Recruiting

Motor Learning

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT05864157

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Gait training without rhythmic auditory cues

TRAC

dTRAC

Study Details

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

Study ID

NCT05864157

Start date

Aug 16, 2023

Status verified date

Jun, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

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

experimental: 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).

experimental: 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).

Interventions

Gait training without rhythmic auditory cues

Gait training on treadmill and overground without any rhythmic auditory cues

TRAC

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

dTRAC

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

Primary outcome measure

  • Change in Six minute walk test (6MWT) at the 3 month follow up visit [ Time Frame: Baseline, 3 month follow-up ]

Central Contacts and Locations

Central contacts

Mike Lewek, PT, PhD

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

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Gait
  • Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-06-25.