Chronic Stroke
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEMR-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.
Sponsors
MedRhythms, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of walking sessions during 12-week intervention period | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Test (6MWT) | From baseline to end of treatment at 12 weeks | To assess whether MR-001 improves walking endurance after 12 weeks of treatment |
| Patient Health Questionnaire-8 (PHQ-8) | 12 weeks | To assess whether MR-001 improves health-related quality of life in chronic stroke patients with gait deficit |
| The Barthel Index | 12 weeks | To assess whether MR-001 improves activities of daily living in chronic stroke patients with gait deficit |
| PROMIS Social Isolation Scale | 12 weeks | To assess whether MR-001 improves social isolation in patients with chronic stroke with gait deficit |
| Trail Making Tests A & B | 12 weeks | To assess whether MR-001 improves cognition and executive in patients with chronic stroke with gait deficit |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFrancois Bethoux, MD
The Cleveland Clinic
Outcome results
None listed