Wrist-worn device to encourage use of the weaker arm after a recent stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm randomized trial lasting six months that compares the StrokeWear wrist sensor plus a motor and behavioral home intervention with a usual-care home exercise plan. Participants are stratified by baseline motor impairment and time since stroke and are evaluated at baseline, 3 months, and 6 months using measures across the ICF model. The intervention group receives a structured coaching schedule (weekly in month 1, biweekly in months 2–3, and monthly in months 4–6) delivered in-person or remotely by preference, while the control group receives monthly check-ins to update the home exercise program. Upper-extremity motor function and real-world arm use are the primary targets of measurement.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

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 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's running

• Spaulding Rehabilitation Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Paolo Bonato, PhD — Spaulding Rehabilitation Hospital
• Study coordinator: Paolo Bonato, PhD
• Email: pbonato@partners.org
• Phone: 617-952-6319

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.