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RECRUITINGNA

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

NCT06797154•Spaulding Rehabilitation Hospital

View on ClinicalTrials.gov

Summary

Detailed Description

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). Study participants will be asked to take part in 4 evaluation study visits: one screening and enrollment visit, and three evaluation visits (at baseline, at 3 months and at 6 months - at the intervention completion). Subject upper-extremity motor function will be assessed across domains of the International Classification of Functioning, Disability and Health (ICF) model. Groups will be stratified by baseline motor impairment and stroke chronicity. Subjects randomized to the intervention group will take part of weekly coaching sessions during the first month, bi-weekly sessions during the months 2 and 3, and monthly sessions during months 4-6. These sessions will be held in-person or remotely, based on the study participant preference. Subjects randomized to the control group will take part of monthly visits, held in-person or remotely (based on study participant preference), to re-evaluate the home-exercise plan and prescribe an update list of exercises for the following month.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

August 8, 2025

Primary Completion Date

June 30, 2026

Completion Date

August 31, 2026

Last Updated

November 28, 2025

Enrollment

ESTIMATED participants

Conditions

StrokeStroke SequelaeHemiparesis;Poststroke/CVA

Interventions

StrokeWear Behavioral Intervention

BEHAVIORAL

Usual Care + Sham

OTHER

Contacts

Paolo Bonato, PhD

CONTACT

617-952-6319 pbonato@partners.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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