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).
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) ;
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;
Spaulding Rehabilitation Hospital
Lead sponsor
BioSensics
Collaborator
MGH Institute of Health Professions
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator