RecruitingStrokeStroke SequelaeHemiparesis;Poststroke/CVA

Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors

Eligible age

18–85 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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).

Sponsor: Spaulding Rehabilitation Hospital

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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 feedback, as assessed by physical examination during screening as assessed by the study therapist;
✕ Not understanding spoken or written English;

Where it's recruiting

Massachusetts

Boston

Source: ClinicalTrials.gov · NCT05626894 · last updated 2025-11-28