Status:
COMPLETED
Facilitators and Barriers to the Clinical Implementation of MR-001
Lead Sponsor:
MedRhythms, Inc.
Conditions:
Chronic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 implementati...
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 Audit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT06003790
Start Date
August 29 2023
End Date
April 30 2024
Last Update
November 19 2024
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
3
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195