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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility and Preliminary Effects of Using a Music-based, Rhythm-modulating Wearable Sensor System in the Community in Persons With Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System<br> | Device: Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System<br>* 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.<br>* Other names: MedRhythms MR-005 Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 28 days | 
| 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 | 28 days | 
| 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 comprised of adapted items from the System Usability Scale, Post Study System Usability Questionnaire, Technology Assessment Model Measurement Scales, and Usefulness, Satisfaction, and Ease questionnaire as described in Ben-Zeev D, et al., 2014. Participants were asked to rate their agreement with a series of statements about the intervention (26-items) using three Likert Scale responses (disagree, neutral, or agree) for each item. The number of responses in each category of disagree, neutral, or agree were summed and averaged across the total number of participants who responded to report an overall percentage within each category of disagree, neutral, or agree on the acceptability and usability of the device. A higher overall percentage of 'agree' responses indicate a higher degree of usability as rated by participants. | 28 days | 
| Change in Mobility Impact Based on the Mobility Dimension of the Parkinson's Disease Questionnaire-39 (PDQ-39) Between Baseline to Last Visit | Mobility impact as assessed by Parkinson's Disease Questionnaire-39 (PDQ-39) mobility dimension (questions #1-10 from the total PDQ-39 questionnaire). Each question is scored on a 0-4 ordinal scoring system then summed to generate the sub-scale score of the mobility dimension. Lower scores represent better quality of life. Mobility Dimension Subscale Range: 0-100 | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days | 
| 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) | 28 days | 
| Change in Fast Walking Gait Speed (m/s) | Change in fast walking 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) | 28 days | 
| 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. | 28 days | 
| Change in Mobility | Change in mobility as measured by the Five Times Sit to Stand Test | 28 days | 
| 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) | 8 days | 
| 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) | 8 days |