The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Sep 2017
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2017
CompletedFirst Posted
Study publicly available on registry
August 18, 2017
CompletedStudy Start
First participant enrolled
September 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedNovember 13, 2018
November 1, 2018
11 months
August 11, 2017
November 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
The entire duration of each condition, approximately 2 minutes each.
Secondary Outcomes (3)
Cadence
The entire duration of each condition, approximately 2 minutes each.
Gait speed
The entire duration of each condition, approximately 2 minutes each.
Movement variability
The entire duration of each condition, approximately 2 minutes each.
Study Arms (2)
Walking: Treadmill then Overground
EXPERIMENTALWalking 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: Overground, then Treadmill
EXPERIMENTALWalking 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.
Interventions
Steps are timed with the beat of the metronome set to the subject's cadence
Steps are timed with the beat of the metronome set to 85% of the subject's cadence
Steps are timed with the beat of the metronome set to 115% of the subject's cadence
Steps are timed with the beat of the music by a rhythm consistent with the subject's cadence
Steps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence
Steps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence
Steps are not timed with any auditory cue.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guneet Chawla
University of North Carolina, Chapel Hill
- STUDY CHAIR
Michael Lewek, PT, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2017
First Posted
August 18, 2017
Study Start
September 15, 2017
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
November 13, 2018
Record last verified: 2018-11