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RECRUITING
NCT06797154
NA

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

Sponsor: Spaulding Rehabilitation Hospital

View on ClinicalTrials.gov

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).

Official title: A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Subacute Stroke Survivors

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2025-08-08

Completion Date

2026-08-31

Last Updated

2025-11-28

Healthy Volunteers

No

Interventions

BEHAVIORAL

StrokeWear Behavioral Intervention

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.

OTHER

Usual Care + Sham

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)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States