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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Boston University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry Ellis, PT, Ph.D. | College of Health & Rehabilitation Sciences: Sargent College | Principal Investigator |
| Alex Pantelyat, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States | ||
| Boston University College of Health & Rehabilitation: Sargent College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37840504 | Derived | Zajac JA, Porciuncula F, Cavanaugh JT, McGregor C, Harris BA, Smayda KE, Awad LN, Pantelyat A, Ellis TD. Feasibility and Proof-of-Concept of Delivering an Autonomous Music-Based Digital Walking Intervention to Persons with Parkinson's Disease in a Naturalistic Setting. J Parkinsons Dis. 2023;13(7):1253-1265. doi: 10.3233/JPD-230169. |
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Additional participants were enrolled to account for possible attrition.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | percent of sessions completed | 28 days |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Sample size was small and consisted of highly educated, relatively active person with mild to moderate disease severity, potentially limiting generalizability to a less active PD population with greater disease severity. The study duration of 4 weeks was relatively short and lacked a control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terry Ellis PT, PhD, FAPTA | Boston University Department of Physical Therapy & Athletic Training | 617-353-7571 | tellis@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 29, 2023 | Sep 18, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2023 | Sep 18, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
|
| 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 |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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 | Posted | Number | adverse events | 28 days |
|
|
|
| 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. | Posted | Number | percentage of responses in a category | 28 days |
|
|
|
| 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 | Data for analysis was only obtained from 21 participants due to procedural error in instructions/administration of the test. | Posted | Mean | Standard Deviation | score on a scale | 28 days |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 28 days |
|
|
|
| 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) | Posted | Mean | Standard Deviation | meters | 28 days |
|
|
|
| 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) | Posted | Mean | Standard Deviation | meters per second | 28 days |
|
|
|
| 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. | Data from only 21 participants was available for analysis due to procedural error in instructions/administration of test. | Posted | Mean | Standard Deviation | score on a scale | 28 days |
|
|
|
| Secondary | Change in Mobility | Change in mobility as measured by the Five Times Sit to Stand Test | 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. | Posted | Mean | Standard Deviation | seconds | 28 days |
|
|
|
| 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) | 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. | Posted | Mean | Standard Deviation | daily steps | 8 days |
|
|
|
| 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) | 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. | Posted | Mean | Standard Deviation | moderate intensity minutes | 8 days |
|
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| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Title | Measurements |
|---|
|