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Post-Stroke Walking Speed and Community Ambulation Conversion Study
Sponsor: MedRhythms, Inc.
Summary
The purpose of this randomized, controlled study is to collect performance data on the ability of an investigational device designed to digitally deliver Rhythmic Auditory Stimulation to improve walking speed in people who suffered a stroke greater than or equal to six (6) months in the past and who are limited in mobility outside the home. The primary outcomes will be the mean change in walking speed (meters per second) and mean percent change in walking speed as determined by a 10-meter Walk Test after five weeks of intervention and compared between groups.
Official title: Post-Stroke Walking Speed and Community Ambulation Conversion, A Pivotal Study
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
87
Start Date
2019-09-17
Completion Date
2022-02-11
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
MR-001
Participants will walk using the investigational device (foot sensors, mobile device with mobile app and headphones) for thirty (30) minutes at a time, 3 times a week for 5 weeks.
Active Walking
Participants will walk for thirty (30) minutes at a time, 3 times a week for 5 weeks. No mobile devices, music players or headphones will be allowed. They will wear foot sensors during their active walking sessions to measure gait biomechanics.
Locations (8)
Shirley Ryan AbilityLab
Chicago, Illinois, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Trustees of Boston University
Boston, Massachusetts, United States
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States
Kessler Foundation
West Orange, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health/Carolinas Rehabilitation
Charlotte, North Carolina, United States