Wrist sensor system to increase use of the weak arm at home after stroke

A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Chronic Stroke Survivors

This program will test whether wearing the StrokeWear wrist sensor combined with a motor and behavioral home program helps chronic stroke survivors with hemiparesis use their affected arm more than a standard home-exercise plan.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Spaulding Rehabilitation Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05626894 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–85 with unilateral upper-extremity hemiparesis from an anterior circulation ischemic stroke 6 months to 5 years earlier, FMA-UE scores between 20 and 45, intact cognition (MMSE >23 and able to follow commands), and comfortable using a smartphone or tablet.

Not a fit: Patients with severe spasticity (Modified Ashworth Scale ≥3), significant visual field loss or hemispatial neglect, or notable cognitive impairment are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could increase everyday use of the impaired arm and improve functional independence for chronic stroke survivors.

How similar studies have performed: Previous small studies and pilot programs using wearable sensors and behaviorally guided home rehabilitation have shown promising signals for increasing arm use, but large randomized phase 2 evidence is still limited.

Eligibility criteria

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 this trial is running

Boston, Massachusetts

• Spaulding Rehabilitation Hospital Boston — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Paolo Bonato, PhD — Spaulding Rehabilitation Hospital
• Study coordinator: Paolo Bonato, PhD

Conditions Stroke; Stroke Sequelae; Hemiparesis; Poststroke/CVA; StrokeWear; BioSensics; Behavioral intervention