Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease

University of North Carolina (UNC)

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: Gait training without rhythmic auditory cues; Other: dTRAC; Other: TRAC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05864157

23-0021

R21HD111833 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Control

Active Comparator group

Description:

Participants will perform walking practice on a treadmill and overground without the use of a metronome.

Treatment:

Other: Gait training without rhythmic auditory cues

Targeted Rhythmic Auditory Cueing (TRAC)

Experimental group

Description:

Participants will perform walking practice on a treadmill (with a metronome set to 85% of typical cadence) and overground (with a metronome set to 115% of typical cadence).

Treatment:

Other: TRAC

Distorted Targeted Rhythmic Auditory Cueing (dTRAC)

Experimental group

Description:

Participants will perform walking practice on a treadmill (with a metronome set around 85% of typical cadence) and overground (with a metronome set around 115% of typical cadence).

Treatment:

Other: dTRAC