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Parkinson's Disease (PD)MyMusiQNCT07705373

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

A study testing MR-005 (MedRhythms, Inc., Portland, ME) in people with Parkinson's Disease (PD), run by Boston University Charles River Campus at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Parkinson's Disease (PD)
What is being tested?
MR-005 (MedRhythms, Inc., Portland, ME)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesUnited States
Study dates
20 Aug 2026to 28 Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 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
Show all 15Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Erica Clarke, BS contact

617-358-6157

egclarke@bu.edu

Franchino Porciuncula, EdD PT DScPT contact

617-353-7571

fporciun@bu.edu

United States3 sites, 3 recruiting

  • Boston University Center for Neurorehabilitation

    Boston, Massachusetts, 02215

    Erica Clarke, BS, 617-358-6157, egclarke@bu.edu

    Terry D. Ellis, PhD, PT

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84108

    Rheanna Anderson, MS, 801-587-3615, rheanna.anderson@utah.edu

    Lee Dibble, PT, PhD

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Kayla Bell, PT, DPT, 314-273-6016, kayla.bell@wustl.edu

    Kerri Rawson, PhD, MS, 813-468-8900, rawson@wustl.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
MR-005 (MedRhythms, Inc., Portland, ME)
Keywords
Music-based intervention, Gait quality, Walking capacity, Gait automaticity, Parkinson's Disease (PD)
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MR-005 (MedRhythms, Inc., Portland, ME)Device

    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.

Study groups in NCT07705373
Study groupRoleWhat they receive
MyMusiQ (MMQ) Walking interventionExperimentalParticipants use MR-005 (MedRhythms, Inc., Portland, ME) during self-directed, home/community-based walking for 12 weeks to improve walking outcomes.
Receives: Device: MR-005 (MedRhythms, Inc., Portland, ME)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minutes of Moderate Intensity Walking

    The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min, measured using research-grade wearable sensors.

    Measured: Baseline 1

  2. Minutes of Moderate Intensity Walking

    The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min, measured using research-grade wearable sensors.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  3. Minutes of Moderate Intensity Walking

    The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min, measured using research-grade wearable sensors.

    Measured: Immediately after the intervention (about 3 months)

  4. Minutes of Moderate Intensity Walking

    The amount of moderate intensity walking, defined as mean number of minutes per day with >100 steps/min, measured using research-grade wearable sensors.

    Measured: Follow-Up (about 1 month post-intervention)

  5. Daily Step Counts

    Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.

    Measured: Baseline 1

  6. Daily Step Counts

    Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  7. Daily Step Counts

    Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.

    Measured: Immediately after the intervention (about 3 months)

  8. Daily Step Counts

    Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.

    Measured: Follow-Up (about 1 month post-intervention)

  9. 6-Minute Walk Test

    This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.

    Measured: Baseline 1

  10. 6-Minute Walk Test

    This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  11. 6-Minute Walk Test

    This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.

    Measured: Immediately after the intervention (about 3 months)

  12. 6-Minute Walk Test

    This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.

    Measured: Follow-Up (about 1 month post-intervention)

  13. Gait Speed

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

    Measured: Baseline 1

  14. Gait Speed

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

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  15. Gait Speed

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

    Measured: Immediately after the intervention (about 3 months)

  16. Gait Speed

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

    Measured: Follow-Up (about 1 month post-intervention)

  17. Stride Length

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

    Measured: Baseline 1

  18. Stride Length

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

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  19. Stride Length

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

    Measured: Immediately after the intervention (about 3 months)

  20. Stride Length

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

    Measured: Follow-Up (about 1 month post-intervention)

  21. Variability of Stride Time

    Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.

    Measured: Baseline 1

  22. Variability of Stride Time

    Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  23. Variability of Stride Time

    Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.

    Measured: Immediately after the intervention (about 3 months)

  24. Variability of Stride Time

    Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.

    Measured: Follow-Up (about 1 month post-intervention)

Secondary outcomes (75)

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

    This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway.

    Measured: Baseline 1

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

    This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

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

    This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway.

    Measured: Immediately after the intervention (about 3 months)

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

    This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) on a ten-meter straight walkway.

    Measured: Follow-Up (about 1 month post-intervention)

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

    This is a test of short-distance walking function. The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.

    Measured: Baseline 1

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

    This is a test of short-distance walking function. The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

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

    This is a test of short-distance walking function. The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.

    Measured: Immediately after the intervention (about 3 months)

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

    This is a test of short-distance walking function. The participant will be asked to walk at fast walking speed (FWS) on a ten-meter straight walkway.

    Measured: Follow-Up (about 1 month post-intervention)

  9. Five Times Sit-to-Stand

    This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.

    Measured: Baseline 1

  10. Five Times Sit-to-Stand

    This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  11. Five Times Sit-to-Stand

    This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.

    Measured: Immediately after the intervention (about 3 months)

  12. Five Times Sit-to-Stand

    This test provides a method to quantify the time it takes for a person to stand up and sit down five times without using their hands.

    Measured: Follow-Up (about 1 month post-intervention)

  13. Generic Walking Scale (Walk-12G)

    This test is a self-report questionnaire that measures everyday walking difficulties. Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.

    Measured: Baseline 1

  14. Generic Walking Scale (Walk-12G)

    This test is a self-report questionnaire that measures everyday walking difficulties. Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  15. Generic Walking Scale (Walk-12G)

    This test is a self-report questionnaire that measures everyday walking difficulties. Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.

    Measured: Immediately after the intervention (about 3 months)

  16. Generic Walking Scale (Walk-12G)

    This test is a self-report questionnaire that measures everyday walking difficulties. Scores range from 12 to 60, with higher scores indicating greater perceived walking difficulties.

    Measured: Follow-Up (about 1 month post-intervention)

  17. Global Rating of Change (GROC) Scale

    This self-reported rating scale measures overall perceived improvement in areas related to amount of walking, intensity of walking, and walking capacity. Scores range from -7 to +7, with higher scores indicating greater improvement.

    Measured: Immediately after the intervention (about 3 months)

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

    This test is a clinical balance assessment tool designed to examine various elements of balance control. Scores range from 0 to 28, with higher scores indicating better balance.

    Measured: Baseline 1

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

    This test is a clinical balance assessment tool designed to examine various elements of balance control. Scores range from 0 to 28, with higher scores indicating better balance.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

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

    This test is a clinical balance assessment tool designed to examine various elements of balance control. Scores range from 0 to 28, with higher scores indicating better balance.

    Measured: Immediately after the intervention (about 3 months)

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

    This test is a clinical balance assessment tool designed to examine various elements of balance control. Scores range from 0 to 28, with higher scores indicating better balance.

    Measured: Follow-Up (about 1 month post-intervention)

  22. Prefrontal Cortex Activity

    Prefrontal cortex activity (based on oxygenated hemoglobin) will be measured using Functional Near-Infrared Spectroscopy (fNIRS) during walking. This will be collected only for the cohort at Boston University.

    Measured: Baseline 1

  23. Prefrontal Cortex Activity

    Prefrontal cortex activity (based on oxygenated hemoglobin) will be measured using Functional Near-Infrared Spectroscopy (fNIRS) during walking. This will be collected only for the cohort at Boston University.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  24. Prefrontal Cortex Activity

    Prefrontal cortex activity (based on oxygenated hemoglobin) will be measured using Functional Near-Infrared Spectroscopy (fNIRS) during walking. This will be collected only for the cohort at Boston University.

    Measured: Immediately after the intervention (about 3 months)

  25. Dual-Task Cost on Gait Speed

    Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.

    Measured: Baseline 1

  26. Dual-Task Cost on Gait Speed

    Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  27. Dual-Task Cost on Gait Speed

    Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.

    Measured: Follow-Up (about 1 month post-intervention)

  28. Dual-Task Cost on Gait Speed

    Dual-task cost is the difference between single-task walking and dual-task walking divided by single-task walking, multiplied by 100 to express as a percentage.

    Measured: Immediately after the intervention (about 3 months)

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part I is an examination of non-motor experiences of daily living. Part IA is conducted by the rater, and Part IB is completed independently of the rater. Scores range from 0 to 52, with higher scores indicating greater impairment.

    Measured: Baseline 1

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part I is an examination of non-motor experiences of daily living. Part IA is conducted by the rater, and Part IB is completed independently of the rater. Scores range from 0 to 52, with higher scores indicating greater impairment.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part I is an examination of non-motor experiences of daily living. Part IA is conducted by the rater, and Part IB is completed independently of the rater. Scores range from 0 to 52, with higher scores indicating greater impairment.

    Measured: Immediately after the intervention (about 3 months)

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part I is an examination of non-motor experiences of daily living. Part IA is conducted by the rater, and Part IB is completed independently of the rater. Scores range from 0 to 52, with higher scores indicating greater impairment.

    Measured: Follow-Up (about 1 month post-intervention)

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part II is a self-administered questionnaire to examine motor experiences of daily living. Scores range from 0 to 52, with higher scores indicating greater impairment.

    Measured: Baseline 1

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part II is a self-administered questionnaire to examine motor experiences of daily living. Scores range from 0 to 52, with higher scores indicating greater impairment.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part II is a self-administered questionnaire to examine motor experiences of daily living. Scores range from 0 to 52, with higher scores indicating greater impairment.

    Measured: Follow-Up (about 1 month post-intervention)

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part II is a self-administered questionnaire to examine motor experiences of daily living. Scores range from 0 to 52, with higher scores indicating greater impairment.

    Measured: Immediately after the intervention (about 3 months)

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination conducted by the rater. Scores range from 0 to 132, with higher scores indicating greater impairment.

    Measured: Baseline 1

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination conducted by the rater. Scores range from 0 to 132, with higher scores indicating greater impairment.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination conducted by the rater. Scores range from 0 to 132, with higher scores indicating greater impairment.

    Measured: Immediately after the intervention (about 3 months)

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

    The MDS-UPDRS is the most widely used clinical rating scale for Parkinson disease. Part III is a motor examination conducted by the rater. Scores range from 0 to 132, with higher scores indicating greater impairment.

    Measured: Follow-Up (about 1 month post-intervention)

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

    Stride time variability will be measured during walking with digital music device during in-lab assessments. Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.

    Measured: Baseline 1

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

    Stride time variability will be measured during walking with digital music device during in-lab assessments. Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

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

    Stride time variability will be measured during walking with digital music device during in-lab assessments. Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.

    Measured: Immediately after the intervention (about 3 months)

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

    Stride time variability will be measured during walking with digital music device during in-lab assessments. Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.

    Measured: Follow-Up (about 1 month post-intervention)

  45. Speed During Walking with Digital Music Device

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

    Measured: Baseline 1

  46. Speed During Walking with Digital Music Device

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

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  47. Speed During Walking with Digital Music Device

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

    Measured: Immediately after the intervention (about 3 months)

  48. Speed During Walking with Digital Music Device

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

    Measured: Follow-Up (about 1 month post-intervention)

  49. Stride Length During Walking with Digital Music Device

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

    Measured: Baseline 1

  50. Stride Length During Walking with Digital Music Device

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

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  51. Stride Length During Walking with Digital Music Device

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

    Measured: Immediately after the intervention (about 3 months)

  52. Stride Length During Walking with Digital Music Device

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

    Measured: Follow-Up (about 1 month post-intervention)

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

    The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).

    Measured: Baseline 1

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

    The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

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

    The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).

    Measured: Immediately after the intervention (about 3 months)

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

    The PDQ-39 is a self-report questionnaire that assesses quality of life across 8 different dimensions. Items are scored based on a 5-point ordinal system with lower scores reflecting better quality of life (min = 0, max = 100).

    Measured: Follow-Up (about 1 month post-intervention)

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

    The SEW-D is a self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident), with higher scores indicating higher confidence.

    Measured: Baseline 1

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

    The SEW-D is a self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident), with higher scores indicating higher confidence.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

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

    The SEW-D is a self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident), with higher scores indicating higher confidence.

    Measured: Immediately after the intervention (about 3 months)

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

    The SEW-D is a self-report that will be administered to determine participants' beliefs of their physical capabilities to successfully complete incremental 5-minute intervals (5 to 40 minutes) of walking at a moderately fast pace, with responses made on 11-point Likert scale (0% = not at all confident; 100% = highly confident), with higher scores indicating higher confidence.

    Measured: Follow-Up (about 1 month post-intervention)

  61. Activities-specific Balance Confidence (ABC)

    This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities. The scores range from 0 to 100, with higher scores indicating greater confidence.

    Measured: Baseline 1

  62. Activities-specific Balance Confidence (ABC)

    This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities. The scores range from 0 to 100, with higher scores indicating greater confidence.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  63. Activities-specific Balance Confidence (ABC)

    This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities. The scores range from 0 to 100, with higher scores indicating greater confidence.

    Measured: Immediately after the intervention (about 3 months)

  64. Activities-specific Balance Confidence (ABC)

    This test is a questionnaire that measures an individual's confidence (in percentage) that he/she will not lose balance or become unsteady while performing physical activities. The scores range from 0 to 100, with higher scores indicating greater confidence.

    Measured: Follow-Up (about 1 month post-intervention)

  65. Trail-Making Test (TMT)

    This test measures the time it takes (seconds) to complete two visual-motor tasks. Higher scores indicate slower processing speed and greater cognitive impairment.

    Measured: Baseline 1

  66. Trail-Making Test (TMT)

    This test measures the time it takes (seconds) to complete two visual-motor tasks. Higher scores indicate slower processing speed and greater cognitive impairment.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  67. Trail-Making Test (TMT)

    This test measures the time it takes (seconds) to complete two visual-motor tasks. Higher scores indicate slower processing speed and greater cognitive impairment.

    Measured: Immediately after the intervention (about 3 months)

  68. Trail-Making Test (TMT)

    This test measures the time it takes (seconds) to complete two visual-motor tasks. Higher scores indicate slower processing speed and greater cognitive impairment.

    Measured: Follow-Up (about 1 month post-intervention)

  69. Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment. The score ranges from 0-30, with higher scores indicating less cognitive impairment.

    Measured: Baseline 1

  70. Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment. The score ranges from 0-30, with higher scores indicating less cognitive impairment.

    Measured: Baseline 2 (2-3 weeks after Baseline 1)

  71. Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment. The score ranges from 0-30, with higher scores indicating less cognitive impairment.

    Measured: Immediately after the intervention (about 3 months)

  72. Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a brief screening tool designed to examine cognitive impairment. The score ranges from 0-30, with higher scores indicating less cognitive impairment.

    Measured: Follow-Up (about 1 month post-intervention)

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

    Stride time variability will be measured during the MMQ walking program with the digital music device. Stride-to-stride variability of stride time of the gait cycle will be measured using integrated sensors from the music device. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.

    Measured: During training (about 3 months)

  74. Speed During MMQ Walking Program with Digital Music Device

    Speed (m/s) will be measured during the MMQ walking program with the digital music device. Speed will be measured using integrated sensors from the music device.

    Measured: During training (about 3 months)

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

    Stride length (m) will be measured during the MMQ walking program with the digital music device. Stride length will be measured using integrated sensors from the music device.

    Measured: During training (about 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start20 Aug 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07705373
Sponsor's protocol ID
8547
Other IDs
55213069
Acronym
MyMusiQ
Status last verified
Aug 2026
First submitted
6 Jul 2026
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified data may be shared within reasonable request.

Publications

  • Zajac JA, Porciuncula F, Cavanaugh JT, McGregor C, Harris BA, Smayda KE, Awad LN, Pantelyat A, Ellis TD. Feasibility and Proof-of-Concept of Delivering an Autonomous Music-Based Digital Walking Intervention to Persons with Parkinson's Disease in a Naturalistic Setting. J Parkinsons Dis. 2023;13(7):1253-1265. doi: 10.3233/JPD-230169.

    PubMed 37840504

  • Cavanaugh JT, Porciuncula F, Zajac JA, Baker T, Wendel N, Awad LN, Ellis TD. Gait Responses in People with Parkinson Disease During Autonomous Closed-loop Rhythmic Auditory Stimulation: An Exploratory Analysis. Neurorehabil Neural Repair. 2025 Aug;39(8):666-676. doi: 10.1177/15459683251340910. Epub 2025 May 29.

    PubMed 40438970

  • Porciuncula F, Cavanaugh JT, Zajac J, Wendel N, Baker T, Arumukhom Revi D, Eklund N, Holmes MB, Awad LN, Ellis TD. Amplifying walking activity in Parkinson's disease through autonomous music-based rhythmic auditory stimulation: randomized controlled trial. NPJ Parkinsons Dis. 2025 Apr 29;11(1):100. doi: 10.1038/s41531-025-00952-x.

    PubMed 40301366

Questions about this trial

What is this clinical trial studying?

A study testing MR-005 (MedRhythms, Inc., Portland, ME) in people with Parkinson's Disease (PD), run by Boston University Charles River Campus at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Erica Clarke, BS (617-358-6157, egclarke@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minutes of Moderate Intensity Walking (time frame: Baseline 1). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07705373, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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