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

November 11, 2019 updated by: University of North Carolina, Chapel Hill

Priming Through Timing. Using Opposing Strategies to Enhance Motor Learning for Improved Gait in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rhythmic Auditory Stimulation
Participants will walk on treadmill to metronome set at 85% of typical cadence, followed by overground walking with metronome set at 115% of typical cadence.
Other: Rhythmic Auditory Stimulation
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gait speed
Time Frame: one week following conclusion of training
distance traveled during a 6 minute walk test
one week following conclusion of training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cadence
Time Frame: one week following conclusion of training
number of steps per minute
one week following conclusion of training
stride length
Time Frame: one week following conclusion of training
average length of strides (distance traveled/number of strides)
one week following conclusion of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Michael Lewek, PT, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2018

Primary Completion (Actual)

September 15, 2019

Study Completion (Actual)

September 15, 2019

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 11, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-2043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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