Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Sur… (NCT05626894) | Clinical Trial Compass
RecruitingPhase 2
Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
United States32 participantsStarted 2025-03-20
Plain-language summary
The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in chronic stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).
Who can participate
Age range
18 Years – 85 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:
* Male or female, 18-85 years of age at the time of enrollment;
* Anterior circulation ischemic stroke at least 6 months and up to 5 years prior to study enrollment;
* Unilateral upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 20 and 45;
* Intact cognitive function to understand the study procedures and goal setting (MMSE score above 23 and able to follow 3 step command);
* Being familiar and comfortable with the use of a tablet or smartphone.
Exclusion Criteria:
* Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe performance of UE tasks;
* Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject ability to see feedback on the app screen (as assessed with the star cancellation test);
* Individuals with open wounds or recent fracture (less than 3 months) in the UE, fragile skin or active infection as evaluated by the study therapist;
* Individuals currently enrolled in a UE rehabilitation program (i.e., OT, research study)
* Upper-extremity orthopedic injuries or severe pain resulting in movement limitations;
* Diagnosis of other neurological disease (i.e., Parkinson's disease, multiple sclerosis, ...);
* Severe proprioceptive deficits that impair the ability to process the vibration fe…
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
Change in Motor Activity Log-Amount of Use
Timeframe: Change from baseline Motor Activity Log-Amount of Use score at 6 months
2
Change in Fugl-Meyer Upper-Extremity
Timeframe: Change from baseline Fugl-Meyer Upper-Extremity score at 6 months
3
Change in Upper-Extremity Activity Counts
Timeframe: Change from baseline Upper-Extremity Activity Counts score at 6 months