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

NCT04689256 | Terminated Results FDA Device

• 1 other identifier: H00021940
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Keywords

rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in Gait Speed (m/s)

  Change in gait speed (m/s) from baseline to study completion as measured by a 6 meter walking test.

  90 days

• Adherence to MR-010 Therapy Schedule

  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)

  90 days

Secondary Outcomes (2)

• Length of Stay

  Duration of hospital stay, up to 14 days

• Readmission to Hospital

  90 days

Study Arms (2)

MR-010 walking therapy

EXPERIMENTAL

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.

Device: MR-010

Standard of Care

NO INTERVENTION

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

Interventions

MR-010 DEVICE

MR-010 includes a patient application and sensors with commercially available headphones and smartphones. Sensors are placed on the subject's shoes and measure gait metrics. The algorithm uses data from the sensors to inform changes made to the audio cues. These cues, which are embedded in time-shifted music, are delivered back to the users who aim to walk to the beat.

MR-010 walking therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• MedRhythms, Inc.: collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

In this study, the intervention group opted not to use the devices or participate in interventions or self-measured data as outlined in the protocol. Further, the study was closed early due to slow enrollment.

Results Point of Contact

• Title: Dr. Brian Silver
• Organization: UMass Chan Medical School/UMass Memorial Health

Brian.Silver@umassmemorial.org

508-334-5989

Study Officials

• Brian Silver, MD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 30, 2020
• Study Start: November 3, 2021
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)