Recruiting

MyMusiQ

Sponsor:

Boston University Charles River Campus

Code:

NCT07705373

Conditions

Parkinson's Disease (PD)

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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). 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.

Conditions

Parkinson's Disease (PD)

Study ID

NCT07705373

Start date

Aug 20, 2026

Status verified date

Aug, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Minutes of Moderate Intensity Walking [ Time Frame: Baseline 1 ]
  • Minutes of Moderate Intensity Walking [ Time Frame: Baseline 2 (2-3 weeks after Baseline 1) ]
  • Minutes of Moderate Intensity Walking [ Time Frame: Immediately after the intervention (about 3 months) ]
  • Minutes of Moderate Intensity Walking [ Time Frame: Follow-Up (about 1 month post-intervention) ]
  • Daily Step Counts [ Time Frame: Baseline 1 ]
  • Daily Step Counts [ Time Frame: Baseline 2 (2-3 weeks after Baseline 1) ]
  • Daily Step Counts [ Time Frame: Immediately after the intervention (about 3 months) ]
  • Daily Step Counts [ Time Frame: Follow-Up (about 1 month post-intervention) ]
  • 6-Minute Walk Test [ Time Frame: Baseline 1 ]
  • 6-Minute Walk Test [ Time Frame: Baseline 2 (2-3 weeks after Baseline 1) ]
  • 6-Minute Walk Test [ Time Frame: Immediately after the intervention (about 3 months) ]
  • 6-Minute Walk Test [ Time Frame: Follow-Up (about 1 month post-intervention) ]
  • Gait Speed [ Time Frame: Baseline 1 ]
  • Gait Speed [ Time Frame: Baseline 2 (2-3 weeks after Baseline 1) ]
  • Gait Speed [ Time Frame: Immediately after the intervention (about 3 months) ]
  • Gait Speed [ Time Frame: Follow-Up (about 1 month post-intervention) ]
  • Stride Length [ Time Frame: Baseline 1 ]
  • Stride Length [ Time Frame: Baseline 2 (2-3 weeks after Baseline 1) ]
  • Stride Length [ Time Frame: Immediately after the intervention (about 3 months) ]
  • Stride Length [ Time Frame: Follow-Up (about 1 month post-intervention) ]
  • Variability of Stride Time [ Time Frame: Baseline 1 ]
  • Variability of Stride Time [ Time Frame: Baseline 2 (2-3 weeks after Baseline 1) ]
  • Variability of Stride Time [ Time Frame: Immediately after the intervention (about 3 months) ]
  • Variability of Stride Time [ Time Frame: Follow-Up (about 1 month post-intervention) ]

Central Contacts and Locations

Central contacts

Erica Clarke, BS

617-358-6157egclarke@bu.edu

Franchino Porciuncula, EdD PT DScPT

617-353-7571fporciun@bu.edu

Locations

Boston University Center for Neurorehabilitation

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Erica Clarke, BS

617-358-6157egclarke@bu.edu

Principal Investigator:

Terry D. Ellis, PhD, PT

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Kayla Bell, PT, DPT

314-273-6016kayla.bell@wustl.edu

Kerri Rawson, PhD, MS

813-468-8900rawson@wustl.edu

Principal Investigator:

Gammon Earhart, PT, PhD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Rheanna Anderson, MS

801-587-3615rheanna.anderson@utah.edu

Principal Investigator:

Lee Dibble, PT, PhD

More Information

Sponsor

Boston University Charles River Campus

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Music-based intervention
  • Gait quality
  • Walking capacity
  • Gait automaticity
  • Parkinson's Disease (PD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Boston University Charles River Campus on 2026-08-24.