A Novel Digital Music-based Autonomous Personalized Walking Intervention to Improve Gait and Walking Automaticity in Parkinson Disease

NCT07705373 | Not Yet Recruiting FDA Device

• 2 other identifiers: 854755213069
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to examine the effects of a 3-month personalized community-based walking program called MyMusiQ. The study uses music cues delivered through a digital device in people with Parkinson disease (PD). The investigators want to know if personalized music cueing through the digital device can improve walking quality, walking ability, daily walking amount and intensity, and quality of life, while helping walking feel more automatic and require less mental effort. Participants will take part in this research study for approximately 18 weeks in total. During this time, participants will complete 4 study visits at designated research centers at Boston University, Washington University in St. Louis, or the University of Utah, depending on the site of enrollment.

Conditions

Parkinson's Disease (PD)

Keywords

Music-based intervention; Gait quality; Walking capacity; Gait automaticity; Parkinson's Disease (PD)

Outcome Measures

Primary Outcomes (24)

• Minutes of Moderate Intensity Walking

  The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min, measured using research-grade wearable sensors.

  Baseline 1

• Minutes of Moderate Intensity Walking

  The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min, measured using research-grade wearable sensors.

  Baseline 2 (2-3 weeks after Baseline 1)

• Minutes of Moderate Intensity Walking

  The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min, measured using research-grade wearable sensors.

  Immediately after the intervention (about 3 months)

• Minutes of Moderate Intensity Walking

  The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min, measured using research-grade wearable sensors.

  Follow-Up (about 1 month post-intervention)

• Daily Step Counts

  Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.

  Baseline 1

• Daily Step Counts

  Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.

  Baseline 2 (2-3 weeks after Baseline 1)

• Daily Step Counts

  Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.

  Immediately after the intervention (about 3 months)

• Daily Step Counts

  Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.

  Follow-Up (about 1 month post-intervention)

• 6-Minute Walk Test

  This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.

  Baseline 1

• 6-Minute Walk Test

  This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.

  Baseline 2 (2-3 weeks after Baseline 1)

• 6-Minute Walk Test

  This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.

  Immediately after the intervention (about 3 months)

• 6-Minute Walk Test

  This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.

  Follow-Up (about 1 month post-intervention)

• Gait Speed

  Gait speed (m/s) will be measured using research-grade wearable sensors.

  Baseline 1

• Gait Speed

  Gait speed (m/s) will be measured using research-grade wearable sensors.

  Baseline 2 (2-3 weeks after Baseline 1)

• Gait Speed

  Gait speed (m/s) will be measured using research-grade wearable sensors.

  Immediately after the intervention (about 3 months)

• Gait Speed

  Gait speed (m/s) will be measured using research-grade wearable sensors.

  Follow-Up (about 1 month post-intervention)

• Stride Length

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

  Baseline 1

• Stride Length

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

  Baseline 2 (2-3 weeks after Baseline 1)

• Stride Length

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

  Immediately after the intervention (about 3 months)

• Stride Length

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

  Follow-Up (about 1 month post-intervention)

• Variability of Stride Time

  Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade 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 a percentage.

  Baseline 1

• Variability of Stride Time

  Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade 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 a percentage.

  Baseline 2 (2-3 weeks after Baseline 1)

• Variability of Stride Time

  Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade 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 a percentage.

  Immediately after the intervention (about 3 months)

• Variability of Stride Time

  Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade 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 a percentage.

  Follow-Up (about 1 month post-intervention)

Secondary Outcomes (75)

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

  Baseline 1

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

  Baseline 2 (2-3 weeks after Baseline 1)

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

  Immediately after the intervention (about 3 months)

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

  Follow-Up (about 1 month post-intervention)

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

  Baseline 1

Study Arms (1)

MyMusiQ (MMQ) Walking intervention

EXPERIMENTAL

12-week self-directed, home/community-based walking intervention that leverages the benefits of rhythmic auditory stimulation via a digital music device (MedRhythms, Inc., Portland, ME) in improving walking outcomes in persons with PD.

Device: Digital Music Device (MedRhythms, Inc., Portland, ME)

Interventions

Digital Music Device (MedRhythms, Inc., Portland, ME) DEVICE

The digital music device 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.

MyMusiQ (MMQ) Walking intervention

Eligibility Criteria

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

You may qualify if:

• Self-report of diagnosis of typical Parkinson disease determined by a medical doctor
• ≥ 40 years of age
• Community-dwelling (e.g. home, independent living, senior housing)
• Have stable PD medications for at least two weeks prior to enrollment
• Modified Hoehn and Yahr stages 1-3 per physical exam by a licensed physical therapist
• Able to walk independently without physical assistance for at least 10 minutes (assistive devices allowed with reciprocal gait pattern)
• 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
• Significantly disturbing freezing episodes during daily walking based on the New Freezing of Gait Questionnaire (Part III Item 7)
• Fall frequencies \>1x/week on average, over the past month.
• Currently participating in physical therapy for Parkinson gait rehabilitation
• Currently performing walking exercise at moderate intensities or higher for at least 30 min. per session ≥ 3x/week
• Self-reported cardiac problems that interfere with the ability to safely exercise (e.g., congestive heart failure, uncontrolled cardiac arrhythmias, chest pain;
• Orthopedic problems in the lower extremities or spine that may limit walking distance (e.g., severe arthritis, spinal stenosis, or significant pain)
• Any other medical conditions that would preclude successful participation as determined by the researcher/ physical therapist
• Cognitive impairment (i.e., Montreal Cognitive Assessment, MoCA \< 21)
• Unable to walk independently (i.e., without physical assistance) at a comfortable speed ≥ 0.4m/s as measured using the 10-meter Walk Test (10mWT) as examined in Baseline #1
• Resting tachycardia (\> 100 beats/min) or uncontrolled blood pressure (resting systolic BP \> 160 mmHg or diastolic BP \>100 mmHg)) as measured by the researcher/ physical therapist
• Unable to independently use the music-based digital therapeutic during training
• Significant hearing impairment

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• University of Utah: collaborator
• Washington University School of Medicine: collaborator

Study Sites (3)

Boston University Center for Neurorehabilitation

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (3)

• Zajac JA, Porciuncula F, Cavanaugh JT, McGregor C, Harris BA, Smayda KE, Awad LN, Pantelyat A, Ellis TD. Feasibility and Proof-of-Concept of Delivering an Autonomous Music-Based Digital Walking Intervention to Persons with Parkinson's Disease in a Naturalistic Setting. J Parkinsons Dis. 2023;13(7):1253-1265. doi: 10.3233/JPD-230169.

  PMID: 37840504 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Terry D. Ellis, PhD, PT

  Boston University Center for Neurorehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Clarke, BS

CONTACT

617-358-6157; egclarke@bu.edu

Franchino Porciuncula, EdD, PT, DScPT

CONTACT

617-353-7571; fporciun@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: Data relevant to eventual publication may be made available within reasonable request. Other datasets generated from the study may be accessed through requests in compliance with the study funder's protocol.

Locations

US (3)