Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation

NCT06051539 | Completed FDA Device

• 1 other identifier: PS300
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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/community use.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (1)

• Number of walking sessions during 12-week intervention period

  The purpose 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. Engagement will be measured as number of walking sessions observed across the 12 week intervention period.

  12 weeks

Secondary Outcomes (6)

• 6 Minute Walk Test (6MWT)

  From baseline to end of treatment at 12 weeks

• 6 Minute Walk Test (6MWT)

  At 16 and 24 weeks

• Patient Health Questionnaire-8 (PHQ-8)

  12 weeks

• The Barthel Index

  12 weeks

• PROMIS Social Isolation Scale

  12 weeks

Other Outcomes (5)

• 6 Minute Walk Test (6MWT)

  At 36 weeks

• Timed Up and Go (TUG)

  12 weeks

• Timed Up and Go (TUG)

  At 36 weeks

Study Arms (2)

Cohort A: Restart Intervention

EXPERIMENTAL

Participants in Cohort A will perform active walking for 30 minutes at a time with MR-001, at least 3 times a week, for 12 weeks in their home/community environment.

Device: MR-001

Cohort B: Continued Washout

NO INTERVENTION

Participants in Cohort B will continue their washout period for another 24 weeks.

Interventions

MR-001 DEVICE

MR-001 is an autonomous neurorehabilitation system based on the principles of Rhythmic Auditory Stimulation intended to improve walking and ambulation in adult chronic stroke patients. MR-001 is intended to be a prescription use only device for use at home/community. The user operates the MR-001 System 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 touchscreen device preloaded solely with a proprietary software application, a headset, and charging equipment. The electronic components are powered by lithium-ion rechargeable batteries. Participants are asked to walk with the device for 3 times per week for 12 weeks. Each walking session is 30 minutes in length.

Cohort A: Restart Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• MedRhythms, Inc.: lead

Study Sites (1)

Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL

Portland, Maine, 04101, United States

Location

Related Publications (1)

• Taylor SR, Awad LN, Carlowicz CA, Maricich YA, Finklestein SP, Riley EH, Harris BA, Pohlig RT, Bethoux FA. Outcomes and Health Economics of Stroke using Rhythmic Auditory Stimulation (OrcHESTRAS): a protocol for a pragmatic, decentralized, longitudinal, multi-phase, withdrawal with randomized re-treatment trial of MR-001 in chronic stroke. Trials. 2026 Jan 8;27(1):108. doi: 10.1186/s13063-025-09415-3.

  PMID: 41501870 DERIVED

Study Officials

• Francois Bethoux, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will follow a withdrawal with randomized re-treatment design. The study will consist of two steps. In Step 1, all participants will receive the MR-001 intervention for 12 weeks, followed by a 12-week washout period. At Step 2, participants will be randomized to receive either another 12 weeks of intervention followed by another 12-week washout or continue their first washout for an additional 24 weeks.

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 25, 2023
• Study Start: October 10, 2023
• Primary Completion: November 22, 2024
• Study Completion: October 1, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)