Neuro-Intermuscular Coordination Enhancement (NICE) Rehabilitation Through Human-Machine Interaction in Chronic Stroke
United States48 participantsStarted 2027-08
Plain-language summary
The objective of this study is to develop Neuro-Intermuscular Coordination Enhancement (NICE) rehabilitation, a novel neuromuscular control signal-guided strategy that visually guides stroke patients to individually activate motor modules through human-machine interaction. Ultimately, the development will lead to better clinical motor recovery, better quality of life, and lowered healthcare costs associated with the impairment.
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria for individuals after stroke are:
* Hemiparetic chronic stroke survivors more than 6 months after stroke onset
* Adults aged 21-80 years, including both female and male participants
* Individuals with a single unilateral ischemic or hemorrhagic stroke
* Individuals with Upper Extremity Fugl-Meyer Assessment score between 10 and 59 out of 66
* Individuals who have not received botulinum toxin injections in the upper extremity within the past 3 months
* Individuals without severe spasticity, defined as Modified Ashworth Scale score ≤3 at the elbow and shoulder
Exclusion criteria for individuals after stroke are:
* Individuals younger than 21 years of age or older than 80 years of age
* Individuals with an orthopedic disorder involving the upper limbs
* Individuals unable to produce voluntary upper-extremity muscle EMG activity;
* Individuals with cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol, assessed using the Montreal Cognitive Assessment or other IRB-approved screening procedures.
* Individuals whose stroke-affected arm has an intermuscular coordination pattern similarity score \>0.80 relative to the non-affected arm
Inclusion criteria for healthy individuals are:
* Healthy adults aged 21-80 years, including both female and male participants
* Individuals with no known neurological or orthopedic injuries
Exclusion criteria for healthy individuals are:
* Individuals younger than 21 years o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fugl-Meyer Assessment (FMA) score
Timeframe: Baseline, six- week, 10-week, and 18-week follow-ups.