Clinical trial NCT03253965: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Step Length
timeFrame: The entire duration of each condition, approximately 2 minutes each.
Secondary outcomes:
measure: Cadence
timeFrame: The entire duration of each condition, approximately 2 minutes each.
measure: Gait speed
timeFrame: The entire duration of each condition, approximately 2 minutes each.
measure: Movement variability
timeFrame: The entire duration of each condition, approximately 2 minutes each.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Guneet Chawla
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Michael Lewek, PT, PhD
role: STUDY_CHAIR
References: