<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/NCT03227718</url>
  </required_header>
  <id_info>
    <org_study_id>HM20008030</org_study_id>
    <nct_id>NCT03227718</nct_id>
  </id_info>
  <brief_title>VOR Suppression in Non-Gymnast Adults</brief_title>
  <official_title>VOR Suppression in Non-Gymnast Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Commonwealth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Virginia Commonwealth University</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 researchers hypothesize that there is a correlation between Vestibulo-ocular reflex (VOR)&#xD;
      performance and innate athletic skill level. A similar study was conducted in female, young&#xD;
      adult gymnasts where a correlation was shown between VOR performance and gymnastic skill&#xD;
      level. However, the results from this study did not suggest that VOR differences develop as a&#xD;
      result of practice; rather that the differences in VOR may simply allow some individuals to&#xD;
      become better performers. In this study the researchers would like to extend the population&#xD;
      to adults both with and without a background in gymnastics to determine the natural&#xD;
      relationship between VOR and innate athletic potential.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sports like gymnastics, diving, and ice skating often involve rotational elements with high&#xD;
      angular velocities. Many of these are airborne skills and have a significant element of risk.&#xD;
      The athletes who perform these skills have to rely on sensory information from the visual and&#xD;
      vestibular systems. It has been suggested that the vestibular system adapts to these types of&#xD;
      inputs and the athlete no longer experiences dizziness associated with multiple rotations.&#xD;
&#xD;
      A recent Neuroscience abstract described a small study of the directional selectivity of&#xD;
      vestibular habituation adult professional figure skaters. The results showed that figure&#xD;
      skaters demonstrated a profound reduction in the magnitude of post-rotary nystagmus and&#xD;
      caloric test response in their preferred direction of rotation. It was suggested that this&#xD;
      sensitivity was a result of &quot;habituation.&quot; The authors implied that the skaters learned to&#xD;
      suppress vestibular receptors on the side that they turned toward. This deduction is based on&#xD;
      patients that develop pathology on one side and learn to suppress the sensation on that side.&#xD;
      However, we do not currently know if the developing vestibular system works the same way or&#xD;
      if this is an inherited trait. Most of these athletes started as children, when their&#xD;
      vestibular system was still developing, and may have a more fine-tuned vestibular system and&#xD;
      be able to suppress certain reflexes. On the other hand, it could be that some people are&#xD;
      born with the ability to suppress this sensation, thus allowing them to become elite&#xD;
      athletes. Currently there isn't a defined relationship between a person's athleticism or&#xD;
      athletic upbringing and their vestibular system performance.&#xD;
&#xD;
      A major component of vestibular performance is the Vestibular Ocular Reflex (VOR). The VOR is&#xD;
      responsible for stabilizing the visual field on the retina during head movement. To&#xD;
      accomplish this, the eyes are reflexively moved in a direction opposite the head. For&#xD;
      example, in a twisting gymnast, this actually reduces the ability of gymnasts to see the&#xD;
      landing during airborne skills. Hence, it becomes necessary for gymnasts to cancel or&#xD;
      suppress their VOR in order to view the landing. A previous study conducted by the&#xD;
      researchers determined that young, actively practicing gymnasts (mean age 15±2.2) had a&#xD;
      higher ability to suppress their VOR than non-gymnasts of the same age. This previous study&#xD;
      determined that there is a correlation between VOR performance and gymnastic skill level.&#xD;
      However, these results do not suggest that the VOR differences develop as a result of&#xD;
      practice.&#xD;
&#xD;
      This study aims to establish a relationship between VOR performance and athleticism. By&#xD;
      comparing ex-gymnast adults (ages 18-30), and their age-matched, non-gymnast counterparts to&#xD;
      the previous study results involving actively practicing, child gymnasts, a relationship&#xD;
      between VOR performance and athletic skill can be determined. Furthermore, examining the VOR&#xD;
      data collected from this study to data collected from tests aimed at determining athleticism,&#xD;
      or a person's athletic potential, it may be possible to relate VOR performance to athletic&#xD;
      skill; In other words, determining whether athletes are successful because their vestibular&#xD;
      performance is superior to those whom are non-athletes, or it is a learned skill with&#xD;
      practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">April 18, 2017</completion_date>
  <primary_completion_date type="Actual">April 18, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>vestibulo-ocular reflex (VOR) gain</measure>
    <time_frame>2 hour data collection period (Visit 1)</time_frame>
    <description>amplitude of head v. eye velocities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>NASA Task Load Index</measure>
    <time_frame>Immediately after 2 hour data collection period (Visit 1)</time_frame>
    <description>measure of cognitive load during task performance</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Vestibular</condition>
  <condition>Performance</condition>
  <arm_group>
    <arm_group_label>athletic background</arm_group_label>
    <description>ex-gymnasts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>age-matched non-gymnastics background</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VOR and coordination measurements</intervention_name>
    <description>measurement of VOR and VOR suppression in addition to hand-eye coordination tasks</description>
    <arm_group_label>athletic background</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 12 adults (6 ex-gymnastics, and 6 age matched, non-gymnast counterparts),&#xD;
        ages 18-30 will be obtained via a sample of convenience from the University community.&#xD;
        Subjects will be asked to wear a measurement system (Eyelink II, SR Research) that tracks&#xD;
        head and eye movements as they perform as set of eye and head movements to measure saccadic&#xD;
        eye movements, VOR and VOR suppression. Periodic calibrations will be performed throughout&#xD;
        the experiment to test the continued reliability of the data.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal, adults will be recruited from the University community via a sample of&#xD;
             convenience.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children under the age of 18.&#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>Peter Pidcoe, PT, DPT, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Commonwealth University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</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>June 8, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>October 25, 2017</last_update_submitted>
  <last_update_submitted_qc>October 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>VOR</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03227718
org study id: HM20008030
nct id: NCT03227718
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The researchers hypothesize that there is a correlation between Vestibulo-ocular reflex (VOR)
      performance and innate athletic skill level. A similar study was conducted in female, young
      adult gymnasts where a correlation was shown between VOR performance and gymnastic skill
      level. However, the results from this study did not suggest that VOR differences develop as a
      result of practice; rather that the differences in VOR may simply allow some individuals to
      become better performers. In this study the researchers would like to extend the population
      to adults both with and without a background in gymnastics to determine the natural
      relationship between VOR and innate athletic potential.
Sports like gymnastics, diving, and ice skating often involve rotational elements with high
      angular velocities. Many of these are airborne skills and have a significant element of risk.
      The athletes who perform these skills have to rely on sensory information from the visual and
      vestibular systems. It has been suggested that the vestibular system adapts to these types of
      inputs and the athlete no longer experiences dizziness associated with multiple rotations.

      A recent Neuroscience abstract described a small study of the directional selectivity of
      vestibular habituation adult professional figure skaters. The results showed that figure
      skaters demonstrated a profound reduction in the magnitude of post-rotary nystagmus and
      caloric test response in their preferred direction of rotation. It was suggested that this
      sensitivity was a result of "habituation." The authors implied that the skaters learned to
      suppress vestibular receptors on the side that they turned toward. This deduction is based on
      patients that develop pathology on one side and learn to suppress the sensation on that side.
      However, we do not currently know if the developing vestibular system works the same way or
      if this is an inherited trait. Most of these athletes started as children, when their
      vestibular system was still developing, and may have a more fine-tuned vestibular system and
      be able to suppress certain reflexes. On the other hand, it could be that some people are
      born with the ability to suppress this sensation, thus allowing them to become elite
      athletes. Currently there isn't a defined relationship between a person's athleticism or
      athletic upbringing and their vestibular system performance.

      A major component of vestibular performance is the Vestibular Ocular Reflex (VOR). The VOR is
      responsible for stabilizing the visual field on the retina during head movement. To
      accomplish this, the eyes are reflexively moved in a direction opposite the head. For
      example, in a twisting gymnast, this actually reduces the ability of gymnasts to see the
      landing during airborne skills. Hence, it becomes necessary for gymnasts to cancel or
      suppress their VOR in order to view the landing. A previous study conducted by the
      researchers determined that young, actively practicing gymnasts (mean age 15±2.2) had a
      higher ability to suppress their VOR than non-gymnasts of the same age. This previous study
      determined that there is a correlation between VOR performance and gymnastic skill level.
      However, these results do not suggest that the VOR differences develop as a result of
      practice.

      This study aims to establish a relationship between VOR performance and athleticism. By
      comparing ex-gymnast adults (ages 18-30), and their age-matched, non-gymnast counterparts to
      the previous study results involving actively practicing, child gymnasts, a relationship
      between VOR performance and athletic skill can be determined. Furthermore, examining the VOR
      data collected from this study to data collected from tests aimed at determining athleticism,
      or a person's athletic potential, it may be possible to relate VOR performance to athletic
      skill; In other words, determining whether athletes are successful because their vestibular
      performance is superior to those whom are non-athletes, or it is a learned skill with
      practice.
observational model: Cohort
time perspective: Prospective
measure: vestibulo-ocular reflex (VOR) gain
time frame: 2 hour data collection period (Visit 1)
description: amplitude of head v. eye velocities
measure: NASA Task Load Index
time frame: Immediately after 2 hour data collection period (Visit 1)
description: measure of cognitive load during task performance
arm group label: athletic background
description: ex-gymnasts
arm group label: control
description: age-matched non-gymnastics background
intervention type: Behavioral
intervention name: VOR and coordination measurements
description: measurement of VOR and VOR suppression in addition to hand-eye coordination tasks
arm group label: athletic background
arm group label: control
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: Peter Pidcoe, PT, DPT, Ph.D.
role: Principal Investigator
affiliation: Virginia Commonwealth University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No