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

Stroke Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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 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). 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05626894
Study type Interventional
Source Spaulding Rehabilitation Hospital
Contact Paolo Bonato, PhD
Phone 617-952-6319
Email pbonato@partners.org
Status Not yet recruiting
Phase Phase 2
Start date September 1, 2023
Completion date September 30, 2025
View Details
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