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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease (PD)
• Intervention / Treatment: Device: Digital Music Device (MedRhythms, Inc., Portland, ME)

Detailed Description

The overall goal of this 3-month single-arm multi-center repeated baselines study (N=162) is to examine the effects of a personalized closed-loop music-based digital gait intervention on improving gait quality, capacity, real-world walking performance, and gait automaticity in Parkinson disease (PD). This study builds on a stepwise investigation beginning with a proof-of-concept feasibility study (N=23) followed by a 6-week randomized controlled trial (RCT; N=44). This mechanistic-focused study will examine the substrates of a personalized approach that underlie changes in walking outcomes, as well as identify determinants that determine responsiveness to the intervention. This study is a critical next step to elucidate mechanistic understanding of closed-loop personalized gait approaches and to determine those with PD who benefit most.

The main aims of this mechanistic study seek to examine whether a personalized closed-loop gait intervention improves gait quality, walking capacity, and real-world walking performance beyond baseline variability, and to assess how personalized features influence targeted gait outcomes (Aim 1). Additionally, this study will investigate the effects of the intervention on improving gait automaticity (Aim 2), and identify baseline determinants that predict responsiveness and durability to the intervention on walking capacity (Aim 3). The investigators hypothesize that the intervention will meaningfully improve gait quality (speed, stride length), walking capacity (6-Minute Walk Test), and real-world walking performance (walking intensity and amount) during cued and uncued walking during and after intervention. Furthermore, they hypothesize improvements in gait automaticity (reduced gait variability, dual-tasking costs) following the intervention, and that individuals with worse baseline cognitive-motor capacities may benefit more.

This study will utilize a digital music device (MedRhythms, Inc., Portland, ME). To examine the effects of the intervention, the investigators will use clinical measures of motor and gait function, and quantified movement data on walking using wearable sensors. This study will be implemented by carrying out the following study visits: (1) Primary screen over the phone, (2) In-Person Screening and Baseline Assessment #1, (3) Baseline Assessment #2 (2-3 weeks after Baseline Assessment #1) (4) Personalized, Closed-Loop Music-Based Gait Intervention (3 months) (5) Post-Intervention Assessment (immediately after the intervention, about 3 months), and (6) Durability / Follow-Up Assessment (about 1 month post-intervention). Altogether, these procedures may take about 4 months.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erica Clarke, BS; Phone Number: 617-358-6157; Email: egclarke@bu.edu
• Study Contact Backup: Name: Franchino Porciuncula, EdD, PT, DScPT; Phone Number: 617-353-7571; Email: fporciun@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University Center for Neurorehabilitation
      • Contact: Erica Clarke, BS; Phone Number: 617-358-6157; Email: egclarke@bu.edu
      • Principal Investigator: Terry D. Ellis, PhD, PT
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
      • Contact: Kayla Bell, PT, DPT; Phone Number: 314-273-6016; Email: kayla.bell@wustl.edu
      • Contact: Kerri Rawson, PhD, MS; Phone Number: 813-468-8900; Email: rawson@wustl.edu
      • Principal Investigator: Gammon Earhart, PT, PhD
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah
      • Contact: Rheanna Anderson, MS; Phone Number: 801-587-3615; Email: rheanna.anderson@utah.edu
      • Principal Investigator: Lee Dibble, PT, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• < 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MyMusiQ (MMQ) Walking intervention; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-Meter Walk Test (10MWT) - Comfortable Walking Speed	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.	Baseline 1
10-Meter Walk Test (10MWT) - Comfortable Walking Speed	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.	Baseline 2 (2-3 weeks after Baseline 1)
10-Meter Walk Test (10MWT) - Comfortable Walking Speed	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.	Immediately after the intervention (about 3 months)
10-Meter Walk Test (10MWT) - Comfortable Walking Speed	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.	Follow-Up (about 1 month post-intervention)
10-Meter Walk Test (10MWT) - Fast Walking Speed	This is a test of short-distance walking function. The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.	Baseline 1
10-Meter Walk Test (10MWT) - Fast Walking Speed	This is a test of short-distance walking function. The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.	Baseline 2 (2-3 weeks after Baseline 1)
10-Meter Walk Test (10MWT) - Fast Walking Speed	This is a test of short-distance walking function. The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.	Immediately after the intervention (about 3 months)
10-Meter Walk Test (10MWT) - Fast Walking Speed	This is a test of short-distance walking function. The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.	Follow-Up (about 1 month post-intervention)
Five Times Sit-to-Stand	This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.	Baseline 1
Five Times Sit-to-Stand	This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.	Baseline 2 (2-3 weeks after Baseline 1)
Five Times Sit-to-Stand	This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.	Immediately after the intervention (about 3 months)
Five Times Sit-to-Stand	This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.	Follow-Up (about 1 month post-intervention)
Generic Walking Scale (Walk-12G)	This test is a self-report questionnaire that measures everyday walking difficulties. Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.	Baseline 1
Generic Walking Scale (Walk-12G)	This test is a self-report questionnaire that measures everyday walking difficulties. Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.	Baseline 2 (2-3 weeks after Baseline 1)
Generic Walking Scale (Walk-12G)	This test is a self-report questionnaire that measures everyday walking difficulties. Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.	Immediately after the intervention (about 3 months)
Generic Walking Scale (Walk-12G)	This test is a self-report questionnaire that measures everyday walking difficulties. Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.	Follow-Up (about 1 month post-intervention)
Global Rating of Change (GROC) Scale	This self-reported rating scale measures overall perceived improvement in areas related to amount of walking, intensity of walking, and walking capacity. Scores range from -7 to +7, with higher scores indicating greater improvement.	Immediately after the intervention (about 3 months)
Mini Balance Evaluation Systems Test (Mini-BESTest)	This test is a clinical balance assessment tool designed to examine various elements of balance control. Scores range from 0 to 28, with higher scores indicating better balance.	Baseline 1
Mini Balance Evaluation Systems Test (Mini-BESTest)	This test is a clinical balance assessment tool designed to examine various elements of balance control. Scores range from 0 to 28, with higher scores indicating better balance.	Baseline 2 (2-3 weeks after Baseline 1)
Mini Balance Evaluation Systems Test (Mini-BESTest)	This test is a clinical balance assessment tool designed to examine various elements of balance control. Scores range from 0 to 28, with higher scores indicating better balance.	Immediately after the intervention (about 3 months)
Mini Balance Evaluation Systems Test (Mini-BESTest)	This test is a clinical balance assessment tool designed to examine various elements of balance control. Scores range from 0 to 28, with higher scores indicating better balance.	Follow-Up (about 1 month post-intervention)
Prefrontal Cortex Activity	Prefrontal cortex activity (based on oxygenated hemoglobin) will be measured using Functional Near-Infrared Spectroscopy (fNIRS) during walking. This will be collected only for the cohort at Boston University.	Baseline 1
Prefrontal Cortex Activity	Prefrontal cortex activity (based on oxygenated hemoglobin) will be measured using Functional Near-Infrared Spectroscopy (fNIRS) during walking. This will be collected only for the cohort at Boston University.	Baseline 2 (2-3 weeks after Baseline 1)
Prefrontal Cortex Activity	Prefrontal cortex activity (based on oxygenated hemoglobin) will be measured using Functional Near-Infrared Spectroscopy (fNIRS) during walking. This will be collected only for the cohort at Boston University.	Immediately after the intervention (about 3 months)
Dual-Task Cost on Gait Speed	Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.	Baseline 1
Dual-Task Cost on Gait Speed	Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.	Baseline 2 (2-3 weeks after Baseline 1)
Dual-Task Cost on Gait Speed	Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.	Follow-Up (about 1 month post-intervention)
Dual-Task Cost on Gait Speed	Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.	Immediately after the intervention (about 3 months)
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part I is an examination of non-motor experiences of daily living. Part IA is conducted by the rater, and Part IB is completed independently of the rater. Scores range from 0 to 52, with higher scores indicating greater impairment.	Baseline 1
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part I is an examination of non-motor experiences of daily living. Part IA is conducted by the rater, and Part IB is completed independently of the rater. Scores range from 0 to 52, with higher scores indicating greater impairment.	Baseline 2 (2-3 weeks after Baseline 1)
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part I is an examination of non-motor experiences of daily living. Part IA is conducted by the rater, and Part IB is completed independently of the rater. Scores range from 0 to 52, with higher scores indicating greater impairment.	Immediately after the intervention (about 3 months)
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part I is an examination of non-motor experiences of daily living. Part IA is conducted by the rater, and Part IB is completed independently of the rater. Scores range from 0 to 52, with higher scores indicating greater impairment.	Follow-Up (about 1 month post-intervention)
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part II is a self-administered questionnaire to examine motor experiences of daily living. Scores range from 0 to 52, with higher scores indicating greater impairment.	Baseline 1
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part II is a self-administered questionnaire to examine motor experiences of daily living. Scores range from 0 to 52, with higher scores indicating greater impairment.	Baseline 2 (2-3 weeks after Baseline 1)
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part II is a self-administered questionnaire to examine motor experiences of daily living. Scores range from 0 to 52, with higher scores indicating greater impairment.	Follow-Up (about 1 month post-intervention)
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part II is a self-administered questionnaire to examine motor experiences of daily living. Scores range from 0 to 52, with higher scores indicating greater impairment.	Immediately after the intervention (about 3 months)
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination conducted by the rater. Scores range from 0 to 132, with higher scores indicating greater impairment.	Baseline 1
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination conducted by the rater. Scores range from 0 to 132, with higher scores indicating greater impairment.	Baseline 2 (2-3 weeks after Baseline 1)
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination conducted by the rater. Scores range from 0 to 132, with higher scores indicating greater impairment.	Immediately after the intervention (about 3 months)
Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)	The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination conducted by the rater. Scores range from 0 to 132, with higher scores indicating greater impairment.	Follow-Up (about 1 month post-intervention)
Variability of Stride Time During Walking with Digital Music Device	Stride time variability will be measured during walking with digital music device during in-lab assessments. 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 During Walking with Digital Music Device	Stride time variability will be measured during walking with digital music device during in-lab assessments. 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 During Walking with Digital Music Device	Stride time variability will be measured during walking with digital music device during in-lab assessments. 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 During Walking with Digital Music Device	Stride time variability will be measured during walking with digital music device during in-lab assessments. 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)
Speed During Walking with Digital Music Device	Speed (m/s) will be measured during walking with digital music device during in-lab assessments.	Baseline 1
Speed During Walking with Digital Music Device	Speed (m/s) will be measured during walking with digital music device during in-lab assessments.	Baseline 2 (2-3 weeks after Baseline 1)
Speed During Walking with Digital Music Device	Speed (m/s) will be measured during walking with digital music device during in-lab assessments.	Immediately after the intervention (about 3 months)
Speed During Walking with Digital Music Device	Speed (m/s) will be measured during walking with digital music device during in-lab assessments.	Follow-Up (about 1 month post-intervention)
Stride Length During Walking with Digital Music Device	Stride length (m) will be measured during walking with digital music device during in-lab assessments.	Baseline 1
Stride Length During Walking with Digital Music Device	Stride length (m) will be measured during walking with digital music device during in-lab assessments.	Baseline 2 (2-3 weeks after Baseline 1)
Stride Length During Walking with Digital Music Device	Stride length (m) will be measured during walking with digital music device during in-lab assessments.	Immediately after the intervention (about 3 months)
Stride Length During Walking with Digital Music Device	Stride length (m) will be measured during walking with digital music device during in-lab assessments.	Follow-Up (about 1 month post-intervention)
Parkinson's Disease Questionnaire-39 (PDQ-39)	The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).	Baseline 1
Parkinson's Disease Questionnaire-39 (PDQ-39)	The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).	Baseline 2 (2-3 weeks after Baseline 1)
Parkinson's Disease Questionnaire-39 (PDQ-39)	The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).	Immediately after the intervention (about 3 months)
Parkinson's Disease Questionnaire-39 (PDQ-39)	The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).	Follow-Up (about 1 month post-intervention)
Self-Efficacy of Walking - Duration (SEW-D)	The SEW-D is a 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), with higher scores indicating higher confidence.	Baseline 1
Self-Efficacy of Walking - Duration (SEW-D)	The SEW-D is a 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), with higher scores indicating higher confidence.	Baseline 2 (2-3 weeks after Baseline 1)
Self-Efficacy of Walking - Duration (SEW-D)	The SEW-D is a 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), with higher scores indicating higher confidence.	Immediately after the intervention (about 3 months)
Self-Efficacy of Walking - Duration (SEW-D)	The SEW-D is a 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), with higher scores indicating higher confidence.	Follow-Up (about 1 month post-intervention)
Activities-specific Balance Confidence (ABC)	This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities. The scores range from 0 to 100, with higher scores indicating greater confidence.	Baseline 1
Activities-specific Balance Confidence (ABC)	This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities. The scores range from 0 to 100, with higher scores indicating greater confidence.	Baseline 2 (2-3 weeks after Baseline 1)
Activities-specific Balance Confidence (ABC)	This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities. The scores range from 0 to 100, with higher scores indicating greater confidence.	Immediately after the intervention (about 3 months)
Activities-specific Balance Confidence (ABC)	This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities. The scores range from 0 to 100, with higher scores indicating greater confidence.	Follow-Up (about 1 month post-intervention)
Trail-Making Test (TMT)	This test measures the time it takes (seconds) to complete two visual-motor tasks. Higher scores indicate slower processing speed and greater cognitive impairment.	Baseline 1
Trail-Making Test (TMT)	This test measures the time it takes (seconds) to complete two visual-motor tasks. Higher scores indicate slower processing speed and greater cognitive impairment.	Baseline 2 (2-3 weeks after Baseline 1)
Trail-Making Test (TMT)	This test measures the time it takes (seconds) to complete two visual-motor tasks. Higher scores indicate slower processing speed and greater cognitive impairment.	Immediately after the intervention (about 3 months)
Trail-Making Test (TMT)	This test measures the time it takes (seconds) to complete two visual-motor tasks. Higher scores indicate slower processing speed and greater cognitive impairment.	Follow-Up (about 1 month post-intervention)
Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment. The score ranges from 0-30, with higher scores indicating less cognitive impairment.	Baseline 1
Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment. The score ranges from 0-30, with higher scores indicating less cognitive impairment.	Baseline 2 (2-3 weeks after Baseline 1)
Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment. The score ranges from 0-30, with higher scores indicating less cognitive impairment.	Immediately after the intervention (about 3 months)
Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment. The score ranges from 0-30, with higher scores indicating less cognitive impairment.	Follow-Up (about 1 month post-intervention)
Variability of Stride Time During MMQ Walking Program with Digital Music Device	Stride time variability will be measured during the MMQ walking program with the digital music device. Stride-to-stride variability of stride time of the gait cycle will be measured using integrated sensors from the music device. 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.	During training (about 3 months)
Speed During MMQ Walking Program with Digital Music Device	Speed (m/s) will be measured during the MMQ walking program with the digital music device. Speed will be measured using integrated sensors from the music device.	During training (about 3 months)
Stride Length During MMQ Walking Program with Digital Music Device	Stride length (m) will be measured during the MMQ walking program with the digital music device. Stride length will be measured using integrated sensors from the music device.	During training (about 3 months)

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: Washington University School of Medicine; University of Utah; Michael J. Fox Foundation for Parkinson's Research
• Investigators: Principal Investigator: Terry D. Ellis, PhD, PT, Boston University Center for Neurorehabilitation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Walking capacity; Parkinson's Disease (PD); Gait quality; Music-based intervention; Gait automaticity
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 8547; 55213069 (Other Grant/Funding Number: Michael J. Fox Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data may be shared within reasonable request.
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years after the publication of results
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes