NCT05626894RecruitingPhase 2
Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Chronic Stroke Survivors
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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 chronic 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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 6 Nov 2022
- Start date
- 20 Mar 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Diseases
- Stroke
- NCT number
- NCT05626894
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 32
- From 20 Mar 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Diagnosis of other neurological disease (i.e., Parkinson's disease, multiple sclerosis, ...);
- Brainstem and cerebellar stroke.
Other
- Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe performance of UE tasks;
- Individuals currently enrolled in a UE rehabilitation program (i.e., OT, research study)
- Upper-extremity orthopedic injuries or severe pain resulting in movement limitations;
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Spaulding Rehabilitation Hospital Boston Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.