Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease

NCT ID: NCT05864157

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-16

Study Completion Date

2026-05-03

Brief Summary

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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

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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

Conditions

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Parkinson Disease

Keywords

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Gait Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The assessor will be blinded to group allocation

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Gait training without rhythmic auditory cues

Intervention Type OTHER

Gait training on treadmill and overground without any rhythmic auditory cues

Targeted Rhythmic Auditory Cueing (TRAC)

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).

Group Type EXPERIMENTAL

TRAC

Intervention Type OTHER

Metronome set to 85% on treadmill and 115% when walking overground

Distorted Targeted Rhythmic Auditory Cueing (dTRAC)

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).

Group Type EXPERIMENTAL

dTRAC

Intervention Type OTHER

Metronome set around 85% on treadmill and around 115% when walking overground

Interventions

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Gait training without rhythmic auditory cues

Gait training on treadmill and overground without any rhythmic auditory cues

Intervention Type OTHER

TRAC

Metronome set to 85% on treadmill and 115% when walking overground

Intervention Type OTHER

dTRAC

Metronome set around 85% on treadmill and around 115% when walking overground

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mike Lewek, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mike Lewek, PT, PhD

Role: CONTACT

Phone: 919-966-4041

Email: [email protected]

Facility Contacts

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Michael Lewek, PT, PhD

Role: primary

Other Identifiers

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R21HD111833

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-0021

Identifier Type: -

Identifier Source: org_study_id