Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Chronic Stroke Survivors
Spaulding Rehabilitation Hospital
32 participants
Mar 20, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria11
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The intervention will consist of 1) the use of StrokeWear for goal directed movements (GDM) feedback and goal setting, 2) use of daily activity action planning (DAAP) to foster planned hemiparetic UE use during daily activities in the home and community, and 3) patient empowerment. Patient empowerment in this study will occur over 6-months as patients gain the ability to use the StrokeWear technology independently and develop skills to manage their GDM and DAAP.
The intervention will consist in a sham version of the StrokeWear system and usual clinical care under the direction of a clinician. The sham version of the StrokeWear system will include sensing and recording technology to detect GDMs. However, study participants will not receive feedback from the system regarding the GDM counts.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05626894