Trial Outcomes & Findings for Feasibility and Preliminary Effects of MR-005 in Persons With Parkinson Disease (NCT NCT04891107)

Results Overview

Percentage of scheduled sessions completed (5 times per week for 4 weeks)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

28 days

Results posted on

2023-12-12

Participant Flow

Additional participants were enrolled to account for possible attrition.

Participant milestones

Participant milestones
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Overall Study STARTED	26
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1
Overall Study Screen failure after consent	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=23 Participants Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	77.91 years STANDARD_DEVIATION 8.78 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Percentage of scheduled sessions completed (5 times per week for 4 weeks)

Outcome measures

Outcome measures
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=23 Participants 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Observed Adherence (Feasibility) to Walking Program Schedule Based on Percentage of Scheduled Sessions Completed	86.08696 percent of sessions completed Standard Deviation 16.02246

PRIMARY outcome

Timeframe: 28 days

Safety as assessed by number of adverse events during training with the music-based device

Outcome measures

Outcome measures
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=23 Participants 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Safety (Feasibility) Based on the Number of Adverse Events During Training	0 adverse events

PRIMARY outcome

Timeframe: 28 days

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.

Outcome measures

Outcome measures
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=21 Participants 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire. Disagree	21.06 percentage of responses in a category
Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire. Neutral	13.37 percentage of responses in a category
Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire. Agree	65.57 percentage of responses in a category

PRIMARY outcome

Timeframe: 28 days

Population: Data for analysis was only obtained from 21 participants due to procedural error in instructions/administration of the test.

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

Outcome measures

Outcome measures
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=21 Participants 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Change in Mobility Impact Based on the Mobility Dimension of the Parkinson's Disease Questionnaire-39 (PDQ-39) Between Baseline to Last Visit	-1.81 score on a scale Standard Deviation 7.61

SECONDARY outcome

Timeframe: 28 days

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.

Outcome measures

Outcome measures
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=23 Participants 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Change in Disease Severity Based on the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)	-3.67 score on a scale Standard Deviation 5.89

SECONDARY outcome

Timeframe: 28 days

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)

Outcome measures

Outcome measures
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=23 Participants 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Change in Walking Endurance (m)	13.83 meters Standard Deviation 29.43

SECONDARY outcome

Timeframe: 28 days

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)

Outcome measures

Outcome measures
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=21 Participants 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Change in Fast Walking Gait Speed (m/s)	0.001 meters per second Standard Deviation 0.17

SECONDARY outcome

Timeframe: 28 days

Population: Data from only 21 participants was available for analysis due to procedural error in instructions/administration of test.

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.

Outcome measures

Outcome measures
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=21 Participants 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Overall Quality of Life Impact Based on the Total Parkinson's Disease Questionnaire -39 (PDQ-39)	-2.68 score on a scale Standard Deviation 5.14

SECONDARY outcome

Timeframe: 28 days

Population: Data for analysis was available for 20 participants due to due to participant inability to to perform test, therefore there was no compare functional mobility pre- and post-intervention.

Change in mobility as measured by the Five Times Sit to Stand Test

Outcome measures

Outcome measures
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=20 Participants 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Change in Mobility	-1.46 seconds Standard Deviation 1.73

SECONDARY outcome

Timeframe: 8 days

Population: Data analysis available for 16 participants. Seven (7) participants had no SAM baseline data, therefore the study team could not analyze walking amount pre- and post-intervention for this measure for those participants.

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)

Outcome measures

Outcome measures
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=16 Participants 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Change in Amount of Walking (Steps/Day)	3484 daily steps Standard Deviation 4663

SECONDARY outcome

Timeframe: 8 days

Population: Data analysis is available for 16 participants. Seven (7) participants did not have baseline SAM data available, therefore the study team could not analyze pre- and post-intervention changes in moderate intensity minutes for these participants.

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)

Outcome measures

Outcome measures
Measure	Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System n=16 Participants 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. Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System: 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.
Change in Intensity (Moderate Intensity Minutes; >100 Steps/Min)	21.44 moderate intensity minutes Standard Deviation 23.11

Adverse Events

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Terry Ellis PT, PhD, FAPTA

Boston University Department of Physical Therapy & Athletic Training

Phone: 617-353-7571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place