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NCT05864157 | RECRUITING | Parkinson Disease

Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease
Sponsor:

University of North Carolina, Chapel Hill

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.

Condition or disease

Parkinson Disease

Intervention/treatment

Gait training without rhythmic auditory cues

TRAC

dTRAC

Phase

NA

Detailed Description:

Some details regarding the metronome frequency are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete

Study Type : INTERVENTIONAL
Estimated Enrollment : 45 participants
Masking : SINGLE
Masking Description : The assessor will be blinded to group allocation
Primary Purpose : TREATMENT
Official Title : Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease
Actual Study Start Date : 2023-08-16
Estimated Primary Completion Date : 2026-05-01
Estimated Study Completion Date : 2026-05-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease

Location Details

NCT05864157

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Locations

RECRUITING

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599