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RECRUITING

NCT07705373

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

Sponsor: Boston University Charles River Campus

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-08-20

Completion Date

2029-02-28

Last Updated

2026-08-24

Healthy Volunteers

Conditions

Parkinson's Disease (PD)

Interventions

DEVICE

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.

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

Locations (3)

Boston University Center for Neurorehabilitation

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Utah

Salt Lake City, Utah, United States