Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors

Launched by SPAULDING REHABILITATION HOSPITAL · Nov 15, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called the StrokeWear system, designed to help people who have had a stroke use their weaker arm more often in daily life. The study will last for six months and will compare two groups of participants. One group will use the StrokeWear system along with a special home exercise program, while the other group will follow their usual care routine, which includes a basic home exercise plan. The trial aims to see if using the StrokeWear system can improve arm function and overall quality of life for those who have experienced a stroke.

To participate, you need to be between 18 and 85 years old and have had a stroke affecting one arm at least six months ago. You should also be able to understand instructions and be comfortable using a tablet or smartphone. However, some people may not be eligible, such as those with severe stiffness in their arm, significant vision problems, or certain other health issues. If you join the study, you'll be monitored and supported as you work with the StrokeWear system or your regular care plan over the six-month period. This could be a great opportunity to explore new ways to improve arm movement and daily functioning after a stroke.

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 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.