Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors

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).

Conditions

• Stroke
• Stroke Sequelae
• Hemiparesis;Poststroke/CVA

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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital

  lead OTHER

• BioSensics

  collaborator INDUSTRY

• MGH Institute of Health Professions

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

Principal Investigators

• Paolo Bonato, PhD · Spaulding Rehabilitation Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-20

Primary Completion

2026-06-30

Completion

2026-09-30

FDA Device

Yes

Countries

• United States

Study Locations