Stroke Clinical Trial
Official title:
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Chronic Stroke Survivors
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).
Status | Not yet recruiting |
Enrollment | 32 |
Est. completion date | September 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Spaulding Rehabilitation Hospital Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Spaulding Rehabilitation Hospital | BioSensics, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), MGH Institute of Health Professions |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Canadian Occupational Performance Measure (COPM) | Semi-structured interview to assess outcomes in the areas of self-care, productivity and leisure. Score from 0 (worst) to 10 (best). | Change from baseline Canadian Occupational Performance Measure (COPM) score at 6 months | |
Other | Number of times the activity goals are reached | Number of times the activity goals set are reached over the study duration | At 6 months | |
Primary | Change in Motor Activity Log-Amount of Use | Self-reported measure of upper-extremity performance. Score from 0 (worst) to 5 (best) | Change from baseline Motor Activity Log-Amount of Use score at 6 months | |
Primary | Change in Fugl-Meyer Upper-Extremity | Observed measure of upper-extremity motor impairment following a stroke. Score from 0 (worst) to 66 (best) | Change from baseline Fugl-Meyer Upper-Extremity score at 6 months | |
Primary | Change in Upper-Extremity Activity Counts | Activity of the hemiparetic upper-extremity in the home setting as measured with wrist-worn accelerometers | Change from baseline Upper-Extremity Activity Counts score at 6 months | |
Secondary | Change in Motor Activity Log-Quality of Use | Self-reported measure of upper-extremity quality of use. Score from 0 (worst) to 5 (best) | Change from baseline Motor Activity Log-Quality of Use score at 6 months | |
Secondary | Change in Wolf-Motor Function Test - Time subscale | Observed (timed) measure of upper-extremity function. Time from 0 to 120 seconds (maximum time allowed to attempt to perform a motor task) | Change from baseline Wolf-Motor Function Test - Time subscale score at 6 months | |
Secondary | Change in Wolf-Motor Function Test - Functional ability subscale | Measure of upper-extremity quality of movement based on visual observation. Score from 0 (worst) to 5 (best) | Change from baseline Wolf-Motor Function Test - Functional ability subscale score at 6 months | |
Secondary | Change in Stroke Impact Scale (SIS) | Self-reported measure of quality of life after a stroke. Score from 0 (best) to 42 (worst) | Change from baseline Stroke Impact Scale (SIS) score at 6 months | |
Secondary | Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale | Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best). | Change from baseline Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale score at 6 months | |
Secondary | Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Self-management subscale | Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best). | Change from baseline Self-Efficacy Questionnaire (SSEQ) - Self-management subscale score at 6 months |
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