Back to resultsThe Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metronome Normal
Metronome Slow
Metronome Fast
Music Normal
Music Slow
Music Fast
No Auditory cueing
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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.
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Walking: Treadmill then Overground
Walking: Overground, then Treadmill
Arm Description
Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.
Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.
Outcomes
Primary Outcome Measures
Step Length
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 Outcome Measures
Cadence
The number of steps taken per minute measured while walking on a treadmill or overground under each condition.
Gait speed
The distance covered in a measured period of time (meters per second) while walking overground under each condition.
Movement variability
The coefficient of variation of spatiotemporal measures (step timing and step length) while walking overground and on a treadmill under each condition.
Full Information
NCT ID
NCT03253965
First Posted
August 11, 2017
Last Updated
November 9, 2018
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT03253965
Brief Title
The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease
Official Title
The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walking: Treadmill then Overground
Arm Type
Experimental
Arm Description
Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.
Arm Title
Walking: Overground, then Treadmill
Arm Type
Experimental
Arm Description
Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing.
Intervention Type
Other
Intervention Name(s)
Metronome Normal
Intervention Description
Steps are timed with the beat of the metronome set to the subject's cadence
Intervention Type
Other
Intervention Name(s)
Metronome Slow
Intervention Description
Steps are timed with the beat of the metronome set to 85% of the subject's cadence
Intervention Type
Other
Intervention Name(s)
Metronome Fast
Intervention Description
Steps are timed with the beat of the metronome set to 115% of the subject's cadence
Intervention Type
Other
Intervention Name(s)
Music Normal
Intervention Description
Steps are timed with the beat of the music by a rhythm consistent with the subject's cadence
Intervention Type
Other
Intervention Name(s)
Music Slow
Intervention Description
Steps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence
Intervention Type
Other
Intervention Name(s)
Music Fast
Intervention Description
Steps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence
Intervention Type
Other
Intervention Name(s)
No Auditory cueing
Intervention Description
Steps are not timed with any auditory cue.
Primary Outcome Measure Information:
Title
Step Length
Description
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.
Time Frame
The entire duration of each condition, approximately 2 minutes each.
Secondary Outcome Measure Information:
Title
Cadence
Description
The number of steps taken per minute measured while walking on a treadmill or overground under each condition.
Time Frame
The entire duration of each condition, approximately 2 minutes each.
Title
Gait speed
Description
The distance covered in a measured period of time (meters per second) while walking overground under each condition.
Time Frame
The entire duration of each condition, approximately 2 minutes each.
Title
Movement variability
Description
The coefficient of variation of spatiotemporal measures (step timing and step length) while walking overground and on a treadmill under each condition.
Time Frame
The entire duration of each condition, approximately 2 minutes each.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guneet Chawla
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Lewek, PT, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Chair
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease
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