๐ฌIn plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 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) ;
* Owning a smartphone (iOS or Android) and being familiar and comfortable with and owning a tablet or smartphone
* SAFE score equal or greater than 5
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 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;
* 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;
* Not understanding spoken or written English;
* Contralateral motor deficits as assessed by clinical examination;
* Brainstem and cerebellar stroke.