Wrist-worn device to encourage use of the weaker arm after a recent stroke
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Subacute Stroke Survivors
This trial tests whether a wrist-worn sensor system plus motor and behavioral home coaching helps people 1–6 months after a stroke with moderate arm weakness use their affected arm more than a usual home-exercise program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06797154 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–85 with an anterior circulation ischemic stroke 1–6 months earlier, unilateral upper-extremity hemiparesis with FMA-UE scores 20–45 and SAFE ≥5, intact cognition, and ownership/use of a smartphone are ideal candidates.
Not a fit: Patients with severe spasticity (Modified Ashworth ≥3), visual field loss or hemispatial neglect, lack of smartphone access, or very mild/very severe arm impairment outside the trial's FMA range are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, the wearable plus coaching could increase everyday use and function of the affected arm and improve independence in daily activities.
How similar studies have performed: Early pilot studies of wearable activity sensors combined with behavioral coaching for post-stroke arm use have shown promising results, but large randomized trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.