The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Metronome Normal; Other: Metronome Slow; Other: Metronome Fast; Other: Music Normal; Other: Music Slow; Other: Music Fast; Other: No Auditory cueing

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walking: Treadmill then Overground; 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.	Other: Metronome Normal; Steps are timed with the beat of the metronome set to the subject's cadence; Other: Metronome Slow; Steps are timed with the beat of the metronome set to 85% of the subject's cadence; Other: Metronome Fast; Steps are timed with the beat of the metronome set to 115% of the subject's cadence; Other: Music Normal; Steps are timed with the beat of the music by a rhythm consistent with the subject's cadence; Other: Music Slow; Steps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence; Other: Music Fast; Steps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence; Other: No Auditory cueing; Steps are not timed with any auditory cue.
Experimental: Walking: Overground, then Treadmill; 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.	Other: Metronome Normal; Steps are timed with the beat of the metronome set to the subject's cadence; Other: Metronome Slow; Steps are timed with the beat of the metronome set to 85% of the subject's cadence; Other: Metronome Fast; Steps are timed with the beat of the metronome set to 115% of the subject's cadence; Other: Music Normal; Steps are timed with the beat of the music by a rhythm consistent with the subject's cadence; Other: Music Slow; Steps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence; Other: Music Fast; Steps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence; Other: No Auditory cueing; Steps are not timed with any auditory cue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cadence	The number of steps taken per minute measured while walking on a treadmill or overground under each condition.	The entire duration of each condition, approximately 2 minutes each.
Gait speed	The distance covered in a measured period of time (meters per second) while walking overground under each condition.	The entire duration of each condition, approximately 2 minutes each.
Movement variability	The coefficient of variation of spatiotemporal measures (step timing and step length) while walking overground and on a treadmill under each condition.	The entire duration of each condition, approximately 2 minutes each.

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Guneet Chawla, University of North Carolina, Chapel Hill; Study Chair: Michael Lewek, PT, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 17-2089

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No