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

Primary Purpose

Stroke, Acute

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR-010
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UMass Chan Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MR-010 walking therapy

Standard of Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of stay
Median length of stay in acute stroke hospital
Readmission to hospital
Percent of readmission to hospital following discharge

Full Information

First Posted
December 28, 2020
Last Updated
May 10, 2023
Sponsor
University of Massachusetts, Worcester
Collaborators
MedRhythms, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04689256
Brief Title
Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke
Official Title
Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
MedRhythms, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MR-010 walking therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Subjects will undergo a 10-meter walk test bi-weekly for 90 days and at 45 and 90 days
Intervention Type
Device
Intervention Name(s)
MR-010
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in gait speed (m/s)
Description
Change in gait speed (m/s) from baseline to study completion
Time Frame
90 days
Title
Adherence to MR-010 therapy schedule
Description
Percentage of scheduled sessions completed (3 times per week for 12 weeks)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Length of stay
Description
Median length of stay in acute stroke hospital
Time Frame
Duration of hospital stay, average 5 days
Title
Readmission to hospital
Description
Percent of readmission to hospital following discharge
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Silver, MD
Phone
508-334-2527
Email
brian.silver@umassmemorial.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Manxhari, BA
Phone
774-455-6568
Email
christina.manxhari@umassmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Silver, MD
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Silver, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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