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

Not Applicable

Terminated

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 of stay.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
MR-010 walking therapy	MR-010	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.

Primary Outcome Measures

Name	Time	Method
Change in Gait Speed (m/s)	90 days	Change in gait speed (m/s) from baseline to study completion as measured by a 6 meter walking test.
Adherence to MR-010 Therapy Schedule	90 days	Adherence to the MR-010 therapy schedule is measured by the number of participants who completed scheduled sessions (3 times per week for 12 weeks)

Secondary Outcome Measures

Name	Time	Method
Length of Stay	Duration of hospital stay, up to 14 days	Median length of stay in acute stroke hospital
Readmission to Hospital	90 days	Percent of readmission to hospital following discharge