NCT05864157 Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease
| NCT ID | NCT05864157 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2023-08-16 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2023-08-16 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to determine how training to step with a metronome on both a treadmill, as well as overground, will influence the way that people with Parkinson disease walk. Using metronomes is commonly used in clinics, but the investigators will be using a combination of slow and fast frequencies to alter the way that people walk. The use of a slower frequency metronome on the treadmill is intended to help participants take larger steps. The use of a faster frequency metronome while walking overground is intended to help participants take faster steps.This will take place over 12 training sessions. Each session will be about an hour. It will include some walking tests and pictures of the brain (using MRI) before and after training.
Eligibility Criteria
Inclusion Criteria: * idiopathic Parkinson's disease (Hoehn and Yahr Stage 2-3) * self-report the ability to walk uninterrupted for 10 minutes both overground and on a treadmill without therapist assistance * comfortable gait speed \> 0.4 m/s and \< 1.2 m/s * normal (or corrected to normal \[i.e., hearing aid\]) hearing * deficits in gait continuity (e.g., shuffling, shortened strides, freezing, festination, bradykinesia, etc) based on observational gait analysis * Movement Disorders Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS-III) item 10 ≥1 and \<3 * be on stable doses of orally-administered levodopa * age 50-80 years old Exclusion Criteria: * contraindications to MRI (e.g., metal implants, claustrophobia, etc) * cognitive deficits (Montreal Cognitive Assessment \[MoCA\] \< 26) * concurrent Physical Therapy * have undergone deep brain stimulation surgery * cannot walk without therapist assistance * uncontrolled cardiorespiratory/metabolic disease, or other neurological disorders or orthopedic injury that may affect gait.
Contact & Investigator
Mike Lewek, PT, PhD
PRINCIPAL INVESTIGATOR
Associate Professor
Frequently Asked Questions
Who can join the NCT05864157 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05864157 currently recruiting?
Yes, NCT05864157 is actively recruiting participants. Contact the research team at mlewek@med.unc.edu for enrollment information.
Where is the NCT05864157 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT05864157 clinical trial?
NCT05864157 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Mike Lewek, PT, PhD at Associate Professor. The trial plans to enroll 45 participants.
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