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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03660605
Other study ID # 18-2043
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2018
Est. completion date September 15, 2019

Study information

Verified date November 2019
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date September 15, 2019
Est. primary completion date September 15, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary gait speed distance traveled during a 6 minute walk test one week following conclusion of training
Secondary cadence number of steps per minute one week following conclusion of training
Secondary stride length average length of strides (distance traveled/number of strides) one week following conclusion of training
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