Personalized music-guided walking for Parkinson’s disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a personalized, closed-loop music-based gait intervention (MR-005) in adults with Parkinson’s disease across multiple centers. It uses a 12-week, four-days-per-week home-walking program guided by a digital device delivering music cues to help gait automaticity and walking capacity. The trial is a single-arm, multi-center design enrolling up to 162 participants, after earlier feasibility and short-term trials. Outcomes focus on gait quality, real-world walking, and quality of life, with mechanistic aims to identify who responds best.

Why it matters

Who can join: the full rules

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

Where it's running

• Boston University Center for Neurorehabilitation
  Boston, Massachusetts, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Terry D. Ellis, PhD PT — Boston University Center for Neurorehabilitation
• Study coordinator: Erica Clarke, BS
• Email: egclarke@bu.edu
• Phone: 617-358-6157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.