Status:
RECRUITING
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
Lead Sponsor:
Spaulding Rehabilitation Hospital
Collaborating Sponsors:
BioSensics
MGH Institute of Health Professions
Conditions:
Stroke
Stroke Sequelae
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 subacute stroke survivors. The Inter...
Detailed Description
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 subacute stroke survivors. The Inter...
Eligibility 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.
Key Trial Info
Start Date :
August 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06797154
Start Date
August 8 2025
End Date
August 31 2026
Last Update
November 28 2025
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129