Clinical trial NCT05864157: Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease
Official title: Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Gait
Rehabilitation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-05-18
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Change in Six minute walk test (6MWT) at the 3 month follow up visit
timeFrame: Baseline, 3 month follow-up
Secondary outcomes:
measure: Change in Six minute walk test (6MWT) after 4 weeks of training
timeFrame: baseline, 4 weeks
measure: Walking stride length
timeFrame: up to 3 month follow-up
measure: Walking Cadence
timeFrame: up to 3 month follow-up
measure: Gait interruption index
timeFrame: up to 3 month follow-up
measure: Mini BESTest (Balance Evaluation Systems Test) score
timeFrame: up to 3 month follow-up
measure: Freezing of Gait Questionnaire score
timeFrame: up to 3 month follow-up
measure: Hippocampal volume
timeFrame: up to 4 weeks
measure: Fractional anisotropy
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: Associate Professor
name: Mike Lewek, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: