Actively Recruiting
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Subacute Stroke Survivors
Led by Spaulding Rehabilitation Hospital · Updated on 2025-11-28
88
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
S
Spaulding Rehabilitation Hospital
Lead Sponsor
B
BioSensics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the StrokeWear system to see how it affects clinical outcomes in people who have recently experienced a stroke. This study is a two-arm randomized clinical trial focusing on subacute stroke survivors with hemiparetic upper extremity weakness. The goal is to understand whether using the StrokeWear system combined with a motor and behavioral home intervention improves arm use compared to usual care involving a home exercise plan. Participants in the intervention group will use the StrokeWear system along with behavioral strategies designed to encourage arm use through feedback, goal setting, and daily activity planning over 6 months. They will receive weekly coaching sessions in the first month, bi-weekly in months two and three, and monthly sessions in months four to six, which can be in-person or remote. The control group will receive usual care, including standard rehabilitation and a home exercise plan, with monthly visits to update their exercises. Study participants will attend four evaluation visits: screening and enrollment, baseline, 3 months, and at the study's 6-month completion. Researchers will assess upper-extremity motor function using multiple scales such as the Motor Activity Log and Fugl-Meyer Assessment. Additional tests include the Wolf Motor Function Test and Stroke Impact Scale. Monitoring includes assessing changes in arm use, motor function, and self-efficacy. The total participation lasts for six months, with assessments at regular intervals to track progress and outcomes.
CONDITIONS
Brief 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 between 1 and 6 months prior to enrollment
- Unilateral upper extremity hemiparesis with Fugl-Meyer Assessment upper limb subtest score between 20 and 45
- Intact cognitive function with MMSE score above 23 and ability to follow 3-step commands
- Own and be comfortable using a smartphone (iOS or Android) or tablet
- SAFE score of 5 or greater
You will not qualify if you...
- Severe spasticity with a Modified Ashworth scale score of 3 or more preventing safe arm movement
- Visual impairments or hemispatial neglect affecting ability to see app feedback
- Open wounds, recent fractures (less than 3 months), fragile skin, or active infection in the upper extremity
- Upper-extremity orthopedic injuries or severe pain limiting movement
- Diagnosis of other neurological diseases (e.g., Parkinson's disease, multiple sclerosis)
- Severe proprioceptive deficits impairing vibration feedback processing
- Inability to understand spoken or written English
- Contralateral motor deficits
- Brainstem or cerebellar stroke
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or remote)
Duration - 6 months
Participants receive either the StrokeWear behavioral intervention combined with motor and behavioral home therapy or usual care with a home-exercise plan. The intervention group has coaching sessions that decrease in frequency over 6 months, while the control group has monthly visits to update their exercise plan. Sessions may be in-person or remote based on participant preference.
4 evaluation visits (baseline, 3 months, 6 months) plus weekly to monthly coaching or usual care visits depending on group assignment
Trial Site Locations
Total: 1 location
1
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129
Actively Recruiting
Research Team
P
Paolo Bonato, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here