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

ClinicalTrials.gov ID

NCT07705373

Lead Sponsor

Boston University Charles River CampusOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

200Estimated

Last Update Posted

Aug 24, 2026Actual

Start Date

Aug 20, 2026Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Feb 28, 2029Estimated

Official Title

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

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.

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.

• Parkinson's Disease (PD)

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Boston University Charles River CampusOTHER

Collaborators

Michael J. Fox Foundation for Parkinson's ResearchOTHER

University of UtahOTHER

Washington University School of MedicineOTHER

rheanna.anderson@utah.edu801-587-3615

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