MR-010 Device for Stroke

Recruiting in Palo Alto (17 mi)

Overseen byBrian Silver, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Massachusetts, Worcester

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Brian Silver, MD

Principal Investigator

UMass Medical School

Eligibility Criteria

This trial is for adults over 18 who've had a stroke within the last 24 hours, can walk at certain speeds with some gait asymmetry, and speak English fluently. They must be able to participate in physical therapy and consent to study procedures. Excluded are those with recent orthopedic surgery, severe communication disorders, hearing impairments, or other serious health issues.

Inclusion Criteria

I was admitted for a stroke less than 24 hours ago.

I agree to follow the study plan and communicate with my doctor as needed.

I can walk at a speed between 0.4m/s and 1.0m/s.

See 6 more

Exclusion Criteria

You have other health problems that make it hard for you to exercise, such as issues with muscles, heart, lungs, or nerves (except for stroke).

You use a prosthetic leg.

I have severe difficulty speaking or understanding language.

See 5 more

Treatment Details

Interventions

MR-010 (Behavioural Intervention)

Trial OverviewThe MR-010's effects on walking ability post-stroke are being tested. This includes its impact on tolerability, biomechanics of walking, speed improvement during recovery in acute care settings, and whether it affects hospital stay duration.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: MR-010 walking therapyExperimental Treatment1 Intervention

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.

Group II: Standard of CareActive Control1 Intervention

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