NCT06051539Completed
Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
The purpose of this trial is to assess engagement, efficacy, durability, and impact on health care resource utilization of MR-001 in persons with chronic stroke who have a gait deficit after in-home/community use.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 234 (actual)
- First submitted
- 13 Sept 2023
- Start date
- 10 Oct 2023
- Primary completion date
- 22 Nov 2024
- Lead sponsor
- MedRhythms, Inc.
- Diseases
- Stroke
- NCT number
- NCT06051539
What you commit to
- Study type: Interventional
- Participants enrolled: 234
- From 10 Oct 2023 to the primary completion date, 22 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- More than 2 falls in the previous month
- Treatment with a gait-based investigational intervention within the last 3 months.
Other illness
- Hearing impairment with or without the use of hearing aids such that the participant cannot hear the rhythmic stimulation of the music
- Significant comorbid medical or neurological conditions that could impact gait or prevent safe participation as determined by the Investigator. For example: condition that prevents participation in exercise, e.g., Parkinson's disease, cerebral palsy, multiple sclerosis, myasthenia gravis, muscular dystrophy, or spinal cord injury. Note: major surgery within the last 3 months is exclusionary.
Other
- Pain that impairs walking ability
- Unable to safely participate in walking sessions as determined by investigator
- Requires more than one rest (seated or not) during the 6MWT
- People who are pregnant or become pregnant (due to expected gait pattern changes).
- Lower limb prosthetic
- Non-reciprocal gait pattern. Note: Note: a non-reciprocal gait pattern is defined as a 3-point step pattern. Participants must have a 2-point step pattern to qualify. Asymmetry seen in gait is acceptable.
- Unable or unwilling to provide informed consent to participate
Who the study is looking for
- Equal to or greater than 6 months post-stroke with gait impairment
- Age \>/= 18 - 85 years of age, inclusive
- Understand and speak English
- Must be able to ambulate without assistance from another person. Note: assistive devices are allowed. If a participant uses an assistive device at the time of enrollment, the device must be used for all walking sessions.
- Willing to travel to a Velocity location to complete in-person gait assessments
- Able to walk at a speed greater than or equal to 0.4 m/s as derived as an average of speed per minute from the 6MWT. Note: if a participant intends to use an assistive device throughout the intervention period, the assistive device must be used during the gait assessment.
- Must have claims data available and consent to sharing.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.