CompletedNot Applicable

Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation

United States234 participantsStarted 2023-10-10

Plain-language 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/community use.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Number of walking sessions during 12-week intervention period

Timeframe: 12 weeks

Trial details

NCT IDNCT06051539

SponsorMedRhythms, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-22

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