A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Stroke, Stroke Sequelae, Hemiparesis;Poststroke/CVA
In brief
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 subacute 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).
Key facts
- Study ID
- NCT06797154
- Run by
- Spaulding Rehabilitation Hospital
- People needed
- 88
- Starts
- 2025-08-08
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2025-11-28
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, 18-85 years of age at the time of enrollment
- Anterior circulation ischemic stroke at least 1 month and no more than 6 months 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 3step command) ;
- Owning a smartphone (iOS or Android) and being familiar and comfortable with and owning a tablet or smartphone
- SAFE score equal or greater than 5
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 the feedback on the app screen (as assessed with the Mesulum cancellation test);
- Individuals with open wounds or recent fracture (less than 3 months) in the upper extremity, fragile skin or active infection;
- 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;
- Not understanding spoken or written English;
- Contralateral motor deficits as assessed by clinical examination;
- Brainstem and cerebellar stroke.
Where it is running
- Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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