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

21 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Erica Clarke, BS
  • Telefoonnummer: 617-358-6157
  • E-mail: egclarke@bu.edu

Studie Contact Back-up

  • Naam: Franchino Porciuncula, EdD PT DScPT
  • Telefoonnummer: 617-353-7571
  • E-mail: fporciun@bu.edu

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Werving
        • Boston University Center for Neurorehabilitation
        • Contact:
        • Hoofdonderzoeker:
          • Terry D. Ellis, PhD, PT
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63110
        • Werving
        • Washington University School of Medicine
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Gammon Earhart, PT, PhD
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84108
        • Werving
        • University of Utah
        • Contact:
        • Hoofdonderzoeker:
          • Lee Dibble, PT, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Minutes of Moderate Intensity Walking
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline 1
Gait speed (m/s) will be measured using research-grade wearable sensors.
Baseline 1
Gait Speed
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline 1
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Baseline 1
Stride Length
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
10-Meter Walk Test (10MWT) - Comfortable Walking Speed
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Boston University Charles River Campus

Medewerkers

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

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 augustus 2026

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

28 februari 2029

Studieregistratiedata

Eerst ingediend

6 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 juli 2026

Eerst geplaatst (Werkelijk)

15 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

21 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 8547
  • 55213069 (Ander subsidie-/financieringsnummer: Michael J. Fox Foundation)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified data may be shared within reasonable request.

IPD-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren