Parkinson Disease
Conditions
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.
Interventions
DEVICEWalking 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.
Sponsors
Johns Hopkins University
Boston University
MedRhythms, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Adherence (Feasibility) to Walking Program Schedule Based on Percentage of Scheduled Sessions Completed | 28 days | Percentage of scheduled sessions completed (5 times per week for 4 weeks) |
| Safety (Feasibility) Based on the Number of Adverse Events During Training | 28 days | 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. | 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. |
| Change in Mobility Impact Based on the Mobility Dimension of the Parkinson's Disease Questionnaire-39 (PDQ-39) Between Baseline to Last Visit | 28 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mobility | 28 days | Change in mobility as measured by the Five Times Sit to Stand Test |
| Change in Disease Severity Based on the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) | 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. |
| Change in Intensity (Moderate Intensity Minutes; >100 Steps/Min) | 8 days | 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) |
| Change in Amount of Walking (Steps/Day) | 8 days | 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 Walking Endurance (m) | 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) |
| Change in Fast Walking Gait Speed (m/s) | 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) |
| Overall Quality of Life Impact Based on the Total Parkinson's Disease Questionnaire -39 (PDQ-39) | 28 days | 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. |
Countries
United States
Participant flow
Pre-assignment details
Additional participants were enrolled to account for possible attrition.
Participants by arm
| Arm | Count |
|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System 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. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Screen failure after consent | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 77.91 years STANDARD_DEVIATION 8.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
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
Time frame: 28 days
Population: Data for analysis was only obtained from 21 participants due to procedural error in instructions/administration of the test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | 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 |
Primary
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)
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | 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
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
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | Safety (Feasibility) Based on the Number of Adverse Events During Training | 0 adverse events |
Primary
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.
Time frame: 28 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire. | Disagree | 21.06 percentage of responses in a category |
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire. | Neutral | 13.37 percentage of responses in a category |
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | Usability (Feasibility) Based on Participant Ratings on Acceptability and Usability Questionnaire. | Agree | 65.57 percentage of responses in a category |
Secondary
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | Change in Amount of Walking (Steps/Day) | 3484 daily steps | Standard Deviation 4663 |
Secondary
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.
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | 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
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)
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | Change in Fast Walking Gait Speed (m/s) | 0.001 meters per second | Standard Deviation 0.17 |
Secondary
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | Change in Intensity (Moderate Intensity Minutes; >100 Steps/Min) | 21.44 moderate intensity minutes | Standard Deviation 23.11 |
Secondary
Change in Mobility
Change in mobility as measured by the Five Times Sit to Stand Test
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | Change in Mobility | -1.46 seconds | Standard Deviation 1.73 |
Secondary
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)
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | Change in Walking Endurance (m) | 13.83 meters | Standard Deviation 29.43 |
Secondary
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.
Time frame: 28 days
Population: Data from only 21 participants was available for analysis due to procedural error in instructions/administration of test.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Program With a Music-based, Rhythm-modulating Wearable Sensor System | 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 |