Facilitators and Barriers to the Clinical Implementation of MR-001

NCT06003790 | Completed FDA Device

• 1 other identifier: PS200
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

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. 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. 2.Assess the impact of MR-001 on walking capacity.
3. 3.Assess the impact of MR-001 on quality of life and mood.
4. 4.Assess the impact of MR-001 on cognition.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (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.

  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 weeks

Secondary Outcomes (8)

• 2 Minute Walk Test (2MWT)

  8 weeks

• Patient Health Questionnaire (PHQ-8)

  8 weeks

• Trails Making Test Part A (TMT-A)

  8 weeks

• Short Falls Efficacy Scale International (Short FES-I)

  8 weeks

• Generalized Anxiety Disorder (GAD-7) Questionnaire

  8 weeks

Study Arms (1)

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.

Device: MR-001

Interventions

MR-001 DEVICE

Use of device 3 times per week for 8 weeks - for a total of 24 sessions.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedRhythms, Inc.: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Sabrina Taylor, PhD

  MedRhythms, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, multi-site, prospective hybrid implementation and feasibility trial.

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 22, 2023
• Study Start: August 29, 2023
• Primary Completion: April 12, 2024
• Study Completion: April 30, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)