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

University of Massachusetts, Worcester

Status: Terminated

Conditions: Stroke, Acute

Treatments: Device: MR-010

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04689256

H00021940

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

MR-010 walking therapy

Experimental group

Description:

Subjects will use the MR-010 three times a week for 30 minutes per session for 90 days. Subjects will undergo a 10-meter walk test bi-weekly and at 45 and 90 days.

Treatment:

Device: MR-010

Standard of Care

No Intervention group

Description:

Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days