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ACTIVE NOT RECRUITING

NCT06051539

Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation

Sponsor: MedRhythms, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

234

Start Date

2023-10-10

Completion Date

2025-12

Last Updated

2025-09-10

Healthy Volunteers

Conditions

Chronic Stroke

Interventions

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.

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

Locations (1)

Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL

Portland, Maine, United States