<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03253965</url>
  </required_header>
  <id_info>
    <org_study_id>17-2089</org_study_id>
    <nct_id>NCT03253965</nct_id>
  </id_info>
  <brief_title>The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease</brief_title>
  <official_title>The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how using auditory cues of a metronome and music at&#xD;
      various frequencies impacts the gait mechanics in people with Parkinson's disease when&#xD;
      walking over ground and on a treadmill.&#xD;
&#xD;
      The investigators will enroll a total of 40 participants: 30 subjects with a diagnosis of&#xD;
      Parkinson's disease (10 in Stage 1, 10 in Stage 2, and 10 in Stage 3) and 10 unimpaired&#xD;
      subjects.&#xD;
&#xD;
      Participants will complete 7 different treadmill walking conditions and overground walking&#xD;
      conditions while the investigators measure step length, cadence, gait speed, and variability&#xD;
      of movement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Step Length</measure>
    <time_frame>The entire duration of each condition, approximately 2 minutes each.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cadence</measure>
    <time_frame>The entire duration of each condition, approximately 2 minutes each.</time_frame>
    <description>The number of steps taken per minute measured while walking on a treadmill or overground under each condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait speed</measure>
    <time_frame>The entire duration of each condition, approximately 2 minutes each.</time_frame>
    <description>The distance covered in a measured period of time (meters per second) while walking overground under each condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Movement variability</measure>
    <time_frame>The entire duration of each condition, approximately 2 minutes each.</time_frame>
    <description>The coefficient of variation of spatiotemporal measures (step timing and step length) while walking overground and on a treadmill under each condition.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Walking: Treadmill then Overground</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Walking: Overground, then Treadmill</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Metronome Normal</intervention_name>
    <description>Steps are timed with the beat of the metronome set to the subject's cadence</description>
    <arm_group_label>Walking: Overground, then Treadmill</arm_group_label>
    <arm_group_label>Walking: Treadmill then Overground</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Metronome Slow</intervention_name>
    <description>Steps are timed with the beat of the metronome set to 85% of the subject's cadence</description>
    <arm_group_label>Walking: Overground, then Treadmill</arm_group_label>
    <arm_group_label>Walking: Treadmill then Overground</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Metronome Fast</intervention_name>
    <description>Steps are timed with the beat of the metronome set to 115% of the subject's cadence</description>
    <arm_group_label>Walking: Overground, then Treadmill</arm_group_label>
    <arm_group_label>Walking: Treadmill then Overground</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music Normal</intervention_name>
    <description>Steps are timed with the beat of the music by a rhythm consistent with the subject's cadence</description>
    <arm_group_label>Walking: Overground, then Treadmill</arm_group_label>
    <arm_group_label>Walking: Treadmill then Overground</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music Slow</intervention_name>
    <description>Steps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence</description>
    <arm_group_label>Walking: Overground, then Treadmill</arm_group_label>
    <arm_group_label>Walking: Treadmill then Overground</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music Fast</intervention_name>
    <description>Steps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence</description>
    <arm_group_label>Walking: Overground, then Treadmill</arm_group_label>
    <arm_group_label>Walking: Treadmill then Overground</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Auditory cueing</intervention_name>
    <description>Steps are not timed with any auditory cue.</description>
    <arm_group_label>Walking: Overground, then Treadmill</arm_group_label>
    <arm_group_label>Walking: Treadmill then Overground</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        10 unimpaired controls and 30 subjects with Parkinson's Disease (described in detail below&#xD;
        - see inclusion/exclusion criteria). The 30 subjects with Parkinson's Disease will be&#xD;
        assigned into 3 groups (10 with H&amp;Y Stage 1, 10 with H&amp;Y Stage 2, and 10 with H&amp;Y Stage 3).&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with a diagnosis of Parkinson's Disease (made by movement disorders&#xD;
             specialist) will be included in this study. Additional inclusion criteria include:&#xD;
             self-reported ability to walk &gt;10 m overground as well as walk on a treadmill for a&#xD;
             total of 14 minutes with rest breaks as needed, and be classified as Stage 1, 2, or 3&#xD;
             on the Hoehn and Yahr Scale since these stages have the most independence with&#xD;
             mobility (Goetz et. al, 2004).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include Hoehn and Yahr Stage 4 and 5, uncontrolled&#xD;
             cardiorespiratory/metabolic disease (e.g., cardiac arrhythmia, uncontrolled&#xD;
             hypertension or diabetes, orthostatic hypertension, chronic emphysema), or other&#xD;
             neurological or orthopedic disorders that may affect walking. The investigators will&#xD;
             also exclude participants with severe communication impairments, which could impede&#xD;
             understanding of the purpose or procedures of the study or an inability to comply with&#xD;
             experimental procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guneet Chawla</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Lewek, PT, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>November 9, 2018</last_update_submitted>
  <last_update_submitted_qc>November 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03253965
org study id: 17-2089
nct id: NCT03253965
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Step Length
time frame: The entire duration of each condition, approximately 2 minutes each.
description: 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.
measure: Cadence
time frame: The entire duration of each condition, approximately 2 minutes each.
description: The number of steps taken per minute measured while walking on a treadmill or overground under each condition.
measure: Gait speed
time frame: The entire duration of each condition, approximately 2 minutes each.
description: The distance covered in a measured period of time (meters per second) while walking overground under each condition.
measure: Movement variability
time frame: The entire duration of each condition, approximately 2 minutes each.
description: The coefficient of variation of spatiotemporal measures (step timing and step length) while walking overground and on a treadmill under each condition.
arm group label: Walking: Treadmill then Overground
arm group type: Experimental
description: 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.
arm group label: Walking: Overground, then Treadmill
arm group type: Experimental
description: 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 type: Other
intervention name: Metronome Normal
description: Steps are timed with the beat of the metronome set to the subject's cadence
arm group label: Walking: Overground, then Treadmill
arm group label: Walking: Treadmill then Overground
intervention type: Other
intervention name: Metronome Slow
description: Steps are timed with the beat of the metronome set to 85% of the subject's cadence
arm group label: Walking: Overground, then Treadmill
arm group label: Walking: Treadmill then Overground
intervention type: Other
intervention name: Metronome Fast
description: Steps are timed with the beat of the metronome set to 115% of the subject's cadence
arm group label: Walking: Overground, then Treadmill
arm group label: Walking: Treadmill then Overground
intervention type: Other
intervention name: Music Normal
description: Steps are timed with the beat of the music by a rhythm consistent with the subject's cadence
arm group label: Walking: Overground, then Treadmill
arm group label: Walking: Treadmill then Overground
intervention type: Other
intervention name: Music Slow
description: Steps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence
arm group label: Walking: Overground, then Treadmill
arm group label: Walking: Treadmill then Overground
intervention type: Other
intervention name: Music Fast
description: Steps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence
arm group label: Walking: Overground, then Treadmill
arm group label: Walking: Treadmill then Overground
intervention type: Other
intervention name: No Auditory cueing
description: Steps are not timed with any auditory cue.
arm group label: Walking: Overground, then Treadmill
arm group label: Walking: Treadmill then Overground
criteria: 
gender: All
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Guneet Chawla
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Michael Lewek, PT, PhD
role: Study Chair
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease