A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Subacute Stroke Survivors
Spaulding Rehabilitation Hospital
88 participants
Aug 8, 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 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).
Eligibility
Inclusion Criteria6
- 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 Criteria9
- 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.
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Interventions
Behavioral strategies will be incorporated into the Strokewear system to encourage feedback on behavior, goal setting, daily activity action planning (DAAP), and an empowerment/ self management model to foster planned hemiparetic UE use during daily activities in the home and community. 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 self- 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
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NCT06797154