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NCT Number: NCT07705373

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

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

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Key information

Conditions

Parkinson's Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Center for Neurorehabilitation, Boston, Massachusetts, United States

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About this study

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

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

The digital music device is comprised of foot sensors, a smart phone with pre-installed proprietary software application, and headphones. The device obtains real-time walking data through movement sensors that communicate wirelessly with the smartphone application software. Music cues are tailored to the person's walking pattern, and are transmitted wirelessly to the headphones. Music cues are time-shifted to the user's baseline cadence and adjusted in real-time based on the user's walking performance metrics.

Primary outcomes

  1. Minutes of Moderate Intensity Walking

    Time frame: 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.

  2. Minutes of Moderate Intensity Walking

    Time frame: 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.

  3. Minutes of Moderate Intensity Walking

    Time frame: 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.

  4. Minutes of Moderate Intensity Walking

    Time frame: 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.

  5. Daily Step Counts

    Time frame: 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.

  6. Daily Step Counts

    Time frame: 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.

  7. Daily Step Counts

    Time frame: 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.

  8. Daily Step Counts

    Time frame: 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.

  9. 6-Minute Walk Test

    Time frame: 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.

  10. 6-Minute Walk Test

    Time frame: 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.

  11. 6-Minute Walk Test

    Time frame: 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.

  12. 6-Minute Walk Test

    Time frame: 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.

  13. Gait Speed

    Time frame: Baseline 1

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

  14. Gait Speed

    Time frame: Baseline 2 (2-3 weeks after Baseline 1)

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

  15. Gait Speed

    Time frame: Immediately after the intervention (about 3 months)

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

  16. Gait Speed

    Time frame: Follow-Up (about 1 month post-intervention)

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

  17. Stride Length

    Time frame: Baseline 1

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

  18. Stride Length

    Time frame: Baseline 2 (2-3 weeks after Baseline 1)

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

  19. Stride Length

    Time frame: Immediately after the intervention (about 3 months)

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

  20. Stride Length

    Time frame: Follow-Up (about 1 month post-intervention)

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

  21. Variability of Stride Time

    Time frame: 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.

  22. Variability of Stride Time

    Time frame: 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.

  23. Variability of Stride Time

    Time frame: 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.

  24. Variability of Stride Time

    Time frame: 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.

Secondary outcomes

  1. 10-Meter Walk Test (10MWT) - Comfortable Walking Speed

    Time frame: 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.

  2. 10-Meter Walk Test (10MWT) - Comfortable Walking Speed

    Time frame: 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.

  3. 10-Meter Walk Test (10MWT) - Comfortable Walking Speed

    Time frame: 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.

  4. 10-Meter Walk Test (10MWT) - Comfortable Walking Speed

    Time frame: 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.

  5. 10-Meter Walk Test (10MWT) - Fast Walking Speed

    Time frame: 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.

  6. 10-Meter Walk Test (10MWT) - Fast Walking Speed

    Time frame: 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.

  7. 10-Meter Walk Test (10MWT) - Fast Walking Speed

    Time frame: 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.

  8. 10-Meter Walk Test (10MWT) - Fast Walking Speed

    Time frame: 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.

  9. Five Times Sit-to-Stand

    Time frame: 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.

  10. Five Times Sit-to-Stand

    Time frame: 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.

  11. Five Times Sit-to-Stand

    Time frame: 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.

  12. Five Times Sit-to-Stand

    Time frame: 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.

  13. Generic Walking Scale (Walk-12G)

    Time frame: 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.

  14. Generic Walking Scale (Walk-12G)

    Time frame: 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.

  15. Generic Walking Scale (Walk-12G)

    Time frame: 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.

  16. Generic Walking Scale (Walk-12G)

    Time frame: 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.

  17. Global Rating of Change (GROC) Scale

    Time frame: 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.

  18. Mini Balance Evaluation Systems Test (Mini-BESTest)

    Time frame: 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.

  19. Mini Balance Evaluation Systems Test (Mini-BESTest)

    Time frame: 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.

  20. Mini Balance Evaluation Systems Test (Mini-BESTest)

    Time frame: 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.

  21. Mini Balance Evaluation Systems Test (Mini-BESTest)

    Time frame: 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.

  22. Prefrontal Cortex Activity

    Time frame: 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.

  23. Prefrontal Cortex Activity

    Time frame: 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.

  24. Prefrontal Cortex Activity

    Time frame: 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.

  25. Dual-Task Cost on Gait Speed

    Time frame: 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.

  26. Dual-Task Cost on Gait Speed

    Time frame: 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.

  27. Dual-Task Cost on Gait Speed

    Time frame: 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.

  28. Dual-Task Cost on Gait Speed

    Time frame: 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.

  29. Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)

    Time frame: 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.

  30. Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)

    Time frame: 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.

  31. Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)

    Time frame: 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.

  32. Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section I)

    Time frame: 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.

  33. Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)

    Time frame: 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.

  34. Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)

    Time frame: 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.

  35. Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)

    Time frame: 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.

  36. Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS Section II)

    Time frame: 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.

  37. Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)

    Time frame: 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.

  38. Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)

    Time frame: 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.

  39. Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)

    Time frame: 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.

  40. Movement Disorder Society Unified Parkinson Disease Rating Scale Motor Subsection (MDS-UPDRS Section III)

    Time frame: 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.

  41. Variability of Stride Time During Walking with Digital Music Device

    Time frame: 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.

  42. Variability of Stride Time During Walking with Digital Music Device

    Time frame: 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.

  43. Variability of Stride Time During Walking with Digital Music Device

    Time frame: 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.

  44. Variability of Stride Time During Walking with Digital Music Device

    Time frame: 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.

  45. Speed During Walking with Digital Music Device

    Time frame: Baseline 1

    Speed (m/s) will be measured during walking with digital music device during in-lab assessments.

  46. Speed During Walking with Digital Music Device

    Time frame: Baseline 2 (2-3 weeks after Baseline 1)

    Speed (m/s) will be measured during walking with digital music device during in-lab assessments.

  47. Speed During Walking with Digital Music Device

    Time frame: Immediately after the intervention (about 3 months)

    Speed (m/s) will be measured during walking with digital music device during in-lab assessments.

  48. Speed During Walking with Digital Music Device

    Time frame: Follow-Up (about 1 month post-intervention)

    Speed (m/s) will be measured during walking with digital music device during in-lab assessments.

  49. Stride Length During Walking with Digital Music Device

    Time frame: Baseline 1

    Stride length (m) will be measured during walking with digital music device during in-lab assessments.

  50. Stride Length During Walking with Digital Music Device

    Time frame: Baseline 2 (2-3 weeks after Baseline 1)

    Stride length (m) will be measured during walking with digital music device during in-lab assessments.

  51. Stride Length During Walking with Digital Music Device

    Time frame: Immediately after the intervention (about 3 months)

    Stride length (m) will be measured during walking with digital music device during in-lab assessments.

  52. Stride Length During Walking with Digital Music Device

    Time frame: Follow-Up (about 1 month post-intervention)

    Stride length (m) will be measured during walking with digital music device during in-lab assessments.

  53. Parkinson's Disease Questionnaire-39 (PDQ-39)

    Time frame: 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).

  54. Parkinson's Disease Questionnaire-39 (PDQ-39)

    Time frame: 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).

  55. Parkinson's Disease Questionnaire-39 (PDQ-39)

    Time frame: 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).

  56. Parkinson's Disease Questionnaire-39 (PDQ-39)

    Time frame: 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).

  57. Self-Efficacy of Walking - Duration (SEW-D)

    Time frame: 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.

  58. Self-Efficacy of Walking - Duration (SEW-D)

    Time frame: 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.

  59. Self-Efficacy of Walking - Duration (SEW-D)

    Time frame: 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.

  60. Self-Efficacy of Walking - Duration (SEW-D)

    Time frame: 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.

  61. Activities-specific Balance Confidence (ABC)

    Time frame: 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.

  62. Activities-specific Balance Confidence (ABC)

    Time frame: 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.

  63. Activities-specific Balance Confidence (ABC)

    Time frame: 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.

  64. Activities-specific Balance Confidence (ABC)

    Time frame: 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.

  65. Trail-Making Test (TMT)

    Time frame: 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.

  66. Trail-Making Test (TMT)

    Time frame: 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.

  67. Trail-Making Test (TMT)

    Time frame: 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.

  68. Trail-Making Test (TMT)

    Time frame: 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.

  69. Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

  70. Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

  71. Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

  72. Montreal Cognitive Assessment (MoCA)

    Time frame: 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.

  73. Variability of Stride Time During MMQ Walking Program with Digital Music Device

    Time frame: 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.

  74. Speed During MMQ Walking Program with Digital Music Device

    Time frame: 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.

  75. Stride Length During MMQ Walking Program with Digital Music Device

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erica Clarke, BS

CONTACT

[email protected]

617-358-6157

Franchino Porciuncula, EdD, PT, DScPT

CONTACT

[email protected]

617-353-7571

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

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

Registry information

Acronym: MyMusiQ

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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