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

NCT05421624 | Completed Results FDA Device

• 2 other identifiers: 6518P30AG048785
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; rhythmic auditory stimulation; digital therapeutics; behavior change; habits; physical activity

Outcome Measures

Primary Outcomes (13)

• Physical Activity Based on the Amount of Moderate Intensity Walking

  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.

  Baseline

• Physical Activity Based on the Amount of Moderate Intensity Walking

  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.

  During training up to 4 days from start of training

• Physical Activity Based on the Amount of Moderate Intensity Walking

  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.

  Immediately after the intervention (up to 6 weeks)

• Physical Activity Based on the Amount of Moderate Intensity Walking

  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.

  Follow-up (up to 2 weeks post-intervention)

• Step Activity Based on Daily Step Counts

  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.

  Baseline

• Step Activity Based on Daily Step Counts

  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.

  During training up to 4 days from start of training

• Step Activity Based on Daily Step Counts

  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.

  Immediately after the intervention (up to 6 weeks)

• Step Activity Based on Daily Step Counts

  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.

  Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)

• Gait Quality Based on Variability of Stride Time

  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.

  Baseline

• Gait Quality Based on Variability of Stride Time

  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.

  Immediately after the intervention (up to 6 weeks)

• Gait Quality Based on Variability of Stride Time

  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.

  Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)

• Self-Report Habit Index (SRHI)

  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).

  Baseline

• Self-Report Habit Index (SRHI)

  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).

  Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)

Secondary Outcomes (30)

• 10-Meter Walk Test (10MWT) - Comfortable Walking Speed

  Baseline

• 10-Meter Walk Test (10MWT) - Comfortable Walking Speed

  Immediately after the intervention (up to 6 weeks)

• 10-Meter Walk Test (10MWT) - Comfortable Walking Speed

  Follow-up (up to 2 weeks post-intervention completion, and up to 8 weeks from baseline/start of intervention)

• 10-Meter Walk Test (10MWT) - Maximum Walking Speed

  Baseline

• 10-Meter Walk Test (10MWT) - Maximum Walking Speed

  Immediately after the intervention (up to 6 weeks)

Study Arms (2)

Amped-PD

EXPERIMENTAL

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

Active-Control

ACTIVE COMPARATOR

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

Behavioral: Active-Control

Interventions

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.

Also known as: MedRhythms device

Amped-PD

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.

Active-Control

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• University of New England: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Center for Neurorehabilitation at Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (12)

• Cavanaugh JT, Ellis TD, Earhart GM, Ford MP, Foreman KB, Dibble LE. Toward Understanding Ambulatory Activity Decline in Parkinson Disease. Phys Ther. 2015 Aug;95(8):1142-50. doi: 10.2522/ptj.20140498. Epub 2015 Apr 9.

  PMID: 25858971 BACKGROUND

• Ellis TD, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Thackeray A, Thiese MS, Dibble LE. Identifying clinical measures that most accurately reflect the progression of disability in Parkinson disease. Parkinsonism Relat Disord. 2016 Apr;25:65-71. doi: 10.1016/j.parkreldis.2016.02.006. Epub 2016 Feb 2.

  PMID: 26876037 BACKGROUND

• Nombela C, Hughes LE, Owen AM, Grahn JA. Into the groove: can rhythm influence Parkinson's disease? Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2564-70. doi: 10.1016/j.neubiorev.2013.08.003. Epub 2013 Sep 3.

  PMID: 24012774 BACKGROUND

• Thaut MH, McIntosh GC, Rice RR, Miller RA, Rathbun J, Brault JM. Rhythmic auditory stimulation in gait training for Parkinson's disease patients. Mov Disord. 1996 Mar;11(2):193-200. doi: 10.1002/mds.870110213.

  PMID: 8684391 BACKGROUND

• 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.

  PMID: 33040685 BACKGROUND

• Gardner B. A review and analysis of the use of 'habit' in understanding, predicting and influencing health-related behaviour. Health Psychol Rev. 2015;9(3):277-95. doi: 10.1080/17437199.2013.876238. Epub 2014 Jan 21.

  PMID: 25207647 BACKGROUND

• Galla BM, Duckworth AL. More than resisting temptation: Beneficial habits mediate the relationship between self-control and positive life outcomes. J Pers Soc Psychol. 2015 Sep;109(3):508-25. doi: 10.1037/pspp0000026. Epub 2015 Feb 2.

  PMID: 25643222 BACKGROUND

• 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.

  PMID: 32083083 BACKGROUND

• 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.

  PMID: 32255504 BACKGROUND

• 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.

  PMID: 21798044 BACKGROUND

• 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.

  PMID: 40438970 DERIVED

• 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.

  PMID: 40301366 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Habits; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Results Point of Contact

• Title: Franchino Porciuncula, EdD, PT, DScPT
• Organization: Boston University

fporciun@bu.edu

(617) 353-7525

Study Officials

• Franchino Porciuncula, PT, EdD

  Boston University

  PRINCIPAL INVESTIGATOR

• Terry D. Ellis, PT, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 16, 2022
• Study Start: August 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 31, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)