Actively Recruiting
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
Led by Spaulding Rehabilitation Hospital · Updated on 2025-11-28
88
Participants Needed
1
Research Sites
55 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 subacute 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
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute 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 at least 1 month and no more than 6 months prior to study enrollment
- Unilateral upper extremity hemiparesis with Fugl-Meyer Assessment upper limb subtest scores between 20 and 45
- Intact cognitive function with MMSE score above 23 and ability to follow a 3-step command
- Own a smartphone (iOS or Android) and be comfortable using a tablet or smartphone
- SAFE score equal to or greater than 5
You will not qualify if you...
- Severe spasticity with a Modified Ashworth scale score of 3 or more that prevents safe upper extremity tasks
- Visual impairments or hemispatial neglect affecting ability to see app feedback
- Open wounds, recent fractures less than 3 months old, fragile skin, or active infection in the upper extremity
- Orthopedic injuries or severe pain in upper extremity causing movement limitations
- Diagnosis of other neurological diseases such as Parkinson's disease or multiple sclerosis
- Severe proprioceptive deficits impairing vibration feedback processing
- Inability to understand spoken or written English
- Contralateral motor deficits on clinical exam
- Brainstem or cerebellar stroke
AI-Screening
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Trial Site Locations
Total: 1 location
1
Spaulding Rehabilitation Hospital
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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