Status:
TERMINATED
Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
MedRhythms, Inc.
Conditions:
Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this clinical pilot study is to evaluate the effects of the MR-010 on tolerability, biomechanics and walking speed in the acute stroke care setting in addition to its impact on length o...
Eligibility Criteria
Inclusion
- Must be 18 years of age or older.
- Must be able to read and speak English fluently.
- Be within 24 hours from admission for confirmed stroke event.
- Currently able to walk at a speed greater or equal to 0.4m/s, but less than 1.0m/s, as determined by a 10-meter walk test for comfortable walking speed (the average of three trials).
- Demonstrates some level of asymmetry in gait.
- Is expected to be discharged from the acute care setting requiring physical therapy per standard of care and participant has verbally committed to receiving at least one therapy session.
- Able and willing to consent with proposed study schema (verbal commitment), including consent to participate in communication with the treating clinician (as needed) during the study period.
- Score ≤1 on question 1b and a 0 on question 1c on the NIH Stroke Scale.
- Able to safely participate in protocol-defined walking therapy sessions of 30-minute duration as determined by the Investigator.
Exclusion
- Participant unable or unwilling to provide informed consent.
- Has a known history of neurologic (excluding stroke) injury.
- Has severe aphasia and/or a speech/language disorder, limiting ability to express needs and comprehend instructions.
- Has an external lower limb prosthetic ("artificial limb").
- Has a hearing impairment.
- Had orthopedic surgery in the last year.
- Has co-morbidities that prevent participation in exercise (for example: musculoskeletal, cardiovascular, pulmonary and neurological - other than stroke).
- Vulnerable populations as deemed inappropriate for study by site Principal Investigator.
Key Trial Info
Start Date :
November 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04689256
Start Date
November 3 2021
End Date
January 30 2023
Last Update
January 8 2025
Active Locations (1)
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1
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655