Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation

Last updated: September 3, 2025
Sponsor: MedRhythms, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

MR-001

Clinical Study ID

NCT06051539
PS300
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Equal to or greater than 6 months post-stroke with gait impairment

  2. Age >/= 18 - 85 years of age, inclusive

  3. Understand and speak English

  4. Must be able to ambulate without assistance from another person. Note: assistivedevices are allowed. If a participant uses an assistive device at the time ofenrollment, the device must be used for all walking sessions.

  5. Willing to travel to a Velocity location to complete in-person gait assessments

  6. Able to walk at a speed greater than or equal to 0.4 m/s as derived as an average ofspeed per minute from the 6MWT. Note: if a participant intends to use an assistivedevice throughout the intervention period, the assistive device must be used duringthe gait assessment.

  7. Must have claims data available and consent to sharing.

Exclusion

Exclusion Criteria:

  1. Hearing impairment with or without the use of hearing aids such that the participantcannot hear the rhythmic stimulation of the music

  2. Pain that impairs walking ability

  3. Unable to safely participate in walking sessions as determined by investigator

  4. Requires more than one rest (seated or not) during the 6MWT

  5. Significant comorbid medical or neurological conditions that could impact gait orprevent safe participation as determined by the Investigator. For example: conditionthat 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.

  6. People who are pregnant or become pregnant (due to expected gait pattern changes).

  7. Lower limb prosthetic

  8. More than 2 falls in the previous month

  9. Non-reciprocal gait pattern. Note: Note: a non-reciprocal gait pattern is defined asa 3-point step pattern. Participants must have a 2-point step pattern to qualify.Asymmetry seen in gait is acceptable.

  10. Treatment with a gait-based investigational intervention within the last 3 months.

  11. Unable or unwilling to provide informed consent to participate

Study Design

Total Participants: 234
Treatment Group(s): 1
Primary Treatment: MR-001
Phase:
Study Start date:
October 10, 2023
Estimated Completion Date:
December 31, 2025

Study 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 the home setting.

MR-001 is an autonomous neurorehabilitation system based on the principles of Rhythmic Auditory Stimulation intended to improve walking in adult chronic stroke patients. MR-001 is a prescription medical device intended for use at home. The user operates the device autonomously and the therapy progresses automatically once a user engages in a session.

The MR-001 system consists of two foot sensors that measure walking, a locked touchscreen device preloaded with a proprietary software application, a headset, and charging equipment. The electronic components are powered by lithium-ion rechargeable batteries.

The primary objective of this study is to assess engagement with MR-001 walking therapy in chronic stroke patients with a gait deficit in a real world setting. The primary endpoint will be measured by session completion over the 12 week intervention period. Secondary endpoints include assessing effect on walking endurance, durability of response, and reintroduction of the intervention, as well as effect on healthcare resource utilization.

Connect with a study center

  • Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL

    Portland, Maine 04101
    United States

    Site Not Available

  • Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL

    Portland 4975802, Maine 4971068 04101
    United States

    Site Not Available

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