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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Cohort B: Continued Washout | No Intervention | Participants in Cohort B will continue their washout period for another 24 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 after 12 weeks of intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francois Bethoux, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL | Portland | Maine | 04101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41501870 | Derived | 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. |
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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.
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| 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 |
| Trail Making Tests A & B | To assess whether MR-001 improves cognition and executive in patients with chronic stroke with gait deficit | 12 weeks |
| 12 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 |