Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke

Stopped early · Not applicable

Conditions studied: Stroke, Acute

In brief

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 of stay.

Key facts

Study ID

NCT04689256

Run by

University of Massachusetts, Worcester

People needed

4

Starts

2021-11-03

Expected to finish

2023-01-30

Last updated by the study team

2025-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UMass Chan Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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