search
Back to results

Feasibility and Preliminary Effects of MR-005 in Persons With Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System
Sponsored by
MedRhythms, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of idiopathic, typical Parkinson disease.
  • Modified Hoehn and Yahr stages 1-3 per physical exam.
  • Able to walk independently without physical assistance or an assistive device.

Exclusion Criteria:

  • Diagnosis of atypical Parkinsonism.
  • Moderately or significantly disturbing freezing episodes during daily walking.
  • Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA).
  • Significant hearing impairment.
  • Currently participating in physical therapy.
  • Cardiac problems that interfere with the ability to safely exercise.
  • Orthopedic problems in the lower extremities or spine that may limit walking distance.

Sites / Locations

  • Johns Hopkins University School of Medicine
  • Boston University College of Health & Rehabilitation: Sargent College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System

Arm Description

Will walk for 30 minutes at a time, 5 times a week, for 4 weeks using the wearable sensor system at home or in the community.

Outcomes

Primary Outcome Measures

Observed adherence (feasibility) to walking program schedule based on percentage of scheduled sessions completed
Percentage of scheduled sessions completed (5 times per week for 4 weeks)
Safety (feasibility) based on the number of adverse events during training
Safety as assessed by number of adverse events during training with the music-based device
Usability (feasibility) based on participant ratings on Acceptability and Usability Questionnaire.
Usability as assessed by participant ratings on Acceptability and Usability Questionnaire. The Questionnaire is a 26-item measure with three Likert Scale responses (disagree, neutral, agree).
Mobility impact based on the mobility dimension of the Parkinson's Disease Questionnaire-39 (PDQ-39)
Mobility impact as assessed by Parkinson's Disease Questionnaire-39 (PDQ-39) mobility dimension (questions #1-10 from the total PDQ-39 questionnaire). Scores are on a 0-4 Likert Scale (lower scores equaling better quality of life), summed, and then transformed into the total PDQ-39 that ranges from 0-100. Lower scores represent better quality of life.

Secondary Outcome Measures

Change in disease severity based on the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)
Change in disease severity at baseline as compared to end of study participation (or earlier if study participant withdraws) as determined by the MDS-UPDRS III. Scores range between 0-132 with lower scores represent less disease severity.
Change in walking endurance (m)
Change in walking endurance (m) at baseline as compared to end of study participation (or earlier if study participant withdraws) as determined by the 6 Minute Walk Test (6MWT)
Change in gait speed (m/s)
Change in gait speed (m/s) at baseline as compared to end of study participation (or earlier if study participant withdraws) as determined by the 10 Meter Walk Test (10MWT)
Overall quality of life impact based on the total Parkinson's Disease Questionnaire -39 (PDQ-39)
Overall quality of life impact at baseline as compared to end of study participation (or earlier if study participant withdraws) as assessed by Parkinson's Disease Questionnaire-39 (PDQ-39). The PDQ-39 contains 8 dimensions of function and well-being which are summed to generate the total PDQ-39 score (ranging from 0-100) where lower scores represent better quality of life.
Change in mobility
Change in mobility as measured by the Five Times Sit to Stand Test
Change in amount of walking (steps/day)
Change in amount (steps/day) of walking activity (proof-of-concept) at baseline as compared to during training as measured by the StepWatch Activity Monitor (SAM)
Change in intensity (moderate intensity minutes; >100 steps/min)
Change in intensity (moderate intensity minutes; >100 steps/min) of walking activity (proof-of-concept) at baseline as compared to during training as measured by the StepWatch Activity Monitor (SAM)

Full Information

First Posted
April 28, 2021
Last Updated
February 22, 2023
Sponsor
MedRhythms, Inc.
Collaborators
Johns Hopkins University, Sargent College of Health and Rehabilitation Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04891107
Brief Title
Feasibility and Preliminary Effects of MR-005 in Persons With Parkinson Disease
Official Title
Feasibility and Preliminary Effects of Using a Music-based, Rhythm-modulating Wearable Sensor System in the Community in Persons With Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
June 8, 2022 (Actual)
Study Completion Date
June 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedRhythms, Inc.
Collaborators
Johns Hopkins University, Sargent College of Health and Rehabilitation Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical study is to evaluate the effects of music, tailored to the participant's cadence, on adherence, quality of life, gait speed, functional mobility, and walking activity in individuals with Parkinson disease when used in the home and community environment.
Detailed Description
Persons with Parkinson disease will be enrolled to determine the effects of a community walking program with a music-based device on adherence, quality of life, walking speed and walking activity. The walking program will be carried out independently by participants in their home/community environment. Noninvasive functional assessments commonly administered in clinical practice will be used to measure the variables of interest.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System
Arm Type
Experimental
Arm Description
Will walk for 30 minutes at a time, 5 times a week, for 4 weeks using the wearable sensor system at home or in the community.
Intervention Type
Device
Intervention Name(s)
Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System
Other Intervention Name(s)
MedRhythms MR-005 Device
Intervention Description
Participants will walk using the music-based, rhythm-modulating wearable sensor system (foot sensors, mobile device with mobile app and headphones) for thirty (30) minutes at a time, 5 times a week for 4 weeks.
Primary Outcome Measure Information:
Title
Observed adherence (feasibility) to walking program schedule based on percentage of scheduled sessions completed
Description
Percentage of scheduled sessions completed (5 times per week for 4 weeks)
Time Frame
28 days
Title
Safety (feasibility) based on the number of adverse events during training
Description
Safety as assessed by number of adverse events during training with the music-based device
Time Frame
28 days
Title
Usability (feasibility) based on participant ratings on Acceptability and Usability Questionnaire.
Description
Usability as assessed by participant ratings on Acceptability and Usability Questionnaire. The Questionnaire is a 26-item measure with three Likert Scale responses (disagree, neutral, agree).
Time Frame
28 days
Title
Mobility impact based on the mobility dimension of the Parkinson's Disease Questionnaire-39 (PDQ-39)
Description
Mobility impact as assessed by Parkinson's Disease Questionnaire-39 (PDQ-39) mobility dimension (questions #1-10 from the total PDQ-39 questionnaire). Scores are on a 0-4 Likert Scale (lower scores equaling better quality of life), summed, and then transformed into the total PDQ-39 that ranges from 0-100. Lower scores represent better quality of life.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Change in disease severity based on the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)
Description
Change in disease severity at baseline as compared to end of study participation (or earlier if study participant withdraws) as determined by the MDS-UPDRS III. Scores range between 0-132 with lower scores represent less disease severity.
Time Frame
28 days
Title
Change in walking endurance (m)
Description
Change in walking endurance (m) at baseline as compared to end of study participation (or earlier if study participant withdraws) as determined by the 6 Minute Walk Test (6MWT)
Time Frame
28 days
Title
Change in gait speed (m/s)
Description
Change in gait speed (m/s) at baseline as compared to end of study participation (or earlier if study participant withdraws) as determined by the 10 Meter Walk Test (10MWT)
Time Frame
28 days
Title
Overall quality of life impact based on the total Parkinson's Disease Questionnaire -39 (PDQ-39)
Description
Overall quality of life impact at baseline as compared to end of study participation (or earlier if study participant withdraws) as assessed by Parkinson's Disease Questionnaire-39 (PDQ-39). The PDQ-39 contains 8 dimensions of function and well-being which are summed to generate the total PDQ-39 score (ranging from 0-100) where lower scores represent better quality of life.
Time Frame
28 days
Title
Change in mobility
Description
Change in mobility as measured by the Five Times Sit to Stand Test
Time Frame
28 days
Title
Change in amount of walking (steps/day)
Description
Change in amount (steps/day) of walking activity (proof-of-concept) at baseline as compared to during training as measured by the StepWatch Activity Monitor (SAM)
Time Frame
8 days
Title
Change in intensity (moderate intensity minutes; >100 steps/min)
Description
Change in intensity (moderate intensity minutes; >100 steps/min) of walking activity (proof-of-concept) at baseline as compared to during training as measured by the StepWatch Activity Monitor (SAM)
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of idiopathic, typical Parkinson disease. Modified Hoehn and Yahr stages 1-3 per physical exam. Able to walk independently without physical assistance or an assistive device. Exclusion Criteria: Diagnosis of atypical Parkinsonism. Moderately or significantly disturbing freezing episodes during daily walking. Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA). Significant hearing impairment. Currently participating in physical therapy. Cardiac problems that interfere with the ability to safely exercise. Orthopedic problems in the lower extremities or spine that may limit walking distance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Ellis, PT, Ph.D.
Organizational Affiliation
College of Health & Rehabilitation Sciences: Sargent College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex Pantelyat, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Boston University College of Health & Rehabilitation: Sargent College
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility and Preliminary Effects of MR-005 in Persons With Parkinson Disease

We'll reach out to this number within 24 hrs