An interventional study of MR-001 in Chronic Stroke, sponsored by MedRhythms, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by MedRhythms, Inc. · Not applicable, Interventional, and Other
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.
MedRhythms, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants in Cohort B will continue their washout period for another 24 weeks.
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.
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.
Time frame: 12 weeks
6 Minute Walk Test (6MWT)
To assess whether MR-001 improves walking endurance after 12 weeks of treatment
Time frame: 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
Time frame: 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
Time frame: 12 weeks
The Barthel Index
To assess whether MR-001 improves activities of daily living in chronic stroke patients with gait deficit
Time frame: 12 weeks
PROMIS Social Isolation Scale
To assess whether MR-001 improves social isolation in patients with chronic stroke with gait deficit
Time frame: 12 weeks
Trail Making Tests A & B
To assess whether MR-001 improves cognition and executive in patients with chronic stroke with gait deficit
Time frame: 12 weeks
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
Time frame: At 36 weeks
Timed Up and Go (TUG)
To assess change in mobility after 12 weeks of intervention
Time frame: 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
Time frame: At 36 weeks
All-cause HCRU
To assess change in all-cause healthcare resource utilization
Time frame: Baseline to 52 weeks
All-cause hospitalizations and emergency department visits
To assess change in all-cause hospitalizations and emergency department visits
Time frame: Baseline to 52 weeks
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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MedRhythms, Inc.