Status:
ACTIVE_NOT_RECRUITING
Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation
Lead Sponsor:
MedRhythms, Inc.
Conditions:
Chronic Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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/c...
Detailed Description
This is a decentralized clinical trial designed to assess clinical outcomes and resulting healthcare resource utilization (HCRU) of MedRhythms' MR-001 device used by patients with chronic stroke in th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Hearing impairment with or without the use of hearing aids such that the participant cannot hear the rhythmic stimulation of the music
- 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
- 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.
- People who are pregnant or become pregnant (due to expected gait pattern changes).
- Lower limb prosthetic
- More than 2 falls in the previous month
- 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.
- Treatment with a gait-based investigational intervention within the last 3 months.
- Unable or unwilling to provide informed consent to participate
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT06051539
Start Date
October 10 2023
End Date
December 1 2025
Last Update
September 10 2025
Active Locations (1)
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1
Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL
Portland, Maine, United States, 04101