NCT06003790Completed
Facilitators and Barriers to the Clinical Implementation of MR-001
Characterization of the Facilitators and Barriers to the Clinical Implementation of MR-001 for Community-dwelling Chronic Stroke Patients Who Have Walking Impairments
Source: ClinicalTrials.gov · Last updated 19 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 7 Aug 2023
- Start date
- 29 Aug 2023
- Primary completion date
- 12 Apr 2024
- Lead sponsor
- MedRhythms, Inc.
- Diseases
- Stroke
- NCT number
- NCT06003790
What you commit to
- Study type: Interventional
- Participants enrolled: 31
- From 29 Aug 2023 to the primary completion date, 12 Apr 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous use of MR-001, as self-reported by the potential participant.
Other
- Past medical history that prevents participation, as determined by PI's clinical judgment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.