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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: MR-010

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Manxhari, BA; Phone Number: 774-455-6568; Email: christina.manxhari@umassmed.edu
• Study Contact Backup: Name: Brian Silver, MD; Phone Number: 508-334-2527; Email: brian.silver@umassmemorial.org

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • UMass Chan Medical School
      • Contact: Brian Silver, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MR-010 walking therapy; 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; 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.
No Intervention: Standard of Care; Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gait speed (m/s)	Change in gait speed (m/s) from baseline to study completion	90 days
Adherence to MR-010 therapy schedule	Percentage of scheduled sessions completed (3 times per week for 12 weeks)	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Median length of stay in acute stroke hospital	Duration of hospital stay, average 5 days
Readmission to hospital	Percent of readmission to hospital following discharge	90 days

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: MedRhythms, Inc.
• Investigators: Principal Investigator: Brian Silver, MD, UMass Medical School

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: H00021940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes