Actively Recruiting
Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
Led by Spaulding Rehabilitation Hospital · Updated on 2025-11-28
32
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
Sponsors
S
Spaulding Rehabilitation Hospital
Lead Sponsor
B
BioSensics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18-85 years of age at the time of enrollment
- Anterior circulation ischemic stroke occurred at least 6 months and up to 5 years before enrollment
- Unilateral upper extremity weakness with initial Fugl-Meyer Assessment upper limb score between 20 and 45
- Intact cognitive ability with MMSE score above 23 and able to follow a 3-step command
- Familiar and comfortable using a tablet or smartphone
You will not qualify if you...
- Severe spasticity with Modified Ashworth scale score of 3 or higher preventing safe arm tasks
- Visual impairments or hemispatial neglect that affect ability to see app feedback
- Open wounds, recent fractures (under 3 months), fragile skin, or active infection in the upper extremity
- Currently enrolled in upper extremity rehabilitation programs
- Upper-extremity orthopedic injuries or severe pain limiting movement
- Diagnosis of other neurological diseases such as Parkinson's disease or multiple sclerosis
- Severe proprioceptive deficits impairing vibration feedback processing
- Not understanding spoken or written English
- Recent (under 3 months) or planned Botox injections in the upper extremity during the study
- Contralateral motor deficits
- Brainstem or cerebellar stroke
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Spaulding Rehabilitation Hospital Boston
Boston, Massachusetts, United States, 02129
Actively Recruiting
Research Team
P
Paolo Bonato, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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