Post-Stroke Walking Speed and Community Ambulation Conversion Study

Completed · Not applicable

Conditions studied: Chronic Stroke

In brief

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 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.

Key facts

Study ID

NCT04121754

Run by

MedRhythms, Inc.

People needed

87

Starts

2019-09-17

Expected to finish

2022-02-11

Last updated by the study team

2023-09-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 50 years of age and older
• Equal to or greater than six months post-stroke
• A comfortable walking speed greater or equal to 0.5 meters per second (m/s), but less than 0.8m/s, as determined by a 10-meter walk test.
• Demonstrates some level of asymmetry in gait

You may not qualify if…

• Has a known history of neurologic (excluding stroke) injury
• Has had more than 2 falls in the previous month
• Is enrolled in another walking rehabilitation intervention (e.g., physical therapy)
• Has an external lower limb prosthetic ("artificial limb")
• Has a hearing impairment
• Had orthopedic surgery in the last year
• Has severe aphasia and/or a speech/language disorder
• Has co-morbidities that prevent participation in exercise

Where it is running

• 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

Full record on ClinicalTrials.gov

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