Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
Stroke, Stroke Sequelae, Hemiparesis;Poststroke/CVA
About this trial
This is an interventional treatment trial for Stroke focused on measuring StrokeWear, BioSensics, Behavioral intervention
Eligibility Criteria
Inclusion Criteria: 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); Being familiar and comfortable with the use of a tablet or smartphone. 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 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) 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 as assessed by the study therapist; Not understanding spoken or written English; Recent (less than 3 months) Botox injection in the UE or plan to undergo injections during the study timeline; Contralateral motor deficits as assessed by clinical examination; Brainstem and cerebellar stroke.
Sites / Locations
- Spaulding Rehabilitation Hospital Boston
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
StrokeWear Motor and Behavioral Intervention
Usual Care