AzTrials
AzTrials

Chronic StrokeOrcHESTRASNCT06051539

Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation

A study testing MR-001 in people with Chronic Stroke, run by MedRhythms, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Chronic Stroke
What is being tested?
MR-001
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
1 siteUnited States
Study dates
10 Oct 2023to 1 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL

    Portland, Maine, 04101

Other trials in United States

About this study

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.

Read the 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.

Conditions
Chronic Stroke
Being tested
MR-001

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MR-001Device

    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.

Study groups in NCT06051539
Study groupRoleWhat they receive
Cohort A: Restart InterventionExperimentalParticipants 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.
Receives: Device: MR-001
Cohort B: Continued WashoutNo interventionParticipants in Cohort B will continue their washout period for another 24 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (6)

  1. 6 Minute Walk Test (6MWT)

    To assess whether MR-001 improves walking endurance after 12 weeks of treatment

    Measured: From baseline to end of treatment at 12 weeks

  2. 6 Minute Walk Test (6MWT)

    To assess durability of walking endurance response to MR-001 after 12 weeks of intervention

    Measured: At 16 and 24 weeks

  3. Patient Health Questionnaire-8 (PHQ-8)

    To assess whether MR-001 improves health-related quality of life in chronic stroke patients with gait deficit

    Measured: 12 weeks

  4. The Barthel Index

    To assess whether MR-001 improves activities of daily living in chronic stroke patients with gait deficit

    Measured: 12 weeks

  5. PROMIS Social Isolation Scale

    To assess whether MR-001 improves social isolation in patients with chronic stroke with gait deficit

    Measured: 12 weeks

  6. Trail Making Tests A & B

    To assess whether MR-001 improves cognition and executive in patients with chronic stroke with gait deficit

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start10 Oct 2023
  3. Primary completion22 Nov 2024
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06051539
Sponsor's protocol ID
PS300
Acronym
OrcHESTRAS
Status last verified
Apr 2026
First submitted
13 Sep 2023
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 41501870

Questions about this trial

What is this clinical trial studying?

A study testing MR-001 in people with Chronic Stroke, run by MedRhythms, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of walking sessions during 12-week intervention period (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06051539, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in