Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation

Conditions
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Chronic Stroke

Intervention / Treatment
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* Device: MR-001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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). 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A: Restart Intervention<br>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<br>* 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.<br>|
| No Intervention: Cohort B: Continued Washout<br>Participants in Cohort B will continue their washout period for another 24 weeks. | |

What is the study measuring?
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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 |
| --- | --- | --- |
| 6 Minute Walk Test (6MWT) | To assess whether MR-001 improves walking endurance | 12 weeks | 
| 6 Minute Walk Test (6MWT) | To assess durability of response to MR-001 after 12 weeks of intervention | 12 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 | 24 weeks | 
| The Barthel Index | To assess whether MR-001 improves activities of daily living in chronic stroke patients with gait deficit | 24 weeks | 
| PROMIS Social Isolation Scale | To assess whether MR-001 improves social isolation in patients with chronic stroke with gait deficit | 24 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 |