Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation (OrcHESTRAS)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Stroke
• Intervention / Treatment: Device: MR-001

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 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.

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maine
    • Portland, Maine, United States, 04101
      • Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

1. Hearing impairment with or without the use of hearing aids such that the participant cannot 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 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.
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 as a 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: Restart Intervention; 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; 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.
No Intervention: Cohort B: Continued Washout; Participants in Cohort B will continue their washout period for another 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trail Making Tests A & B	To assess whether MR-001 improves cognition and executive in patients with chronic stroke with gait deficit	12 weeks
6 Minute Walk Test (6MWT)	To assess whether MR-001 improves walking endurance after 12 weeks of treatment	From baseline to end of treatment at 12 weeks
6 Minute Walk Test (6MWT)	To assess durability of walking endurance response to MR-001 after 12 weeks of intervention	At 16 and 24 weeks
Patient Health Questionnaire-8 (PHQ-8)	To assess whether MR-001 improves health-related quality of life in chronic stroke patients with gait deficit	12 weeks
The Barthel Index	To assess whether MR-001 improves activities of daily living in chronic stroke patients with gait deficit	12 weeks
PROMIS Social Isolation Scale	To assess whether MR-001 improves social isolation in patients with chronic stroke with gait deficit	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up and Go (TUG)	To assess change in mobility after 12 weeks of intervention	12 weeks
6 Minute Walk Test (6MWT)	To assess change in walking endurance of persons who are re-introduced to a second round of treatment with the intervention	At 36 weeks
Timed Up and Go (TUG)	To assess change in mobility of persons who are re-introduced to a second round of treatment with the intervention	At 36 weeks
All-cause HCRU	To assess change in all-cause healthcare resource utilization	Baseline to 52 weeks
All-cause hospitalizations and emergency department visits	To assess change in all-cause hospitalizations and emergency department visits	Baseline to 52 weeks

Collaborators and Investigators

• Sponsor: MedRhythms, Inc.
• Investigators: Principal Investigator: Francois Bethoux, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Actual): November 22, 2024
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: PS300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No