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

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ClinicalTrials.gov Identifier: NCT04689256
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : February 25, 2022
Sponsor:
Collaborator:
MedRhythms, Inc.
Information provided by (Responsible Party):
Brian Silver, University of Massachusetts, Worcester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Device: MR-010 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in gait speed (m/s) [ Time Frame: 90 days ]
    Change in gait speed (m/s) from baseline to study completion

  2. Adherence to MR-010 therapy schedule [ Time Frame: 90 days ]
    Percentage of scheduled sessions completed (3 times per week for 12 weeks)


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: Duration of hospital stay, average 5 days ]
    Median length of stay in acute stroke hospital

  2. Readmission to hospital [ Time Frame: 90 days ]
    Percent of readmission to hospital following discharge


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04689256


Contacts
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Contact: Brian Silver, MD 508-334-2527 brian.silver@umassmemorial.org
Contact: Christina Manxhari, BA 774-455-6568 christina.manxhari@umassmed.edu

Locations
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United States, Massachusetts
UMass Chan Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Brian Silver, MD         
Sponsors and Collaborators
University of Massachusetts, Worcester
MedRhythms, Inc.
Investigators
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Principal Investigator: Brian Silver, MD UMass Medical School
More Information
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Responsible Party: Brian Silver, Chair and Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT04689256    
Other Study ID Numbers: H00021940
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Brian Silver, University of Massachusetts, Worcester:
rehabilitation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases