Chronic StrokeRhaPSodyNCT06003790
Facilitators and Barriers to the Clinical Implementation of MR-001
A study testing MR-001 in people with Chronic Stroke, run by MedRhythms, Inc. at 3 sites in United States.
Trial summary
This is a single arm, multi-site, prospective hybrid implementation and feasibility trial. The primary purpose of this trial is to gather data on the facilitators and barriers to clinical implementation of MR-001 for patients with chronic stroke who experience walking impairments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- MR-001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Aug 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>18y/o) who have a history of stroke, now in the chronic phase, and with a clinically-relevant walking deficit, as determined by the Principal Investigator (PI).
- Able and willing to self-consent and comply with the proposed study schema.
- Per PI discretion, individuals who would likely be recommended home use of the MR-001 intervention and considered able to safely participate in independent protocol-defined walking therapy sessions.
Who cannot join
- Previous use of MR-001, as self-reported by the potential participant.
- Past medical history that prevents participation, as determined by PI's clinical judgment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Characterization of the Facilitators and Barriers to the Clinical Implementation of MR-001 for Community-dwelling Chronic Stroke Patients Who Have Walking Impairments
This is a single arm, multi-site, prospective hybrid implementation and feasibility trial. The primary purpose of this trial is to gather data on the facilitators and barriers to clinical implementation of MR-001 for patients with chronic stroke who experience walking impairments. Secondarily, the trial will evaluate the feasibility of MR-001 clinically impacting walking capacity, quality of life, mood, and cognition.
The goal of this single arm, multi-site, prospective hybrid implementation and feasibility trial is to gather data on the facilitators and barriers to clinical implementation of MR-001 for patient with chronic stroke who experience walking impairments. The main questions it aims to answer are:
Read more
- Enhance understanding of the potential clinical and operational needs and opportunities that may be associated with implementation of MR-001 in various treatment settings.
- Assess the impact of MR-001 on walking capacity.
- Assess the impact of MR-001 on quality of life and mood.
- Assess the impact of MR-001 on cognition.
All participants will be prescribed MR-001 and will be asked to walk with it for 30 minutes, 3 times weekly, for 8 weeks.
Read the detailed description
MR-001 is a medical device providing in-home outpatient rehabilitative therapy intended to improve walking and ambulation status in adult chronic stroke patients. The device is based on Rhythmic Auditory Stimulation (RAS) and is designed to operate digitally and autonomously. RAS is a therapy supported by rigorous research of both the foundational neuroscience mechanisms and its clinical application.
The scientific principle of "auditory-motor entrainment" is the basis for the standardized clinical intervention of RAS. Studies have shown that there is rich connectivity between the auditory and motor systems via multiple cortical and subcortical networks. Specifically, it has been shown that the auditory and motor system can synchronize subconsciously to an external, auditory rhythmic cue, a phenomenon known as "auditory-motor entrainment" (also referred to as "entrainment"). The auditory rhythm provides a consistent temporal structure for synchronization between these two systems. This consistent structure is used to subconsciously inform the brain where the next movement should be.
The primary endpoint of this study will be the evaluation of the implementation of MR-001 in clinical settings, including but not limited to hospital systems, outpatient rehabilitation centers, and non-acute clinic settings. This evaluation will include detailed qualitative feedback from clinicians on suitable implementation strategies for deploying MR-001, characterization of the facilitators and barriers to delivering MR-001 to chronic stroke patients, characterization of the enrolled patient profile, and characterization of the participant experience and satisfaction with MR-001. Secondary endpoints for this study will evaluate the impact of MR-001 on walking capacity, quality of life, mood, and cognition.
- Conditions
- Chronic Stroke
- Being tested
- MR-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-001Device
Use of device 3 times per week for 8 weeks - for a total of 24 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive MR-001 delivered to their home via mail. Participants will be asked to use the device for 24 sessions, 3 times a week for 8 weeks. Receives: Device: MR-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhance understanding of the potential clinical and operational needs and opportunities that may be associated with implementation of MR-001 in various treatment settings.
Accomplished by qualitative data collection via prescriber interviews collected up to 3 times during the indicated time frame. These interviews will focus on feedback from prescribers on suitable implementation strategies for deploying MR-001; facilitators and barriers to delivering MR-001 to chronic stroke patients; characterization of the enrolled patient profile, and the enrolled participant experience and satisfaction with MR-001.
Measured: 8 weeks
Secondary outcomes (8)
2 Minute Walk Test (2MWT)
Assessed by directional improvement of participants on the 2 Minute Walk Test (2MWT) pre vs post MR-001 intervention.
Measured: 8 weeks
Patient Health Questionnaire (PHQ-8)
Proportion of participants who directionally improve self-report of depression severity as measured by the Patient Health Questionnaire (PHQ-8) pre vs post MR-001 intervention.
Measured: 8 weeks
Trails Making Test Part A (TMT-A)
Proportion of participants who directionally improve processing speed as measured by Trail Making Test Part A (TMT-A) pre vs post MR-001 intervention.
Measured: 8 weeks
Short Falls Efficacy Scale International (Short FES-I)
Proportion of participants who directionally improve with regard to their concerns about falling as measured by the Short Falls Efficacy Scale International (Short FES-I) pre vs post MR-001 intervention.
Measured: 8 weeks
Generalized Anxiety Disorder (GAD-7) Questionnaire
Proportion of participants who directionally improve self-report of severity of generalized anxiety as measured by the Generalized Anxiety Disorder (GAD-7) questionnaire pre vs post MR-001 intervention.
Measured: 8 weeks
Trail Making Test Park B (TMT-B)
Proportion of participants who directionally improve set-shifting (executive function) as measured by Trail Making Test Part B (TMT-B) pre vs post MR-001 intervention.
Measured: 8 weeks
Stroke Impact Scale (SIS) Memory & Thinking Subtest
Proportion of participants who directionally improve self-reported thinking ability as measured by the Stroke Impact Scale (Memory \& Thinking subtest only) pre vs post MR-001 intervention.
Measured: 8 weeks
Patients' Global Impression of Change Scale (PGIC)
Proportion of participants who directionally improve self-reported degree of change as measured by the Patients' Global Impression of Change (PGIC) scale.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start29 Aug 2023
- Primary completion12 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, multi-site, prospective hybrid implementation and feasibility trial.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedRhythms, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sabrina Taylor, PhD, Study director, MedRhythms, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003790
- Sponsor's protocol ID
- PS200
- Acronym
- RhaPSody
- Status last verified
- Nov 2024
- First submitted
- 7 Aug 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Facilitators and Barriers to the Clinical Implementation of MR-001 for Community-dwelling Chronic Stroke Patients Who Have Walking Impairments
- ClinicalTrials.gov ID
- NCT06003790
- Acronym / sponsor ID
- RhaPSody / PS200
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- MedRhythms, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm, multi-site, prospective hybrid implementation and feasibility trial. The primary purpose of this trial is to gather data on the facilitators and barriers to clinical implementation of MR-001 for patients with chronic stroke who experience walking impairments. Secondarily, the trial will evaluate the feasibility of MR-001 clinically impacting walking capacity, quality of life, mood, and cognition.
The goal of this single arm, multi-site, prospective hybrid implementation and feasibility trial is to gather data on the facilitators and barriers to clinical implementation of MR-001 for patient with chronic stroke who experience walking impairments. The main questions it aims to answer are:
- Enhance understanding of the potential clinical and operational needs and opportunities that may be associated with implementation of MR-001 in various treatment settings.
- Assess the impact of MR-001 on walking capacity.
- Assess the impact of MR-001 on quality of life and mood.
- Assess the impact of MR-001 on cognition.
All participants will be prescribed MR-001 and will be asked to walk with it for 30 minutes, 3 times weekly, for 8 weeks.
Detailed description
MR-001 is a medical device providing in-home outpatient rehabilitative therapy intended to improve walking and ambulation status in adult chronic stroke patients. The device is based on Rhythmic Auditory Stimulation (RAS) and is designed to operate digitally and autonomously. RAS is a therapy supported by rigorous research of both the foundational neuroscience mechanisms and its clinical application.
The scientific principle of "auditory-motor entrainment" is the basis for the standardized clinical intervention of RAS. Studies have shown that there is rich connectivity between the auditory and motor systems via multiple cortical and subcortical networks. Specifically, it has been shown that the auditory and motor system can synchronize subconsciously to an external, auditory rhythmic cue, a phenomenon known as "auditory-motor entrainment" (also referred to as "entrainment"). The auditory rhythm provides a consistent temporal structure for synchronization between these two systems. This consistent structure is used to subconsciously inform the brain where the next movement should be.
The primary endpoint of this study will be the evaluation of the implementation of MR-001 in clinical settings, including but not limited to hospital systems, outpatient rehabilitation centers, and non-acute clinic settings. This evaluation will include detailed qualitative feedback from clinicians on suitable implementation strategies for deploying MR-001, characterization of the facilitators and barriers to delivering MR-001 to chronic stroke patients, characterization of the enrolled patient profile, and characterization of the participant experience and satisfaction with MR-001. Secondary endpoints for this study will evaluate the impact of MR-001 on walking capacity, quality of life, mood, and cognition.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, multi-site, prospective hybrid implementation and feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: MR-001Participants will receive MR-001 delivered to their home via mail. Participants will be asked to use the device for 24 sessions, 3 times a week for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (>18y/o) who have a history of stroke, now in the chronic phase, and with a clinically-relevant walking deficit, as determined by the Principal Investigator (PI).
- Able and willing to self-consent and comply with the proposed study schema.
- Per PI discretion, individuals who would likely be recommended home use of the MR-001 intervention and considered able to safely participate in independent protocol-defined walking therapy sessions.
Key exclusion criteria (2 listed)
- Previous use of MR-001, as self-reported by the potential participant.
- Past medical history that prevents participation, as determined by PI's clinical judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-001Use of device 3 times per week for 8 weeks - for a total of 24 sessions. | Device | Intervention |
Primary outcome
Enhance understanding of the potential clinical and operational needs and opportunities that may be associated with implementation of MR-001 in various treatment settings.
Time frame: 8 weeks
Accomplished by qualitative data collection via prescriber interviews collected up to 3 times during the indicated time frame. These interviews will focus on feedback from prescribers on suitable implementation strategies for deploying MR-001; facilitators and barriers to delivering MR-001 to chronic stroke patients; characterization of the enrolled patient profile, and the enrolled participant experience and satisfaction with MR-001.
8 secondary outcomes
2 Minute Walk Test (2MWT)
Time frame: 8 weeks
Patient Health Questionnaire (PHQ-8)
Time frame: 8 weeks
Trails Making Test Part A (TMT-A)
Time frame: 8 weeks
Short Falls Efficacy Scale International (Short FES-I)
Time frame: 8 weeks
Generalized Anxiety Disorder (GAD-7) Questionnaire
Time frame: 8 weeks
Trail Making Test Park B (TMT-B)
Time frame: 8 weeks
Stroke Impact Scale (SIS) Memory & Thinking Subtest
Time frame: 8 weeks
Patients' Global Impression of Change Scale (PGIC)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina Taylor, PhD study director
MedRhythms, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-001 in people with Chronic Stroke, run by MedRhythms, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhance understanding of the potential clinical and operational needs and opportunities that may be associated with implementation of MR-001 in various treatment settings. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.