Status:
COMPLETED
Post-Stroke Walking Speed and Community Ambulation Conversion Study
Lead Sponsor:
MedRhythms, Inc.
Conditions:
Chronic Stroke
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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 walki...
Detailed Description
Study participants who take part in this research study will participate in a screening visit, fifteen (15) intervention visits over approximately five weeks and a final closing visit. Study participa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2022
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04121754
Start Date
September 17 2019
End Date
February 11 2022
Last Update
September 6 2023
Active Locations (8)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
2
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21218
3
Trustees of Boston University
Boston, Massachusetts, United States, 02215
4
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129