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

21 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

200

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Erica Clarke, BS
  • Numéro de téléphone: 617-358-6157
  • E-mail: egclarke@bu.edu

Sauvegarde des contacts de l'étude

  • Nom: Franchino Porciuncula, EdD PT DScPT
  • Numéro de téléphone: 617-353-7571
  • E-mail: fporciun@bu.edu

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02215
        • Recrutement
        • Boston University Center for Neurorehabilitation
        • Contact:
          • Erica Clarke, BS
          • Numéro de téléphone: 617-358-6157
          • E-mail: egclarke@bu.edu
        • Chercheur principal:
          • Terry D. Ellis, PhD, PT
    • Missouri
      • St Louis, Missouri, États-Unis, 63110
        • Recrutement
        • Washington University School of Medicine
        • Contact:
        • Contact:
          • Kerri Rawson, PhD, MS
          • Numéro de téléphone: 813-468-8900
          • E-mail: rawson@wustl.edu
        • Chercheur principal:
          • Gammon Earhart, PT, PhD
    • Utah
      • Salt Lake City, Utah, États-Unis, 84108
        • Recrutement
        • University of Utah
        • Contact:
        • Chercheur principal:
          • Lee Dibble, PT, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Minutes of Moderate Intensity Walking
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline 1
Gait speed (m/s) will be measured using research-grade wearable sensors.
Baseline 1
Gait Speed
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline 1
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Baseline 1
Stride Length
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Boston University Charles River Campus

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Terry D. Ellis, PhD PT, Boston University Center for Neurorehabilitation

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 août 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

28 février 2029

Dates d'inscription aux études

Première soumission

6 juillet 2026

Première soumission répondant aux critères de contrôle qualité

13 juillet 2026

Première publication (Réel)

15 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 8547
  • 55213069 (Autre subvention/numéro de financement: Michael J. Fox Foundation)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified data may be shared within reasonable request.

Délai de partage IPD

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

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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