Back to resultsOutcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation (OrcHESTRAS)
Primary Purpose
Chronic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR-001
Sponsored by
About this trial
This is an interventional other trial for Chronic Stroke
Eligibility Criteria
Inclusion Criteria: Equal to or greater than 6 months post-stroke with gait impairment Age >/= 18 - 85 years of age, inclusive Understand and speak English 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. Willing to travel to a Velocity location to complete in-person gait assessments 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. Must have claims data available and consent to sharing. Exclusion Criteria: Hearing impairment with or without the use of hearing aids such that the participant cannot hear the rhythmic stimulation of the music Pain that impairs walking ability Unable to safely participate in walking sessions as determined by investigator Requires more than one rest (seated or not) during the 6MWT 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. People who are pregnant or become pregnant (due to expected gait pattern changes). Lower limb prosthetic More than 2 falls in the previous month 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. Treatment with a gait-based investigational intervention within the last 3 months. Unable or unwilling to provide informed consent to participate
Sites / Locations
- Curavit Clinical Research - DECENTRALIZED CLINICAL TRIALRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cohort A: Restart Intervention
Cohort B: Continued Washout
Arm 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.
Participants in Cohort B will continue their washout period for another 24 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
6 Minute Walk Test (6MWT)
To assess whether MR-001 improves walking endurance
6 Minute Walk Test (6MWT)
To assess durability of response to MR-001 after 12 weeks of intervention
Patient Health Questionnaire-8 (PHQ-8)
To assess whether MR-001 improves health-related quality of life in chronic stroke patients with gait deficit
The Barthel Index
To assess whether MR-001 improves activities of daily living in chronic stroke patients with gait deficit
PROMIS Social Isolation Scale
To assess whether MR-001 improves social isolation in patients with chronic stroke with gait deficit
Trail Making Tests A & B
To assess whether MR-001 improves cognition and executive in patients with chronic stroke with gait deficit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06051539
Brief Title
Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation
Acronym
OrcHESTRAS
Official Title
Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedRhythms, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A: Restart Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Cohort B: Continued Washout
Arm Type
No Intervention
Arm Description
Participants in Cohort B will continue their washout period for another 24 weeks.
Intervention Type
Device
Intervention Name(s)
MR-001
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of walking sessions during 12-week intervention period
Description
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
Secondary Outcome Measure Information:
Title
6 Minute Walk Test (6MWT)
Description
To assess whether MR-001 improves walking endurance
Time Frame
12 weeks
Title
6 Minute Walk Test (6MWT)
Description
To assess durability of response to MR-001 after 12 weeks of intervention
Time Frame
12 weeks
Title
Patient Health Questionnaire-8 (PHQ-8)
Description
To assess whether MR-001 improves health-related quality of life in chronic stroke patients with gait deficit
Time Frame
24 weeks
Title
The Barthel Index
Description
To assess whether MR-001 improves activities of daily living in chronic stroke patients with gait deficit
Time Frame
24 weeks
Title
PROMIS Social Isolation Scale
Description
To assess whether MR-001 improves social isolation in patients with chronic stroke with gait deficit
Time Frame
24 weeks
Title
Trail Making Tests A & B
Description
To assess whether MR-001 improves cognition and executive in patients with chronic stroke with gait deficit
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
6 Minute Walk Test (6MWT)
Description
To assess change in walking endurance of persons who are re-introduced to a second round of treatment with the intervention
Time Frame
12 weeks
Title
Timed Up and Go (TUG)
Description
To assess change in mobility after 12 weeks of intervention
Time Frame
12 weeks
Title
Timed Up and Go (TUG)
Description
To assess change in mobility of persons who are re-introduced to a second round of treatment with the intervention
Time Frame
12 weeks
Title
All-cause HCRU
Description
To assess change in all-cause healthcare resource utilization
Time Frame
52 weeks
Title
All-cause hospitalizations and emergency department visits
Description
To assess change in all-cause hospitalizations and emergency department visits
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Equal to or greater than 6 months post-stroke with gait impairment
Age >/= 18 - 85 years of age, inclusive
Understand and speak English
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.
Willing to travel to a Velocity location to complete in-person gait assessments
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.
Must have claims data available and consent to sharing.
Exclusion Criteria:
Hearing impairment with or without the use of hearing aids such that the participant cannot hear the rhythmic stimulation of the music
Pain that impairs walking ability
Unable to safely participate in walking sessions as determined by investigator
Requires more than one rest (seated or not) during the 6MWT
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.
People who are pregnant or become pregnant (due to expected gait pattern changes).
Lower limb prosthetic
More than 2 falls in the previous month
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.
Treatment with a gait-based investigational intervention within the last 3 months.
Unable or unwilling to provide informed consent to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Carlowicz, MPH
Phone
207-200-4482
Email
ccarlowicz@medrhythms.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Taylor, PhD
Phone
415-347-5339
Email
staylor@medrhythms.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Bethoux, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Curavit Clinical Research
Email
orchestras@curavit.io
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation
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