluates proximal upper-extremity motor impairment, including movements of the shoulder, elbow, and forearm. The score ranges from 0 to 36. Higher scores indicate better proximal upper-extremity motor function.

  5. Action Research Arm Test (ARAT) Score

    Time frame: At three pre-training assessments conducted over 2 weeks, immediately after completion of the 20 training sessions, and 3 months after completion of training

    The Action Research Arm Test (ARAT) evaluates upper-extremity activity performance through 19 items covering grasp, grip, pinch, and gross movement. The total score ranges from 0 to 57. Higher scores indicate better upper-extremity activity performance.

Other outcomes

  1. EMG Co-contraction Index During Wrist-Hand Tasks

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

  2. Dynamic Neuromuscular Network Functional Connectivity

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

  3. Peak Beta-Band Corticomuscular Coherence Value

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

  4. Cortical Location of Peak Beta-Band Corticomuscular Coherence

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoling Hu, Phd

CONTACT

[email protected]

852 3400 3206

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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