Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedRhythms, Inc.
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 participants will be assigned by chance to one of the two study groups. Participants will not be able to switch groups once they are assigned. The investigational device includes a mobile device app and sensors that are attached to shoes. Headphones and a mobile device are also required to be used and will be provided in this study.
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Post-Stroke Walking Speed and Community Ambulation Conversion Study
