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

NCT04689256 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-01-08

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • MedRhythms, Inc.

    collaborator INDUSTRY

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Brian Silver, MD · UMass Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2023-01-30
Completion
2023-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04689256 on ClinicalTrials.gov