A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Subacute Stroke Survivors
Who can join
Ages 18 to 85 · All sexes
Full 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.
About the study
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).
What is being tested
- StrokeWear Behavioral Intervention (behavioral)
- Usual Care + Sham (other)
Sponsor: Spaulding Rehabilitation Hospital · Participants: 88 · Started: Aug 8, 2025
Contact the study team
- Paolo Bonato, PhD · Phone: 617-952-6319
Official record on ClinicalTrials.gov — NCT06797154
Locations in the U.S.
| Massachusetts | Spaulding Rehabilitation Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.