Trial Outcomes & Findings for Amped-PD: Amplifying Physical Activity Through Music in Parkinson Disease (NCT NCT05421624)
NCT ID: NCT05421624
Last Updated: 2025-05-31
Results Overview
The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Baseline
Results posted on
2025-05-31
Participant Flow
Participant milestones
| Measure |
Amped-PD
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amped-PD: Amplifying Physical Activity Through Music in Parkinson Disease
Baseline characteristics by cohort
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=20 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Unified Parkinson's Disease Rating Scale Part III Score
|
20.71 Points
STANDARD_DEVIATION 7.68 • n=5 Participants
|
22.75 Points
STANDARD_DEVIATION 10.60 • n=7 Participants
|
20.73 Points
STANDARD_DEVIATION 8.57 • n=5 Participants
|
|
Age, Continuous
|
66.95 years
STANDARD_DEVIATION 8.84 • n=5 Participants
|
60.065 years
STANDARD_DEVIATION 9.13 • n=7 Participants
|
63.87 years
STANDARD_DEVIATION 9.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineThe amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=16 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Physical Activity Based on the Amount of Moderate Intensity Walking
|
9.45 minutes of moderate intensity walking
Standard Deviation 9.39
|
16.17 minutes of moderate intensity walking
Standard Deviation 18.08
|
PRIMARY outcome
Timeframe: During training up to 4 days from start of trainingThe amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=16 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Physical Activity Based on the Amount of Moderate Intensity Walking
|
32.83 minutes of moderate intensity walking
Standard Deviation 10.14
|
23.08 minutes of moderate intensity walking
Standard Deviation 12.09
|
PRIMARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=16 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Physical Activity Based on the Amount of Moderate Intensity Walking
|
30.30 minutes of moderate intensity walking
Standard Deviation 11.45
|
24.15 minutes of moderate intensity walking
Standard Deviation 15.23
|
PRIMARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention)The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=16 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Physical Activity Based on the Amount of Moderate Intensity Walking
|
6.85 minutes of moderate intensity walking
Standard Deviation 6.48
|
13.22 minutes of moderate intensity walking
Standard Deviation 9.62
|
PRIMARY outcome
Timeframe: BaselineDaily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=16 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Step Activity Based on Daily Step Counts
|
8812 steps
Standard Deviation 3453
|
10311 steps
Standard Deviation 3497
|
PRIMARY outcome
Timeframe: During training up to 4 days from start of trainingDaily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=16 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Step Activity Based on Daily Step Counts
|
12155 steps
Standard Deviation 3127
|
10483 steps
Standard Deviation 3751
|
PRIMARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=16 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Step Activity Based on Daily Step Counts
|
11346 steps
Standard Deviation 2665
|
10926 steps
Standard Deviation 2756
|
PRIMARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)Daily step counts refer to the total number of steps taken on the leg with the monitor. This will be measured using research-grade activity monitors (StepWatch Activity Monitor, Modus Health, Edmonds, WA) validated for use in PD.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=16 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Step Activity Based on Daily Step Counts
|
8407 steps
Standard Deviation 2967
|
8284 steps
Standard Deviation 3933
|
PRIMARY outcome
Timeframe: BaselineStride-to-stride variability of stride time of the gait cycle will be measured using wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Outcome measures
| Measure |
Amped-PD
n=19 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=15 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Gait Quality Based on Variability of Stride Time
|
4.19 %coefficient of variation
Standard Deviation 2.38
|
2.88 %coefficient of variation
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)Stride-to-stride variability of stride time of the gait cycle will be measured using wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Outcome measures
| Measure |
Amped-PD
n=19 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=15 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Gait Quality Based on Variability of Stride Time
|
3.46 %coefficient of variation
Standard Deviation 1.64
|
3.18 %coefficient of variation
Standard Deviation 1.07
|
PRIMARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)Stride-to-stride variability of stride time of the gait cycle will be measured using wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as percentage. Worse gait quality is indicated by higher stride time variability, while improved gait quality is indicated by lower stride time variability.
Outcome measures
| Measure |
Amped-PD
n=19 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=15 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Gait Quality Based on Variability of Stride Time
|
3.70 %coefficient of variation
Standard Deviation 2.01
|
3.05 %coefficient of variation
Standard Deviation 1.70
|
PRIMARY outcome
Timeframe: BaselineThe Self-Report Habit Index (SRHI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit strength. This self-report index comprises of 12 statements with constructs spanning behavior repetition, automaticity, and identity, with responses made on 11-point Likert scales (0 = strongly disagree; 10 = strongly agree). Higher scores indicate stronger habit formation (min = 0, max = 100).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Self-Report Habit Index (SRHI)
|
59.40 percent (out of 100%)
Standard Deviation 26.57
|
44.08 percent (out of 100%)
Standard Deviation 29.79
|
PRIMARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)The Self-Report Habit Index (SRHI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit strength. This self-report index comprises of 12 statements with constructs spanning behavior repetition, automaticity, and identity, with responses made on 11-point Likert scales (0 = strongly disagree; 10 = strongly agree). Higher scores indicate stronger habit formation (min = 0, max = 100).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Self-Report Habit Index (SRHI)
|
74.25 percent (out of 100%)
Standard Deviation 20.72
|
57.85 percent (out of 100%)
Standard Deviation 24.68
|
SECONDARY outcome
Timeframe: BaselineThis is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
|
1.16 m/s
Standard Deviation 0.15
|
1.27 m/s
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
|
1.18 m/s
Standard Deviation 0.16
|
1.32 m/s
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
|
1.18 m/s
Standard Deviation 0.14
|
1.36 m/s
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: BaselineThis is a test of short-distance walking function. The participant will be asked to walk at maximum walking speed (MWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
10-Meter Walk Test (10MWT) - Maximum Walking Speed
|
1.74 m/s
Standard Deviation 0.36
|
1.82 m/s
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)This is a test of short-distance walking function. The participant will be asked to walk at maximum walking speed (MWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
10-Meter Walk Test (10MWT) - Maximum Walking Speed
|
1.77 m/s
Standard Deviation 0.37
|
1.83 m/s
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)This is a test of short-distance walking function. The participant will be asked to walk at maximum walking speed (MWS) on a ten-meter straight walkway. Two trials will be administered, and the average of two trials will be reported.
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
10-Meter Walk Test (10MWT) - Maximum Walking Speed
|
1.80 m/s
Standard Deviation 0.36
|
1.80 m/s
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: BaselineThis is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
6-Minute Walk Test (6MWT)
|
520.32 m
Standard Deviation 86.99
|
548.56 m
Standard Deviation 79.93
|
SECONDARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
6-Minute Walk Test (6MWT)
|
524.56 m
Standard Deviation 83.56
|
562.31 m
Standard Deviation 84.79
|
SECONDARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test.
Outcome measures
| Measure |
Amped-PD
n=20 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
6-Minute Walk Test (6MWT)
|
533.31 m
Standard Deviation 92.65
|
570.98 m
Standard Deviation 83.06
|
SECONDARY outcome
Timeframe: BaselineQuantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Outcome measures
| Measure |
Amped-PD
n=19 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=15 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Gait Velocity During In-clinic Walking
|
1.50 m/s
Standard Deviation 0.26
|
1.58 m/s
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Outcome measures
| Measure |
Amped-PD
n=19 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=15 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Gait Velocity During In-clinic Walking
|
1.53 m/s
Standard Deviation 0.25
|
1.63 m/s
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Outcome measures
| Measure |
Amped-PD
n=19 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=15 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Gait Velocity During In-clinic Walking
|
1.55 m/s
Standard Deviation 0.26
|
1.63 m/s
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: BaselineQuantified metrics of stride length (m) will be collected using wearable sensors.
Outcome measures
| Measure |
Amped-PD
n=19 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=15 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Stride Length During In-clinic Walking
|
1.49 m
Standard Deviation 0.18
|
1.54 m
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)Quantified metrics of stride length (m) will be collected using wearable sensors.
Outcome measures
| Measure |
Amped-PD
n=19 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=15 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Stride Length During In-clinic Walking
|
1.52 m
Standard Deviation 0.20
|
1.56 m
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention)Quantified metrics of stride length (m) will be collected using wearable sensors.
Outcome measures
| Measure |
Amped-PD
n=19 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=15 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Stride Length During In-clinic Walking
|
1.53 m
Standard Deviation 0.20
|
1.56 m
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: BaselineThe MDS UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. The total score is reported, which can range from 0 (no impairment) to 141 (maximum impairment).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
|
20.71 points
Standard Deviation 7.68
|
22.75 points
Standard Deviation 10.60
|
SECONDARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)The MDS UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. The total score is reported, which can range from 0 (no impairment) to 141 (maximum impairment).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
|
23.48 points
Standard Deviation 9.41
|
21.11 points
Standard Deviation 18.74
|
SECONDARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)The MDS UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination (33 scores summed from 18 questions) conducted by the rater. The total score is reported, which can range from 0 (no impairment) to 141 (maximum impairment).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)
|
22.86 points
Standard Deviation 10.15
|
18.74 points
Standard Deviation 7.65
|
SECONDARY outcome
Timeframe: BaselineThe SEW-D is a 10-item self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Self-Efficacy of Walking - Duration (SEW-D)
|
73.76 percent
Standard Deviation 18.85
|
69.89 percent
Standard Deviation 18.83
|
SECONDARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)The SEW-D is a 10-item self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Self-Efficacy of Walking - Duration (SEW-D)
|
78.14 percent
Standard Deviation 19.49
|
76.95 percent
Standard Deviation 15.39
|
SECONDARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)The SEW-D is a 10-item self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Self-Efficacy of Walking - Duration (SEW-D)
|
78.57 percent
Standard Deviation 19.51
|
76.89 percent
Standard Deviation 19.48
|
SECONDARY outcome
Timeframe: BaselineThe GDS is a brief, self-report involving yes/no questions instrument on psychological aspects and social consequences of depression in the elderly. The short form of GDS of 15-items will be used in this study. Higher scores indicate greater depression (min = 0, max = 15).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Geriatric Depression Scale (GDS)
|
2 points
Standard Deviation 2.19
|
2.42 points
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)The GDS is a brief, self-report involving yes/no questions instrument on psychological aspects and social consequences of depression in the elderly. The short form of GDS of 15-items will be used in this study. Higher scores indicate greater depression (min = 0, max = 15).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Geriatric Depression Scale (GDS)
|
2.24 points
Standard Deviation 2.70
|
2.16 points
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)The GDS is a brief, self-report involving yes/no questions instrument on psychological aspects and social consequences of depression in the elderly. The short form of GDS of 15-items will be used in this study. Higher scores indicate greater depression (min = 0, max = 15).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Geriatric Depression Scale (GDS)
|
2.76 points
Standard Deviation 1.70
|
2.53 points
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: BaselineThe PDQ- 39 is a self-report questionnaire that assesses quality of life over the past month across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Lower scores reflect better quality of life (min = 0, max = 100).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Parkinson's Disease Questionnaire - 39 (PDQ-39)
|
11.95 points
Standard Deviation 8.24
|
14.36 points
Standard Deviation 8.46
|
SECONDARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)The PDQ- 39 is a self-report questionnaire that assesses quality of life over the past month across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Lower scores reflect better quality of life (min = 0, max = 100).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Parkinson's Disease Questionnaire - 39 (PDQ-39)
|
13.57 points
Standard Deviation 8.92
|
15.44 points
Standard Deviation 8.10
|
SECONDARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)The PDQ- 39 is a self-report questionnaire that assesses quality of life over the past month across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life. Lower scores reflect better quality of life (min = 0, max = 100).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Parkinson's Disease Questionnaire - 39 (PDQ-39)
|
12.34 points
Standard Deviation 8.23
|
14.61 points
Standard Deviation 9.23
|
SECONDARY outcome
Timeframe: BaselineThis test comprises of 14 items that span anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function). The total score is reported, calculated as the sum of all items, with possible scores of 0 (lowest level of balance function) and a maximum score of 28 (highest level of balance function).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Mini Balance Evaluation Systems Test (Mini BESTest)
|
24.24 points
Standard Deviation 2.43
|
24.89 points
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Immediately after the intervention (up to 6 weeks)This test comprises of 14 items that span anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function). The total score is reported, calculated as the sum of all items, with possible scores of 0 (lowest level of balance function) and a maximum score of 28 (highest level of balance function).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Mini Balance Evaluation Systems Test (Mini BESTest)
|
24.43 points
Standard Deviation 2.09
|
25.84 points
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)This test comprises of 14 items that span anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0-2 (0 = lowest level of function, 2 = highest level of function). The total score is reported, calculated as the sum of all items, with possible scores of 0 (lowest level of balance function) and a maximum score of 28 (highest level of balance function).
Outcome measures
| Measure |
Amped-PD
n=21 Participants
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=19 Participants
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Mini Balance Evaluation Systems Test (Mini BESTest)
|
24.86 points
Standard Deviation 2.03
|
26.00 points
Standard Deviation 1.53
|
Adverse Events
Amped-PD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Active-Control
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amped-PD
n=21 participants at risk
6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.
Digital music therapeutic: The digital music therapeutic is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.
|
Active-Control
n=20 participants at risk
6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.
Active-Control: The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.
|
|---|---|---|
|
Nervous system disorders
Fall (unrelated)
|
9.5%
2/21 • Number of events 2 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
5.0%
1/20 • Number of events 1 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
|
General disorders
Fall (related)
|
0.00%
0/21 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
10.0%
2/20 • Number of events 2 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Toe pain
|
0.00%
0/21 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
5.0%
1/20 • Number of events 1 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
|
Hepatobiliary disorders
Surgery
|
0.00%
0/21 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
5.0%
1/20 • Number of events 1 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arm pain
|
4.8%
1/21 • Number of events 1 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
0.00%
0/20 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
|
Infections and infestations
Covid-19
|
4.8%
1/21 • Number of events 1 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
0.00%
0/20 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
5.0%
1/20 • Number of events 1 • 8 weeks (includes 6-week intervention and 2-week follow-up)
The 6-week walking program received by both intervention arms incurs negligible risk for all-cause mortality.
|
Additional Information
Franchino Porciuncula, EdD, PT, DScPT
Boston University
Phone: (617) 353-7525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place