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NCT05626894
Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
Conditions: Stroke, Stroke Sequelae, Hemiparesis;Poststroke/CVA
Sex: All
Ages: 18 Years – 85 Years
Phase: PHASE2
Enrollment: 32
Sponsor: Spaulding Rehabilitation Hospital
Location: United States
Summary
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
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.
Source: ClinicalTrials.gov (NCT05626894). StuddyBuddy aggregates publicly available trial information.