NCT07705373 · Boston University Charles River Campus
A Novel Digital Music-based Autonomous Personalized Walking Intervention to Improve Gait and Walking Automaticity in Parkinson Disease
(MyMusiQ)
What this study is about
The purpose of this research study is to examine the effects of a 3-month personalized community-based walking program called MyMusiQ. The study uses music cues delivered through a digital device in people with Parkinson disease (PD).
View original scientific description
The purpose of this research study is to examine the effects of a 3-month personalized community-based walking program called MyMusiQ. The study uses music cues delivered through a digital device in people with Parkinson disease (PD). 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.
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.
Primary outcome measures
Minutes of Moderate Intensity Walking
Time frame: Baseline 1
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
Time frame: Baseline 2 (2-3 weeks after Baseline 1)
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
Time frame: Immediately after the intervention (about 3 months)
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
Time frame: Follow-Up (about 1 month post-intervention)
The amount of moderate intensity walking, defined as mean number of minutes per day with \>100 steps/min, measured using research-grade wearable sensors.
Daily Step Counts
Time frame: Baseline 1
Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.
Daily Step Counts
Time frame: Baseline 2 (2-3 weeks after Baseline 1)
Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.
Daily Step Counts
Time frame: Immediately after the intervention (about 3 months)
Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.
Daily Step Counts
Time frame: Follow-Up (about 1 month post-intervention)
Daily step counts refer to the number of steps taken per day. This will be measured using research-grade activity monitors validated for use in PD.
6-Minute Walk Test
Time frame: Baseline 1
This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.
6-Minute Walk Test
Time frame: Baseline 2 (2-3 weeks after Baseline 1)
This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.
6-Minute Walk Test
Time frame: Immediately after the intervention (about 3 months)
This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.
6-Minute Walk Test
Time frame: Follow-Up (about 1 month post-intervention)
This is a test of long-distance walking capacity. The participant will be asked to "cover as much distance as they safely can" for 6 minutes. Total distance (m) is the main metric, with greater distance indicating greater walking capacity.
Gait Speed
Time frame: Baseline 1
Gait speed (m/s) will be measured using research-grade wearable sensors.
Gait Speed
Time frame: Baseline 2 (2-3 weeks after Baseline 1)
Gait speed (m/s) will be measured using research-grade wearable sensors.
Gait Speed
Time frame: Immediately after the intervention (about 3 months)
Gait speed (m/s) will be measured using research-grade wearable sensors.
Gait Speed
Time frame: Follow-Up (about 1 month post-intervention)
Gait speed (m/s) will be measured using research-grade wearable sensors.
Stride Length
Time frame: Baseline 1
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Stride Length
Time frame: Baseline 2 (2-3 weeks after Baseline 1)
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Stride Length
Time frame: Immediately after the intervention (about 3 months)
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Stride Length
Time frame: Follow-Up (about 1 month post-intervention)
Quantified metrics of stride length (m) will be collected using research-grade wearable sensors.
Variability of Stride Time
Time frame: Baseline 1
Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.
Variability of Stride Time
Time frame: Baseline 2 (2-3 weeks after Baseline 1)
Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.
Variability of Stride Time
Time frame: Immediately after the intervention (about 3 months)
Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.
Variability of Stride Time
Time frame: Follow-Up (about 1 month post-intervention)
Stride-to-stride variability of stride time of the gait cycle will be measured using research-grade wearable sensors. Stride time variability is calculated by dividing the standard deviation of stride time by the mean of stride time, multiplied by 100 to express as a percentage.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
- St Louis, Missouri
- Salt Lake City, Utah
Collaborators
Michael J. Fox Foundation for Parkinson's Research, University of Utah, Washington University School of Medicine
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 24, 2026 · Source of record for eligibility and locations