Amped-PD: Amplifying Physical Activity Through Music in Parkinson Disease

Sponsor

Boston University Charles River Campus (Other)

Overall Status

Recruiting

CT.gov ID

NCT05421624

Collaborator

University of New England (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Regular, habitual exercise is a critical component of the long-term management of Parkinson disease (PD). However, PD-specific motor (e.g. slow and diminished movements, variable step timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical activity. Rhythmic auditory stimulation (RAS) is a rehabilitation technique that employs coupling of auditory cues with movement. Walking with RAS has been shown to benefit walking rhythmicity, quality, and speed. These walking benefits make RAS advantageous in promoting moderate intensity walking activity -- an important health-objective in the management of PD. However, the therapeutic potential of RAS in self-directed walking programs has not been examined. In this pilot, we will utilize a breakthrough digital therapeutic that delivers music-adaptive RAS to alleviate PD-specific problems by regulating stepping patterns. Using music as a substrate for cue delivery, this digital therapeutic leverages gait benefits from RAS along with enjoyment of music listening, thus making it a viable and engaging modality that will yield habits of regular walking. Habits are automatically recurring psychological dispositions that emerge from repeated behaviors. The investigators posit that music cues provide recurring contextual cues that automatically evoke habitual response of exercise, thus has the potential to prompt regular physical activity. This study will enroll 44 individuals with mild-to-moderate PD. The experimental intervention, "Amped-PD", is a 6-week, user-managed community-based walking program that utilizes music-adaptive RAS that progressively increases walking intensities. This study will examine if Amped-PD (Experimental Intervention) is more effective than a standard-of-care walking program (Active-Control Intervention) in improving physical activity based on moderate intensity walking, and in improving motor deficits related to quality of walking in individuals with mild-to-moderate PD. This study will also examine whether the resultant habits formed from each intervention matter in relation to training-related changes in physical activity.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: Digital music therapeutic Behavioral: Active-Control	N/A

Detailed Description

Parkinson disease (PD) is the fastest growing source of disability among neurological disorders. Diminished physical activity is highly prevalent in PD and often lead to the onset of disability. Regular, habitual exercise is a critical component of the long-term PD management. However, PD-specific motor (e.g. slow and diminished movements, variable step timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical activity. Rhythmic auditory stimulation (RAS) is a rehabilitation technique that employs the coupling of auditory cues with movement. When used during walking, RAS has been shown to benefit walking rhythmicity, quality, and speed. Therefore this rehabilitation technique can be advantageous in promoting moderate intensity walking activity. While clinical studies support RAS-based intervention, its translation to real-world, community-based environments and for long-term exercise for the promotion of physical activity is limited. The difference that determines viability of RAS for out-of-lab applications lie in the distinction between external entrainment (open-loop) versus autonomous entrainment (closed-loop). Open-loop RAS requires high levels of vigilance and is prone to error accumulation, which is problematic with gait dysfunction in PD. On the other hand, closed-loop RAS allows for natural and stable entrainment. A closed-loop approach in this case is a necessity of the task and a technological challenge to translate RAS to community-based settings. In this pilot, the investigators will utilize a breakthrough digital therapeutic that employs closed-loop RAS to alleviate PD-specific problems by regulating stepping patterns. Using music as a substrate for cue delivery, this digital therapeutic leverages gait benefits from RAS along with enjoyment of music listening, thus making it a viable and engaging modality that will yield habits of regular walking. The investigators posit that music that is linked to enjoyment serves as context cues that define the pre-condition to engaging in habitual walking exercise and increased physical activity. With repetition, these recurring contextual triggers (i.e. music) automatically evoke a habitual response of exercise, and thus has the potential to amplify physical activity.

The main aims of the study seek to examine if Amped-PD (Experimental Intervention) is more effective than a standard-of-care walking program (Active-Control Intervention) in improving physical activity based on moderate intensity walking (Aim 1), and in improving motor deficits related to quality of walking (Aim 2) in individuals with mild-to-moderate PD. Additionally, this study will examine whether habit formation mediates the relationship between the intervention (Amped-PD or Active-Control) and physical activity (Aim 3). The investigators hypothesize that Amped-PD will have greater improvements in amounts of moderate intensity walking and stride-to-stride variability based on stride length and swing time. Further, habit formation will be one mechanism that will explain the link between the intervention and physical activity. Secondary research aims will examine whether Amped-PD is more effective than Active-Control in improving motor and non-motor features based on short- and long-distance walking function, spatiotemporal measures of walking, step activity based on daily step counts, disease severity scores, quality of life, self-efficacy on walking, and depression.

This study will utilize the breakthrough digital music therapeutic developed and manufactured by MedRhythms (Portland, ME). To examine the effects of the intervention, the investigators will use clinical measures of motor and gait function, participant self-reports on habit formation, and quantified movement data on walking and physical activity using wearable sensors. This study will be implemented by carrying out the following study visits: (1) Primary screen over the phone, (2) Clinical Screening and Baseline Assessment, (3) Community-based, self-directed walking program (6 weeks), (3) Post-training Assessment; (4) Follow-up training (2 weeks), and (5) Final Follow-Up Assessment. Altogether, these procedures may take up to 10 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are randomly assigned to either intervention of (1) Amped-PD, or (2) Active-Control.Participants are randomly assigned to either intervention of (1) Amped-PD, or (2) Active-Control.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Amped-PD: Amplifying Physical Activity Through a Novel Digital Music Therapeutic in Parkinson Disease

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Amped-PD 6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.	Device: 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. Other Names: MedRhythms device
Active Comparator: Active-Control 6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Amped-PD

6-week community-based, self-directed walking program that uses a novel digital therapeutic that delivers music-adaptive rhythmic auditory stimulation.

Device: 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.

Other Names:

MedRhythms device

Active Comparator: Active-Control

6-week community-based, self-directed walking program without using a novel digital therapeutic or any form of rhythmic auditory stimulation.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Physical activity based on the amount of moderate intensity walking [Baseline]
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.
Physical activity based on the amount of moderate intensity walking [During training up to 4 days from start of training]
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.
Physical activity based on the amount of moderate intensity walking [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.
Physical activity based on the amount of moderate intensity walking [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.
Gait quality based on variability of stride length [Baseline]
Stride-to-stride variability of stride lengthof the gait cycle will be measured using wearable sensors.
Gait quality based on variability of stride length [Immediately after the intervention (up to 6 weeks)]
Stride-to-stride variability of stride length of the gait cycle will be measured using wearable sensors.
Gait quality based on variability of stride length [Follow-up (up to 2 weeks post-intervention)]
Stride-to-stride variability of stride length of the gait cycle will be measured using wearable sensors.
Gait quality based on variability of swing time [Baseline]
Stride-to-stride variability of swing time subphase of the gait cycle will be measured using wearable sensors.
Gait quality based on variability of swing time [Immediately after the intervention (up to 6 weeks)]
Stride-to-stride variability of swing time subphase of the gait cycle will be measured using wearable sensors.
Gait quality based on variability of swing time [Follow-up (up to 2 weeks post-intervention)]
Stride-to-stride variability of swing time subphase of the gait cycle will be measured using wearable sensors.
Self-Report Behavioral Automaticity Index (SRBAI) [Baseline]
The Self-Report Behavioral Automaticity Index (SRBAI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit automaticity. 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). Select items from this test make up the Self-Report Habit Index, which examines strength and automaticity of habits.
Self-Report Behavioral Automaticity Index (SRBAI) [Immediately after the intervention (up to 6 weeks)]
The Self-Report Behavioral Automaticity Index (SRBAI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit automaticity. 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). Select items from this test make up the Self-Report Habit Index, which examines strength and automaticity of habits.
Self-Report Behavioral Automaticity Index (SRBAI) [Follow-up (up to 2 weeks post-intervention)]
The Self-Report Behavioral Automaticity Index (SRBAI) will be used to assess habit formation. This index is a patient-reported outcome that examines habit automaticity. 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). Select items from this test make up the Self-Report Habit Index, which examines strength and automaticity of habits.

Secondary Outcome Measures

10-Meter Walk Test (10MWT) [Baseline]
This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.
10-Meter Walk Test (10MWT) [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) and maximum walking speed (MWS) on a ten-meter straight walkway.
10-Meter Walk Test (10MWT) [Follow-up (up to 2 weeks post-intervention)]
This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.
6-Minute Walk Test (6MWT) [Baseline]
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.
6-Minute Walk Test (6MWT) [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.
6-Minute Walk Test (6MWT) [Follow-up (up to 2 weeks post-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.
Walking cadence during in-clinic walking [Baseline]
Quantified metrics of walking cadence (steps/min) will be collected using wearable sensors.
Walking cadence during in-clinic walking [Immediately after the intervention (up to 6 weeks)]
Quantified metrics of walking cadence (steps/min) will be collected using wearable sensors.
Walking cadence during in-clinic walking [Follow-up (up to 2 weeks post-intervention)]
Quantified metrics of walking cadence (steps/min) will be collected using wearable sensors.
Gait velocity during in-clinic walking [Baseline]
Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Gait velocity during in-clinic walking [Immediately after the intervention (up to 6 weeks)]
Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Gait velocity during in-clinic walking [Follow-up (up to 2 weeks post-intervention)]
Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.
Stride length during in-clinic walking [Baseline]
Quantified metrics of stride length (m) will be collected using wearable sensors.
Stride length during in-clinic walking [Immediately after the intervention (up to 6 weeks)]
Quantified metrics of stride length (m) will be collected using wearable sensors.
Stride length during in-clinic walking [Follow-up (up to 2 weeks post-intervention)]
Quantified metrics of stride length (m) will be collected using wearable sensors.
Step activity based on daily step counts [Baseline]
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.
Step activity based on daily step counts [During training up to 4 days from start of training]
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.
Step activity based on daily step counts [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.
Step activity based on daily step counts [Follow-up (up to 2 weeks post-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.
Movement Disorder Society Unified Parkinson Disease Rating Scale motor subsection (MDS-UPDRS III) [Baseline]
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. Total scores can range from 0 to 141, with higher scores indicating worse disease severity.
Movement Disorder Society Unified Parkinson Disease Rating Scale motor subsection (MDS-UPDRS III) [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. Total scores can range from 0 to 141, with higher scores indicating worse disease severity.
Movement Disorder Society Unified Parkinson Disease Rating Scale motor subsection (MDS-UPDRS III) [Follow-up (up to 2 weeks post-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. Total scores can range from 0 to 141, with higher scores indicating worse disease severity.
Quality of Life in Neurological Disorders (Neuro-QoL) [Baseline]
The Neuro-QOL is a multi-dimensional patient self-report outcome that spans physical, mental, and social health aspects. The Neuro-QOL will be administered to measure and monitor quality of life. Higher score means higher quality of life (Min = 97, Max = 290)
Quality of Life in Neurological Disorders (Neuro-QoL) [Immediately after the intervention (up to 6 weeks)]
The Neuro-QOL is a multi-dimensional patient self-report outcome that spans physical, mental, and social health aspects. The Neuro-QOL will be administered to measure and monitor quality of life. Higher score means higher quality of life (Min = 97, Max = 290)
Quality of Life in Neurological Disorders (Neuro-QoL) [Follow-up (up to 2 weeks post-intervention)]
The Neuro-QOL is a multi-dimensional patient self-report outcome that spans physical, mental, and social health aspects. The Neuro-QOL will be administered to measure and monitor quality of life. Higher score means higher quality of life (Min = 97, Max = 290)
Self-Efficacy of Walking - Duration (SEW-D) [Baseline]
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).
Self-Efficacy of Walking - Duration (SEW-D) [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).
Self-Efficacy of Walking - Duration (SEW-D) [Follow-up (up to 2 weeks post-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).
Geriatric Depression Scale (GDS) [Baseline]
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).
Geriatric Depression Scale (GDS) [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).
Geriatric Depression Scale (GDS) [Follow-up (up to 2 weeks post-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).
Parkinson's Disease Questionnaire - 39 (PDQ-39) [Baseline]
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).
Parkinson's Disease Questionnaire - 39 (PDQ-39) [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).
Parkinson's Disease Questionnaire - 39 (PDQ-39) [Follow-up (up to 2 weeks post-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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of idiopathic, typical Parkinson disease (based on the UK PD Society Brain Bank Criteria7) by a physician
Modified Hoehn and Yahr stages 1-3 per physical exam by a licensed physical therapist
40 - 80 years of age
Community-dwelling
Able to walk independently without physical assistance or an assistive device for at least 10 minutes.
Have stable PD medications for at least two weeks prior to enrollment.
Willing and able to provide informed consent.
Provide HIPAA Authorization to allow communication with the primary healthcare provider for communication (as needed) during the study period.

Exclusion Criteria:

< 40 years of age
Diagnosis of atypical Parkinsonism
Modified Hoehn and Yahr stages 4-5
Moderately or significantly disturbing freezing episodes during daily walking based on the New Freezing of Gait Questionnaire
History of >1 fall over the past 3 months
Cognitive impairment (i.e., Mini-Mental State Exam Score (MMSE) < 24)
Unable to walk independently (i.e. without physical assistance or assistive device) at a comfortable speed of 0.4m/s or greater (i.e., 10-meter Walk Test (10mWT))
Unable to independently use the music-based digital therapeutic during training
Significant hearing impairment
Currently participating in physical therapy
Currently performing regular walking exercise > 3x/week for 30 minutes per session.
Cardiac conditions that may limit safe participation in exercise
Orthopedic conditions that may limit safe participation in exercise
Any other medical conditions that would preclude successful participation as determined by a physical therapist