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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits
  • Time periods mentioned: 18 weeks, 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a 3-month walking program for people age 40 or older with Parkinson disease. A digital device gives personalized music cues to see if they help people walk better, with less mental effort, and improve quality of life. Taking part lasts about 18 weeks and includes 4 visits at a study center.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You report that a medical doctor diagnosed you with typical Parkinson disease.
  • You are age 40 or older.
  • You live in the community, such as at home, in independent living, or in senior housing.
  • Your Parkinson medicines have been stable for at least 2 weeks before joining.
  • A physical therapist rates your Parkinson disease as stage 1–3 on the study’s severity scale.
  • You can walk for at least 10 minutes without another person’s help. Walking aids are allowed if you step with alternating feet.
  • You are willing and able to give informed consent, meaning you understand and agree to join.
  • You give privacy permission for the study team to contact your main healthcare provider as needed.

Who can't join

  • You are under 40, have atypical parkinsonism (a condition like Parkinson disease), or have stage 4–5 Parkinson disease.
  • Your feet often feel stuck to the ground during daily walking in a way that greatly disrupts walking, or you averaged more than 1 fall per week over the past month.
  • You are getting physical therapy for Parkinson-related walking problems, or you already do moderate or harder walking exercise for at least 30 minutes, 3 or more times a week.
  • You have heart problems that make exercise unsafe; leg, hip, or spine problems that limit walking; or another health condition the study team says would prevent participation.
  • You score below 21 on the MoCA, a test of memory and thinking.
  • You cannot walk without another person’s help at a comfortable speed of at least 0.4 meters per second on the study’s walking test.
  • At rest, your heart rate is over 100 beats per minute, or your blood pressure’s top number is over 160 or bottom number is over 100.
  • You cannot use the music device on your own during training, or you have major hearing loss.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (3)

MA

MO

UT