A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors

Launched by SPAULDING REHABILITATION HOSPITAL · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new wrist wearable device called the StrokeWear system, which aims to help people who have had a stroke use their affected arm more effectively. The trial will involve two groups: one group will use the StrokeWear device along with specific exercises at home to improve their upper arm movement, while the other group will continue their usual care, which includes a basic home exercise plan. The study will last for six months and will look at how well the StrokeWear system improves arm use in participants who are recovering from a stroke.

To participate in this trial, individuals must be between 18 and 85 years old and have experienced a specific type of stroke within the last month to six months. They should have some movement ability in their affected arm but still have difficulty using it. Participants need to be able to understand the study instructions and have access to a smartphone or tablet. If you meet these criteria, you may be eligible for the study. During the trial, participants can expect regular check-ins and support as they work on improving their arm function with the help of the StrokeWear system. It’s important to note that certain conditions, like severe spasticity or other neurological diseases, would prevent someone from joining the study.

Gender

ALL

Eligibility criteria

• 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.