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Completed

NCT Number: NCT03253965

The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease

The purpose of this study is to determine how using auditory cues of a metronome and music at various frequencies impacts the gait mechanics in people with Parkinson's disease when walking over ground and on a treadmill.

The investigators will enroll a total of 40 participants: 30 subjects with a diagnosis of Parkinson's disease (10 in Stage 1, 10 in Stage 2, and 10 in Stage 3) and 10 unimpaired subjects.

Participants will complete 7 different treadmill walking conditions and overground walking conditions while the investigators measure step length, cadence, gait speed, and variability of movement.

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Key information

Conditions

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

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

10 unimpaired controls and 30 subjects with Parkinson's Disease (described in detail below - see inclusion/exclusion criteria). The 30 subjects with Parkinson's Disease will be assigned into 3 groups (10 with H&Y Stage 1, 10 with H&Y Stage 2, and 10 with H&Y Stage 3).

Inclusion criteria

  • Individuals with a diagnosis of Parkinson's Disease (made by movement disorders specialist) will be included in this study. Additional inclusion criteria include: self-reported ability to walk >10 m overground as well as walk on a treadmill for a total of 14 minutes with rest breaks as needed, and be classified as Stage 1, 2, or 3 on the Hoehn and Yahr Scale since these stages have the most independence with mobility (Goetz et. al, 2004).

Exclusion criteria

  • Exclusion criteria include Hoehn and Yahr Stage 4 and 5, uncontrolled cardiorespiratory/metabolic disease (e.g., cardiac arrhythmia, uncontrolled hypertension or diabetes, orthostatic hypertension, chronic emphysema), or other neurological or orthopedic disorders that may affect walking. The investigators will also exclude participants with severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures.

Treatment and study plan

Metronome Normal

Other

Steps are timed with the beat of the metronome set to the subject's cadence

Metronome Slow

Other

Steps are timed with the beat of the metronome set to 85% of the subject's cadence

Metronome Fast

Other

Steps are timed with the beat of the metronome set to 115% of the subject's cadence

Music Normal

Other

Steps are timed with the beat of the music by a rhythm consistent with the subject's cadence

Music Slow

Other

Steps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence

Music Fast

Other

Steps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence

No Auditory cueing

Other

Steps are not timed with any auditory cue.

Primary outcomes

  1. Step Length

    Time frame: The entire duration of each condition, approximately 2 minutes each.

    The length of each step taken while walking on a treadmill or overground. It is the anteroposterior distance from one foot to the other at heel strike measured during walking under each condition.

Secondary outcomes

  1. Cadence

    Time frame: The entire duration of each condition, approximately 2 minutes each.

    The number of steps taken per minute measured while walking on a treadmill or overground under each condition.

  2. Gait speed

    Time frame: The entire duration of each condition, approximately 2 minutes each.

    The distance covered in a measured period of time (meters per second) while walking overground under each condition.

  3. Movement variability

    Time frame: The entire duration of each condition, approximately 2 minutes each.

    The coefficient of variation of spatiotemporal measures (step timing and step length) while walking overground and on a treadmill under each condition.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 18, 2017
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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