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

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Other
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Male or female, 18-85 years of age at the time of enrollment;

• Anterior circulation ischemic stroke at least 6 months and up to 5 years 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 3 step command);

• Being familiar and comfortable with the use of a tablet or smartphone.

Locations
United States
Massachusetts
Spaulding Rehabilitation Hospital Boston
RECRUITING
Boston
Contact Information
Primary
Paolo Bonato, PhD
pbonato@partners.org
617-952-6319
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 32
Treatments
Experimental: StrokeWear Motor and Behavioral Intervention
Stroke survivors randomized to this group will receive standard occupational and physical therapy in addition to a behavioral intervention aimed to encourage stroke survivors to use their affect arm during the performance of activities of daily living.
Sham_comparator: Usual Care
Stroke survivors randomized to this group will receive standard occupational and physical therapy.
Related Therapeutic Areas
Sponsors
Leads: Spaulding Rehabilitation Hospital
Collaborators: BioSensics, MGH Institute of Health Professions, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov