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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorBoston University Charles River Campus

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

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

    Device

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: MyMusiQ (MMQ) Walking interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline 1
2

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.

Time frame
Baseline 2 (2-3 weeks after Baseline 1)
3

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.

Time frame
Immediately after the intervention (about 3 months)
4

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.

Time frame
Follow-Up (about 1 month post-intervention)

Secondary outcomes

1

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.

Time frame
Baseline 1
2

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.

Time frame
Baseline 2 (2-3 weeks after Baseline 1)
3

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.

Time frame
Immediately after the intervention (about 3 months)
4

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.

Time frame
Follow-Up (about 1 month post-intervention)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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