<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/NCT01661075</url>
  </required_header>
  <id_info>
    <org_study_id>7419_2</org_study_id>
    <nct_id>NCT01661075</nct_id>
  </id_info>
  <brief_title>Quantification of Balance in Acutely Concussed Athletes</brief_title>
  <official_title>Quantification of Balance in Acutely Concussed Athletes, Implications for Return to Play Determination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Research Resources (NCRR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot project is to determine whether using inertial sensors placed on&#xD;
      the waist during routine clinical balance testing (i.e. Balance Error Scoring System) (BESS),&#xD;
      will be a more immediate, objective, reliable and sensitive way to measure and quantify&#xD;
      balance deficits in individuals with mild Traumatic Brain Injury (mTBI). The investigators&#xD;
      are also trying to observe if the sensors can be used to detect balance recovery after a&#xD;
      mTBI.&#xD;
&#xD;
      The investigators hypothesis is that collegiate atheltes with mTBI injury will have different&#xD;
      recovery periods between their cognitive testing(IMPACT) and their balance measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this pilot project is to determine whether using inertial sensors (ipod like&#xD;
      device) placed on the waist during routine clinical balance testing (i.e. Balance Error&#xD;
      Scoring System (BESS), will be a more immediate, objective, reliable and sensitive way to&#xD;
      measure and quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI).&#xD;
      The investigators are also trying to observe if the sensors can be used to detect balance&#xD;
      recovery after a mTBI.&#xD;
&#xD;
      The participants will be recruited through the local university's athletic department.&#xD;
&#xD;
      The participants will undergo balance tests from the BESS test while wearing a sensor around&#xD;
      their waist.The BESS consists of different balance tests; such as balancing on one leg and&#xD;
      tandem standing. The participants will also answer questionnaires about their daily lives and&#xD;
      cognitive tests. If the participant has had a mTBI they will complete questionnaires about&#xD;
      symptoms from their injury and may perform an additional IMPACT test which is a computerized&#xD;
      cognitive tests used by coaches, athletic trainers and managing physicians.&#xD;
&#xD;
      Along with the clinical balance tests and questionnaires, the project will use a small sensor&#xD;
      placed on the waist to detect sway during quiet stance. An automatic analysis will occur&#xD;
      which will provide us with immediate feedback on how stable the participant is during&#xD;
      testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">September 28, 2017</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Instrumented Modified Balance Error Scoring System</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>mTBI</condition>
  <condition>Concussion</condition>
  <condition>Mild Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>mTBI</arm_group_label>
    <description>These individuals will have had an mTBI during their respective collegiate athletic season.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <description>Recruitment of healthy controls who have not suffered an mTBI for balancing testing.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Collegiate atheltes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Collegiate athlete&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not a current collegiate athlete,&#xD;
&#xD;
          -  recent orthopedic surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurie A King, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Laurie King</investigator_full_name>
    <investigator_title>Assistant Profressor of Neurology</investigator_title>
  </responsible_party>
  <keyword>mTBI</keyword>
  <keyword>concussion</keyword>
  <keyword>mild traumatic brain injury</keyword>
  <keyword>athlete</keyword>
  <keyword>college</keyword>
  <keyword>football</keyword>
  <keyword>soccer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</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/NCT01661075
org study id: 7419_2
nct id: NCT01661075
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this pilot project is to determine whether using inertial sensors placed on
      the waist during routine clinical balance testing (i.e. Balance Error Scoring System) (BESS),
      will be a more immediate, objective, reliable and sensitive way to measure and quantify
      balance deficits in individuals with mild Traumatic Brain Injury (mTBI). The investigators
      are also trying to observe if the sensors can be used to detect balance recovery after a
      mTBI.

      The investigators hypothesis is that collegiate atheltes with mTBI injury will have different
      recovery periods between their cognitive testing(IMPACT) and their balance measures.
The purpose of this pilot project is to determine whether using inertial sensors (ipod like
      device) placed on the waist during routine clinical balance testing (i.e. Balance Error
      Scoring System (BESS), will be a more immediate, objective, reliable and sensitive way to
      measure and quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI).
      The investigators are also trying to observe if the sensors can be used to detect balance
      recovery after a mTBI.

      The participants will be recruited through the local university's athletic department.

      The participants will undergo balance tests from the BESS test while wearing a sensor around
      their waist.The BESS consists of different balance tests; such as balancing on one leg and
      tandem standing. The participants will also answer questionnaires about their daily lives and
      cognitive tests. If the participant has had a mTBI they will complete questionnaires about
      symptoms from their injury and may perform an additional IMPACT test which is a computerized
      cognitive tests used by coaches, athletic trainers and managing physicians.

      Along with the clinical balance tests and questionnaires, the project will use a small sensor
      placed on the waist to detect sway during quiet stance. An automatic analysis will occur
      which will provide us with immediate feedback on how stable the participant is during
      testing.
observational model: Ecologic or Community
time perspective: Prospective
measure: Instrumented Modified Balance Error Scoring System
time frame: 2 months
arm group label: mTBI
description: These individuals will have had an mTBI during their respective collegiate athletic season.
arm group label: healthy controls
description: Recruitment of healthy controls who have not suffered an mTBI for balancing testing.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laurie A King, PhD
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Laurie King
investigator title: Assistant Profressor of Neurology
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion