Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease

NCT05864157 | Recruiting

• 2 other identifiers: 23-0021R21HD111833
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Gait; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Six minute walk test (6MWT) at the 3 month follow up visit

  The 6-minute walk test provides a more objective quantitative measure of mobility, functional performance, and symptom control. It measures the distance an individual can walk over a total of six minutes on a hard, flat surface. The individual can self-pace and rest as needed as they walk back and forth along a marked course. The participant can use an assistive walking device they normally use, such as a cane. The minimum clinically important difference in 6-minute walk distance is approximately 30 meters, a difference that is associated with mortality. A higher change score represents a greater improvement in walking function and a better outcome.

  Baseline, 3 month follow-up

Secondary Outcomes (8)

• Change in Six minute walk test (6MWT) after 4 weeks of training

  baseline, 4 weeks

• Walking stride length

  up to 3 month follow-up

• Walking Cadence

  up to 3 month follow-up

• Gait interruption index

  up to 3 month follow-up

• Mini BESTest (Balance Evaluation Systems Test) score

  up to 3 month follow-up

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Other: Gait training without rhythmic auditory cues

Targeted Rhythmic Auditory Cueing (TRAC)

EXPERIMENTAL

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).

Other: TRAC

Distorted Targeted Rhythmic Auditory Cueing (dTRAC)

EXPERIMENTAL

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).

Other: dTRAC

Interventions

Gait training without rhythmic auditory cues OTHER

Gait training on treadmill and overground without any rhythmic auditory cues

Control

TRAC OTHER

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

Targeted Rhythmic Auditory Cueing (TRAC)

dTRAC OTHER

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

Distorted Targeted Rhythmic Auditory Cueing (dTRAC)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Mike Lewek, PT, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike Lewek, PT, PhD

CONTACT

919-966-4041; mlewek@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 18, 2023
• Study Start: August 16, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 3, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Moreover, the investigators are committed to releasing all data, including neuroimaging, and scale data to the general scientific community, upon completion of the study. In particular, the investigators will use open platforms (e.g., UNC Dataverse) to disseminate data. Access to the data repository will be free of charge.

Locations

US (1)