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

MedRhythms

Status: Active, not recruiting

Conditions: Chronic Stroke

Treatments: Device: MR-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT06051539

PS300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

Cohort A: Restart Intervention

Experimental group

Description:

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.

Treatment:

Device: MR-001

Cohort B: Continued Washout

No Intervention group

Description:

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