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Clinical Trials/NCT03253965
NCT03253965CompletedNot Applicable

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

University of North Carolina, Chapel Hill1 site in 1 country21 target enrollmentStarted: September 15, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Step Length

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion 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.

Arms & Interventions

Walking: Treadmill then Overground

Experimental

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: Metronome Normal (Other)

Walking: Treadmill then Overground

Experimental

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: Metronome Slow (Other)

Walking: Treadmill then Overground

Experimental

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: Metronome Fast (Other)

Walking: Treadmill then Overground

Experimental

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: Music Normal (Other)

Walking: Treadmill then Overground

Experimental

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: Music Slow (Other)

Walking: Treadmill then Overground

Experimental

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: Music Fast (Other)

Walking: Treadmill then Overground

Experimental

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: No Auditory cueing (Other)

Walking: Overground, then Treadmill

Experimental

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: Metronome Normal (Other)

Walking: Overground, then Treadmill

Experimental

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: Metronome Slow (Other)

Walking: Overground, then Treadmill

Experimental

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: Metronome Fast (Other)

Walking: Overground, then Treadmill

Experimental

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: Music Normal (Other)

Walking: Overground, then Treadmill

Experimental

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: Music Slow (Other)

Walking: Overground, then Treadmill

Experimental

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: Music Fast (Other)

Walking: Overground, then Treadmill

Experimental

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: No Auditory cueing (Other)

Outcomes

Primary Outcomes

Step Length

Time Frame: The entire duration of each condition, approximately 2 minutes each.

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 Outcomes

  • Gait speed(The entire duration of each condition, approximately 2 minutes each.)
  • Cadence(The entire duration of each condition, approximately 2 minutes each.)
  • Movement variability(The entire duration of each condition, approximately 2 minutes each.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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