Clinical trial NCT06051539: Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation
Official title: Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: MedRhythms, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-25
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of walking sessions during 12-week intervention period
timeFrame: 12 weeks
Secondary outcomes:
measure: 6 Minute Walk Test (6MWT)
timeFrame: From baseline to end of treatment at 12 weeks
measure: 6 Minute Walk Test (6MWT)
timeFrame: At 16 and 24 weeks
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: 12 weeks
measure: The Barthel Index
timeFrame: 12 weeks
measure: PROMIS Social Isolation Scale
timeFrame: 12 weeks
measure: Trail Making Tests A & B
timeFrame: 12 weeks
Other outcomes:
measure: 6 Minute Walk Test (6MWT)
timeFrame: At 36 weeks
measure: Timed Up and Go (TUG)
timeFrame: 12 weeks
measure: Timed Up and Go (TUG)
timeFrame: At 36 weeks
measure: All-cause HCRU
timeFrame: Baseline to 52 weeks
measure: All-cause hospitalizations and emergency department visits
timeFrame: Baseline to 52 weeks
Locations:
city: Portland
country: United States
facility: Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL
state: Maine
Study officials:
affiliation: The Cleveland Clinic
name: Francois Bethoux, MD
role: PRINCIPAL_INVESTIGATOR
References: