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Parkinson DiseaseNCT05864157

Targeted Motor Learning to Improve Gait for Individuals With Parkinson Disease

A study testing Gait training without rhythmic auditory cues, TRAC and dTRAC in people with Parkinson Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Gait training without rhythmic auditory cues, TRAC and dTRAC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
16 Aug 2023to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mike Lewek, PT, PhD contact

919-966-4041

mlewek@med.unc.edu

United States1 site, 1 recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Michael Lewek, PT, PhD

    Recruiting

Other trials in United States

About this study

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.

Read the 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

Being tested
Gait training without rhythmic auditory cues, TRAC, dTRAC
Keywords
Gait, Rehabilitation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gait training without rhythmic auditory cuesOther

    Gait training on treadmill and overground without any rhythmic auditory cues

  • TRACOther

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

  • dTRACOther

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

Study groups in NCT05864157
Study groupRoleWhat they receive
ControlActive comparatorParticipants will perform walking practice on a treadmill and overground without the use of a metronome.
Receives: Other: Gait training without rhythmic auditory cues
Targeted Rhythmic Auditory Cueing (TRAC)ExperimentalParticipants 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).
Receives: Other: TRAC
Distorted Targeted Rhythmic Auditory Cueing (dTRAC)ExperimentalParticipants 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).
Receives: Other: dTRAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 3 month follow-up

Secondary outcomes (8)

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

    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.

    Measured: baseline, 4 weeks

  2. Walking stride length

    The walking stride length represents the average stride length (distance between where one foot strikes the ground to the location that the same foot strikes the ground to complete the stride). The distance is measured from walking over a pressure mat during the 6MWT. This measurement will be completed at baseline (prior to training), after 4 weeks of training, and again for a 3 month follow-up. A larger value represents longer steps, and a better outcome.

    Measured: up to 3 month follow-up

  3. Walking Cadence

    Walking cadence is the frequency of steps per minute (inverse of step time). The average cadence is measured from passes over a pressure mat during the 6MWT, and will be completed at baseline (prior to training), after 4 weeks of training, and again for a 3 month follow-up.

    Measured: up to 3 month follow-up

  4. Gait interruption index

    The Gait Interruption Index represents the number of 'freezes' observed, divided by the number of 'freeze opportunities' (i.e., turns, times stepping on/off pressure mat) completed during the 6MWT. A higher number represents greater impairment in Freezing of Gait. This measurement will be completed at baseline (prior to training), after 4 weeks of training, and again for a 3 month follow-up.

    Measured: up to 3 month follow-up

  5. Mini BESTest (Balance Evaluation Systems Test) score

    The mini-BESTest is a 14-item, clinical battery used to assess balance in four component areas (anticipatory transitions, postural response, sensory orientation and dynamic gait) and provides a single number summary of balance performance. Scores range from 0 to 28 with higher scores indicate higher function.

    Measured: up to 3 month follow-up

  6. Freezing of Gait Questionnaire score

    The Freezing of Gait Questionnaire assesses freezing of gait (FOG) severity unrelated to falls in patients with Parkinson disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects. The total score ranges from 0-24, with higher scores representing greater severity of FOG symptoms.

    Measured: up to 3 month follow-up

  7. Hippocampal volume

    Hippocampal volume represents the size of the hippocampus, which is a portion of the deep brain. In particular, the investigators will compute the three dimensional volume of the hippocampus from structural MRI (Magnetic Resonance Imaging) taken at baseline and after 4 weeks of training.

    Measured: up to 4 weeks

  8. Fractional anisotropy

    Fractional anisotropy (FA) is derived from diffusion tensor imaging (DTI) sequences taken during the neuroimaging testing. FA reflects a ratio of the directional flows of water molecules within axonal bundles.

    Measured: up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start16 Aug 2023
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05864157
Sponsor's protocol ID
23-0021
Other IDs
R21HD111833
Status last verified
Jun 2026
First submitted
8 May 2023
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data collected will be shared with other researchers. Specifically, the investigators will share all individual level 6MWT distances, average cadence, stride length, and gait interruption indices from the baseline test, after 4 weeks of training, and at the 3 month follow-up. All MiniBESTtest total scores, and FOGQ total scores from these timepoints will also be shared for each individual. Finally, the investigators will share hippocampal volume and fractional anisotropy values from each participant taken at baseline and after four weeks of training.

Questions about this trial

What is this clinical trial studying?

A study testing Gait training without rhythmic auditory cues, TRAC and dTRAC in people with Parkinson Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mike Lewek, PT, PhD (919-966-4041, mlewek@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Six minute walk test (6MWT) at the 3 month follow up visit (time frame: Baseline, 3 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05864157.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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