Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSpaulding Rehabilitation Hospital
About this trial
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).
Eligibility criteria
Qualifiers
Male or female, 18-85 years of age at the time of enrollment;
Anterior circulation ischemic stroke at least 6 months and up to 5 years 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 3 step command);
Disqualifiers
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 feedback on the app screen (as assessed with the star cancellation test);
Individuals with open wounds or recent fracture (less than 3 months) in the UE, fragile skin or active infection as evaluated by the study therapist;
Individuals currently enrolled in a UE rehabilitation program (i.e., OT, research study)
Trial design
Treatments tested in this trial
- StrokeWear Motor and Behavioral Intervention
- Usual Care
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
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
Source ClinicalTrials.gov