Wrist sensor system to increase use of the weak arm at home after 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 Phase 2 trial lasting six months comparing the StrokeWear system plus a motor and behavioral home intervention against a usual-care home exercise plan. Participants will have outcome evaluations at baseline, 3 months, and 6 months, and groups are stratified by baseline motor impairment and stroke chronicity. The intervention arm receives frequent coaching (weekly in month 1, bi-weekly in months 2–3, monthly in months 4–6) delivered in person or remotely, while the control arm receives monthly visits to update their home-exercise plan. Upper-extremity motor function will be measured across ICF domains (including FMA-UE) and participants must be able to use a tablet or smartphone and have intact cognition.

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 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 feedback, as assessed by physical examination during screening as assessed by the study therapist;
* Not understanding spoken or written English;
* Recent (less than 3 months) Botox injection in the UE or plan to undergo injections during the study timeline;
* Contralateral motor deficits as assessed by clinical examination;
* Brainstem and cerebellar stroke.

Where it's running

• Spaulding Rehabilitation Hospital Boston
  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

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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.