Parkinson's Disease study: MR-005
Official title A Novel Digital Music-based Autonomous Personalized Walking Intervention to Improve Gait and Walking Automaticity in Parkinson Disease
ClinicalTrials.gov ID: NCT07705373
What this study is testing
- What it's testing
- This study wants to see if using personalized music cues from a digital device can improve how people with Parkinson's walk. It also aims to find out if this method helps walking feel more automatic and less mentally tiring.
- Who it's for
- The study is looking for people who have been diagnosed with Parkinson's disease.
- What's involved
- Participants will use a digital device that plays music to guide their walking. They will follow a personalized walking program at home for three months.
- Time commitment
- The study lasts about 18 weeks and requires four visits to a research center.
- Time commitment: about 18 weeks
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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
You likely can't join if
- \< 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
See the full eligibility 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
- \< 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
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 18 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States; St Louis, Missouri, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.