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RECRUITING
NCT05626894
PHASE2

Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic 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 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).

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-03-20

Completion Date

2026-09-30

Last Updated

2025-11-28

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

StrokeWear Motor and Behavioral Intervention

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.

OTHER

Usual Care

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

Boston, Massachusetts, United States