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

NCT ID: NCT05421624

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-11-01

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 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.

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Amped-PD

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

Group Type: EXPERIMENTAL

Digital music therapeutic

Intervention Type: 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.

Active-Control

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

Group Type: ACTIVE_COMPARATOR

Active-Control

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MedRhythms device

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of New England

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franchino Porciuncula, PT, EdD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Terry D. Ellis, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Center for Neurorehabilitation at Boston University

Boston, Massachusetts, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 25858971 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 8684391 (View on PubMed)

Hutchinson K, Sloutsky R, Collimore A, Adams B, Harris B, Ellis TD, Awad LN. A Music-Based Digital Therapeutic: Proof-of-Concept Automation of a Progressive and Individualized Rhythm-Based Walking Training Program After Stroke. Neurorehabil Neural Repair. 2020 Nov;34(11):986-996. doi: 10.1177/1545968320961114. Epub 2020 Oct 10.

Reference Type: BACKGROUND

PMID: 33040685 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Wittwer JE, Winbolt M, Morris ME. Home-Based Gait Training Using Rhythmic Auditory Cues in Alzheimer's Disease: Feasibility and Outcomes. Front Med (Lausanne). 2020 Jan 31;6:335. doi: 10.3389/fmed.2019.00335. eCollection 2019.

Reference Type: BACKGROUND

PMID: 32083083 (View on PubMed)

Jeng B, Cederberg KL, Lai B, Sasaki JE, Bamman MM, Motl RW. Step-rate threshold for physical activity intensity in Parkinson's disease. Acta Neurol Scand. 2020 Aug;142(2):145-150. doi: 10.1111/ane.13250. Epub 2020 Apr 22.

Reference Type: BACKGROUND

PMID: 32255504 (View on PubMed)

Tudor-Locke C, Craig CL, Aoyagi Y, Bell RC, Croteau KA, De Bourdeaudhuij I, Ewald B, Gardner AW, Hatano Y, Lutes LD, Matsudo SM, Ramirez-Marrero FA, Rogers LQ, Rowe DA, Schmidt MD, Tully MA, Blair SN. How many steps/day are enough? For older adults and special populations. Int J Behav Nutr Phys Act. 2011 Jul 28;8:80. doi: 10.1186/1479-5868-8-80.

Reference Type: BACKGROUND

PMID: 21798044 (View on PubMed)

Cavanaugh JT, Porciuncula F, Zajac JA, Baker T, Wendel N, Awad LN, Ellis TD. Gait Responses in People with Parkinson Disease During Autonomous Closed-loop Rhythmic Auditory Stimulation: An Exploratory Analysis. Neurorehabil Neural Repair. 2025 Aug;39(8):666-676. doi: 10.1177/15459683251340910. Epub 2025 May 29.

Reference Type: DERIVED

PMID: 40438970 (View on PubMed)

Porciuncula F, Cavanaugh JT, Zajac J, Wendel N, Baker T, Arumukhom Revi D, Eklund N, Holmes MB, Awad LN, Ellis TD. Amplifying walking activity in Parkinson's disease through autonomous music-based rhythmic auditory stimulation: randomized controlled trial. NPJ Parkinsons Dis. 2025 Apr 29;11(1):100. doi: 10.1038/s41531-025-00952-x.

Reference Type: DERIVED

PMID: 40301366 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30AG048785

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6518

Identifier Type: -

Identifier Source: org_study_id