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Completed
NCT04121754
Post-Stroke Walking Speed and Community Ambulation Conversion Study
Conditions: Chronic Stroke
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 87
Sponsor: MedRhythms, Inc.
Location: Shirley Ryan AbilityLab Chicago Illinois
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.
Eligibility Criteria
Inclusion Criteria:
1. 50 years of age and older
2. Equal to or greater than six months post-stroke
3. A comfortable walking speed greater than or equal to 0.5 m/s but less than 0.8 m/s, as determined by a 10-meter walk test, without assistive devices
4. Demonstrates some level of asymmetry in gait
5. Able and willing to consent, including to communicate with the treating clinician as needed during the study
6. Score ≤ 1 on question 1b and 0 on question 1c of the NIH Stroke Scale
7. Able to safely participate in 30-minute walking therapy sessions
Exclusion Criteria:
1. Currently enrolled in a study evaluating an investigational drug
2. Has already participated in this study
3. Unable or unwilling to provide informed consent
4. Unable to participate in 30-minute walking therapy sessions without assistive devices
5. Is a community ambulator (walking speed ≥ 0.8 m/s) without an assistive device
6. Has a known history of neurologic (excluding stroke) injury
7. Has had more than 2 falls in the previous month
8. Is enrolled in another walking rehabilitation intervention (e.g., physical therapy)
9. Has an external lower limb prosthetic ("artificial limb")
10. Has a hearing impairment that prevents interaction with the intervention system
11. Had orthopedic surgery in the last year
12. Has severe aphasia and/or a speech/language disorder
13. Has co-morbidities that prevent participation in exercise
14. Is part of a vulnerable population deemed inappropriate for the study by the site Principal Investigator
Note: Assistive devices include a cane, crutch, walker, or FES device; a lower limb brace is permitted.
Source: ClinicalTrials.gov (NCT04121754). StuddyBuddy aggregates publicly available trial information.