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Facilitators and Barriers to the Clinical Implementation of MR-001

NCT06003790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-11-19

No results posted yet for this study

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.

Conditions

  • Chronic Stroke

Interventions

DEVICE

MR-001

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

Sponsors & Collaborators

  • MedRhythms, Inc.

    lead INDUSTRY

Principal Investigators

  • Sabrina Taylor, PhD · MedRhythms, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-29
Primary Completion
2024-04-12
Completion
2024-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06003790 on ClinicalTrials.gov