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COMPLETED
NCT04121754
NA

Post-Stroke Walking Speed and Community Ambulation Conversion Study

Sponsor: MedRhythms, Inc.

View on ClinicalTrials.gov

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

DEVICE

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.

OTHER

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