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

2026年8月21日 更新者：Boston University Charles River Campus
The purpose of this research study is to examine the effects of a 3-month personalized community-based walking program using a digital music-based device designed for self-directed gait training in people with Parkinson disease (PD). The study uses music cues delivered through this digital device to improve walking outcomes. 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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The overall goal of this single-arm, multi-center repeated baselines study (N=162) is to examine how a personalized closed-loop music-based digital gait intervention, using MR-005 (MedRhythms, Inc.), improves gait quality, capacity, real-world walking performance, and gait automaticity in Parkinson disease (PD). Participants will complete a community-based, self-directed walking program using the digital music-based device 4 days a week for 12 weeks, designed to promote sustained walking beyond the use of the device.

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.

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Erica Clarke, BS
  • 电话号码：617-358-6157
  • 邮箱：egclarke@bu.edu

研究联系人备份

  • 姓名：Franchino Porciuncula, EdD PT DScPT
  • 电话号码：617-353-7571
  • 邮箱：fporciun@bu.edu

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Boston University Center for Neurorehabilitation
        • 接触：
        • 首席研究员：
          • Terry D. Ellis, PhD, PT
    • Missouri
      • St Louis、Missouri、美国、63110
        • 招聘中
        • Washington University School of Medicine
        • 接触：
        • 接触：
        • 首席研究员：
          • Gammon Earhart, PT, PhD
    • Utah
      • Salt Lake City、Utah、美国、84108
        • 招聘中
        • University of Utah
        • 接触：
        • 首席研究员：
          • Lee Dibble, PT, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：MyMusiQ (MMQ) Walking intervention
Participants use MR-005 (MedRhythms, Inc., Portland, ME) during self-directed, home/community-based walking for 12 weeks to improve walking outcomes.
设备：MR-005 (MedRhythms, Inc., Portland, ME)
MR-005 (MedRhythms, Inc., Portland, ME) is a personalized, closed-loop, autonomous music-based digital gait intervention designed for self-directed gait training in Parkinson disease (PD). The system uses two shoe-worn gait sensors that communicate in real time with proprietary software on a touchscreen device, which controls the delivery of individualized, progressive rhythmic auditory stimulation (RAS), provided as music cues through bone conduction headphones. The software operates autonomously and does not require manual input or adjustment by the patient or clinician during a session.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Minutes of Moderate Intensity Walking
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Immediately after the intervention (about 3 months)
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
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Immediately after the intervention (about 3 months)
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
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Immediately after the intervention (about 3 months)
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
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：Baseline 1
Gait speed (m/s) will be measured using research-grade wearable sensors.
Baseline 1
Gait Speed
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
Gait speed (m/s) will be measured using research-grade wearable sensors.
Baseline 2 (2-3 weeks after Baseline 1)
Gait Speed
大体时间：Immediately after the intervention (about 3 months)
Gait speed (m/s) will be measured using research-grade wearable sensors.
Immediately after the intervention (about 3 months)
Gait Speed
大体时间：Follow-Up (about 1 month post-intervention)
Gait speed (m/s) will be measured using research-grade wearable sensors.
Follow-Up (about 1 month post-intervention)
Stride Length
大体时间：Baseline 1
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Baseline 1
Stride Length
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Baseline 2 (2-3 weeks after Baseline 1)
Stride Length
大体时间：Immediately after the intervention (about 3 months)
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Immediately after the intervention (about 3 months)
Stride Length
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Immediately after the intervention (about 3 months)
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
大体时间：Follow-Up (about 1 month post-intervention)
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)

次要结果测量

结果测量
措施说明
大体时间
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Immediately after the intervention (about 3 months)
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
大体时间：Follow-Up (about 1 month post-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.
Follow-Up (about 1 month post-intervention)
10-Meter Walk Test (10MWT) - Fast Walking Speed
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Immediately after the intervention (about 3 months)
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
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Immediately after the intervention (about 3 months)
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
大体时间：Follow-Up (about 1 month post-intervention)
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)
大体时间：Baseline 1
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)
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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)
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Baseline 1
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)
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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)
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Immediately after the intervention (about 3 months)
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
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Baseline 1
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)
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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)
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Follow-Up (about 1 month post-intervention)
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)
大体时间：Baseline 1
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)
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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)
大体时间：Follow-Up (about 1 month post-intervention)
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)
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Baseline 1
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)
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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)
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Immediately after the intervention (about 3 months)
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
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Immediately after the intervention (about 3 months)
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
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：Baseline 1
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
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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
大体时间：Immediately after the intervention (about 3 months)
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
大体时间：Follow-Up (about 1 month post-intervention)
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)
大体时间：Baseline 1
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)
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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)
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Follow-Up (about 1 month post-intervention)
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)
大体时间：Baseline 1
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)
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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)
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Follow-Up (about 1 month post-intervention)
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)
大体时间：Baseline 1
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)
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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)
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Follow-Up (about 1 month post-intervention)
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)
大体时间：Baseline 1
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)
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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)
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Follow-Up (about 1 month post-intervention)
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)
大体时间：Baseline 1
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)
大体时间：Baseline 2 (2-3 weeks after Baseline 1)
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)
大体时间：Immediately after the intervention (about 3 months)
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)
大体时间：Follow-Up (about 1 month post-intervention)
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
大体时间：During training (about 3 months)
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
大体时间：During training (about 3 months)
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
大体时间：During training (about 3 months)
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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Boston University Charles River Campus

合作者

Washington University School of Medicine
University of Utah
Michael J. Fox Foundation for Parkinson's Research

调查人员

  • 首席研究员：Terry D. Ellis, PhD PT、Boston University Center for Neurorehabilitation

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月20日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2029年2月28日

研究注册日期

首次提交

2026年7月6日

首先提交符合 QC 标准的

2026年7月13日

首次发布 (实际的)

2026年7月15日

研究记录更新

最后更新发布 (实际的)

2026年8月24日

上次提交的符合 QC 标准的更新

2026年8月21日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 8547
  • 55213069 (其他赠款/资助编号：Michael J. Fox Foundation)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified data may be shared within reasonable request.

IPD 共享时间框架

Beginning 3 months and ending 3 years after the publication of results

IPD 共享访问标准

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 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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