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Completed

NCT Number: NCT03660605

Priming Through Timing. Using Opposing Strategies to Enhance Motor Learning for Individuals With Parkinson's Disease

The purpose of this study is to determine how using auditory cues of a metronome at various frequencies impacts the gait mechanics and balance in people with Parkinson's disease when walking over ground and on a treadmill. We will enroll 10 participants with a diagnosis of Parkinson's disease (Stages 2 or 3). All participants will complete 18 training sessions over 6 weeks and participate in pre- and post-testing of gait and balance.

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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: No

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

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 ~6 minutes overground as well as walk on a treadmill for a total of 10 minutes with rest breaks as needed, and be classified as Stage 2, or 3 on the Hoehn and Yahr Scale (Goetz et. al, 2004).

Exclusion criteria

  • Exclusion criteria include Hoehn and Yahr Stages 1, 4, or 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

Rhythmic Auditory Stimulation

Other

Participants will complete 6 weeks of walking training (3x/week). During each session, participants will walk on a treadmill for up to 20 minutes (stepping to a metronome at 85% of typical cadence) followed by overground walking for up to 15 minutes (stepping to a metronome at 115% of typical cadence).

Primary outcomes

  1. gait speed

    Time frame: one week following conclusion of training

    distance traveled during a 6 minute walk test

Secondary outcomes

  1. cadence

    Time frame: one week following conclusion of training

    number of steps per minute

  2. stride length

    Time frame: one week following conclusion of training

    average length of strides (distance traveled/number of strides)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Priming Through Timing. Using Opposing Strategies to Enhance Motor Learning for Improved Gait in Individuals With Parkinson's Disease

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2018
Registry last updated
Nov 13, 2019

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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