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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253965
• Other study ID #: 17-2089
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: November 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Metronome Normal
Steps are timed with the beat of the metronome set to the subject's cadence
• Metronome Slow
Steps are timed with the beat of the metronome set to 85% of the subject's cadence
• Metronome Fast
Steps are timed with the beat of the metronome set to 115% of the subject's cadence
• Music Normal
Steps are timed with the beat of the music by a rhythm consistent with the subject's cadence
• Music Slow
Steps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence
• Music Fast
Steps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence
• No Auditory cueing
Steps are not timed with any auditory cue.

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	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	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.
Secondary	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.
Secondary	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.