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Completed

NCT Number: NCT05421624

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

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 61individuals with mild-to-moderate PD (Run-in: 17; Main Trial: 44). 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Habits Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Neurorehabilitation at Boston University

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 - 85 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

Treatment and study plan

Digital music therapeutic

Device

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-Control

Behavioral

The Active-Control intervention will implement a similarly structured community-based walking program as Amped-PD, with the only exception the digital music therapeutic.

Primary outcomes

  1. Physical Activity Based on the Amount of Moderate Intensity Walking

    Time frame: 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.

  2. Physical Activity Based on the Amount of Moderate Intensity Walking

    Time frame: 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.

  3. Physical Activity Based on the Amount of Moderate Intensity Walking

    Time frame: 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.

  4. Physical Activity Based on the Amount of Moderate Intensity Walking

    Time frame: 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.

  5. Step Activity Based on Daily Step Counts

    Time frame: 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.

  6. Step Activity Based on Daily Step Counts

    Time frame: 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.

  7. Step Activity Based on Daily Step Counts

    Time frame: 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.

  8. Step Activity Based on Daily Step Counts

    Time frame: 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.

  9. Gait Quality Based on Variability of Stride Time

    Time frame: Baseline

    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.

  10. Gait Quality Based on Variability of Stride Time

    Time frame: 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.

  11. Gait Quality Based on Variability of Stride Time

    Time frame: 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.

  12. Self-Report Habit Index (SRHI)

    Time frame: Baseline

    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).

  13. Self-Report Habit Index (SRHI)

    Time frame: 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).

Secondary outcomes

  1. 10-Meter Walk Test (10MWT) - Comfortable Walking Speed

    Time frame: Baseline

    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.

  2. 10-Meter Walk Test (10MWT) - Comfortable Walking Speed

    Time frame: 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.

  3. 10-Meter Walk Test (10MWT) - Comfortable Walking Speed

    Time frame: 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.

  4. 10-Meter Walk Test (10MWT) - Maximum Walking Speed

    Time frame: Baseline

    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.

  5. 10-Meter Walk Test (10MWT) - Maximum Walking Speed

    Time frame: 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.

  6. 10-Meter Walk Test (10MWT) - Maximum Walking Speed

    Time frame: 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.

  7. 6-Minute Walk Test (6MWT)

    Time frame: 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.

  8. 6-Minute Walk Test (6MWT)

    Time frame: 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.

  9. 6-Minute Walk Test (6MWT)

    Time frame: 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.

  10. Gait Velocity During In-clinic Walking

    Time frame: Baseline

    Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.

  11. Gait Velocity During In-clinic Walking

    Time frame: Immediately after the intervention (up to 6 weeks)

    Quantified metrics of walking velocity (m/s) will be collected using wearable sensors.

  12. Gait Velocity During In-clinic Walking

    Time frame: 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.

  13. Stride Length During In-clinic Walking

    Time frame: Baseline

    Quantified metrics of stride length (m) will be collected using wearable sensors.

  14. Stride Length During In-clinic Walking

    Time frame: Immediately after the intervention (up to 6 weeks)

    Quantified metrics of stride length (m) will be collected using wearable sensors.

  15. Stride Length During In-clinic Walking

    Time frame: Follow-up (up to 2 weeks post-intervention)

    Quantified metrics of stride length (m) will be collected using wearable sensors.

  16. Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)

    Time frame: 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. The total score is reported, which can range from 0 (no impairment) to 141 (maximum impairment).

  17. Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)

    Time frame: 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).

  18. Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS III)

    Time frame: 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).

  19. Self-Efficacy of Walking - Duration (SEW-D)

    Time frame: 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).

  20. Self-Efficacy of Walking - Duration (SEW-D)

    Time frame: 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).

  21. Self-Efficacy of Walking - Duration (SEW-D)

    Time frame: 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).

  22. Geriatric Depression Scale (GDS)

    Time frame: 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).

  23. Geriatric Depression Scale (GDS)

    Time frame: 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).

  24. Geriatric Depression Scale (GDS)

    Time frame: 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).

  25. Parkinson's Disease Questionnaire - 39 (PDQ-39)

    Time frame: 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).

  26. Parkinson's Disease Questionnaire - 39 (PDQ-39)

    Time frame: 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).

  27. Parkinson's Disease Questionnaire - 39 (PDQ-39)

    Time frame: 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).

  28. Mini Balance Evaluation Systems Test (Mini BESTest)

    Time frame: Baseline

    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).

  29. Mini Balance Evaluation Systems Test (Mini BESTest)

    Time frame: 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).

  30. Mini Balance Evaluation Systems Test (Mini BESTest)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • National Institute on Aging (NIA)
  • University of New England

Registry information

Official study title

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

Acronym: Amped-PD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2022
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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