Clinical trial NCT06003790: Facilitators and Barriers to the Clinical Implementation of MR-001
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: MedRhythms, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, multi-site, prospective hybrid implementation and feasibility trial.
Primary purpose: OTHER

Brief 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. 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:

1. Enhance understanding of the potential clinical and operational needs and opportunities that may be associated with implementation of MR-001 in various treatment settings.
2. Assess the impact of MR-001 on walking capacity.
3. Assess the impact of MR-001 on quality of life and mood.
4. 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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. Able and willing to self-consent and comply with the proposed study schema.
3. 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.

Exclusion Criteria:

1. Previous use of MR-001, as self-reported by the potential participant.
2. Past medical history that prevents participation, as determined by PI's clinical judgment.

Primary outcomes:
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.
timeFrame: 8 weeks
Secondary outcomes:
measure: 2 Minute Walk Test (2MWT)
timeFrame: 8 weeks
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: 8 weeks
measure: Trails Making Test Part A (TMT-A)
timeFrame: 8 weeks
measure: Short Falls Efficacy Scale International (Short FES-I)
timeFrame: 8 weeks
measure: Generalized Anxiety Disorder (GAD-7) Questionnaire
timeFrame: 8 weeks
measure: Trail Making Test Park B (TMT-B)
timeFrame: 8 weeks
measure: Stroke Impact Scale (SIS) Memory & Thinking Subtest
timeFrame: 8 weeks
measure: Patients' Global Impression of Change Scale (PGIC)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: MedRhythms, Inc.
name: Sabrina Taylor, PhD
role: STUDY_DIRECTOR
References: