About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
< 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)
Trial design
Single group
Treatments tested in this trial
MR-005 (MedRhythms, Inc., Portland, ME)
DeviceMR-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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Boston University Charles River Campus
Lead sponsor
Michael J. Fox Foundation for Parkinson's Research
Collaborator
University of Utah
Collaborator
Washington University School of Medicine
Collaborator