<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/NCT03298139</url>
  </required_header>
  <id_info>
    <org_study_id>16-115</org_study_id>
    <nct_id>NCT03298139</nct_id>
  </id_info>
  <brief_title>THE INFLUENCE OF GRAVITY</brief_title>
  <acronym>ARGuide</acronym>
  <official_title>THE INFLUENCE OF GRAVITY ON TARGET CUEING DURING VISUAL SEARCH USING AUGMENTED REALITY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</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>
      Although most ground studies showed that an egocentric reference frame better supports&#xD;
      spatial orientation, it is not proven it will be the same during weightlessness.&#xD;
&#xD;
      Although it might justify that visuomotor performance will be better supported by egocentric&#xD;
      target cueing under altered gravity conditions, the fact that exocentric target cueing&#xD;
      induces less head movements and called for least attentional and physiological workload could&#xD;
      be the key factors for a more efficient task localization process. Moreover, weightlessness&#xD;
      can induce spatial disorientation, which can be additionally influenced by the intrinsic and&#xD;
      extrinsic spatial reference frames (Gurfinkel et al., 1993; Glasauer &amp; Mittelstädt, 1997,&#xD;
      1998; Harm et al., 1998; Lipshits et al. 2005). We expect that during weightlessness the&#xD;
      workload will be the key factor and thus we hypothesize that an exocentric target cueing will&#xD;
      outperform egocentric target cueing.&#xD;
&#xD;
      To test this hypothesis, and find out which presentation scheme for target cueing (EGO, EXO,&#xD;
      ED) contributes most to an efficient visual search, performance to a visuomotor task will be&#xD;
      evaluated during parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity&#xD;
      (0g). The visuomotor performance will be assessed by a multi-directional tapping task as&#xD;
      defined by ISO9241-9, which requests for motor responses by aimed pointing movements. Besides&#xD;
      analyzing the pointing performance, different workload indices will be additionally assessed&#xD;
      to evaluate the effort spent on visuomotor coordination. The attentional workload will be&#xD;
      evaluated by the performance of a secondary task (visual reaction-time task), which needs to&#xD;
      be conducted in parallel to the visuomotor task. Furthermore, the workload will be also&#xD;
      assessed subjectively by the NASA TLX rating scale and physiologically, by analyzing the&#xD;
      heart rate variability (HRV).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>visuomotor performance</measure>
    <time_frame>baseline</time_frame>
    <description>The visuomotor performance will be assessed by a multi-directional tapping task as defined by ISO9241-9, which requests for motor responses by aimed pointing movements.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>common external display guidance method (ED)</measure>
    <time_frame>baseline</time_frame>
    <description>common external display guidance method (ED) and exocentric &quot;in-view&quot; cueing (EXO), using common guidance method with an external display (ED) as a control condition</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>parabolic flights</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity (0g).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3 levels of gravity (1G, 1.8G, 0G).</intervention_name>
    <description>healthy volunteers will experience 3 levels of gravity (1G, 1.8G, 0G).</description>
    <arm_group_label>parabolic flights</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers (men or women)&#xD;
&#xD;
          -  Aged from 18 to 67&#xD;
&#xD;
          -  Affiliated to a Social Security system and, for non-French resident, holding a&#xD;
             European Health Insurance Card (EHIC)&#xD;
&#xD;
          -  Who accepted to take part in the study&#xD;
&#xD;
          -  Who have given their written stated consent&#xD;
&#xD;
          -  Who has passed a medical examination similar to a standard aviation medical&#xD;
             examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There&#xD;
             will be no additional test performed for subject selection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person who took part in a previous biomedical research protocol, of which exclusion&#xD;
             period is not terminated&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Pierre Denise, MD-PhD</last_name>
    <phone>+33 231.06.81.32</phone>
    <email>pierre.denise@unicaen.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre Denise</last_name>
      <email>pierre.denise@unicaen.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03298139
org study id: 16-115
nct id: NCT03298139
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although most ground studies showed that an egocentric reference frame better supports
      spatial orientation, it is not proven it will be the same during weightlessness.

      Although it might justify that visuomotor performance will be better supported by egocentric
      target cueing under altered gravity conditions, the fact that exocentric target cueing
      induces less head movements and called for least attentional and physiological workload could
      be the key factors for a more efficient task localization process. Moreover, weightlessness
      can induce spatial disorientation, which can be additionally influenced by the intrinsic and
      extrinsic spatial reference frames (Gurfinkel et al., 1993; Glasauer & Mittelstädt, 1997,
      1998; Harm et al., 1998; Lipshits et al. 2005). We expect that during weightlessness the
      workload will be the key factor and thus we hypothesize that an exocentric target cueing will
      outperform egocentric target cueing.

      To test this hypothesis, and find out which presentation scheme for target cueing (EGO, EXO,
      ED) contributes most to an efficient visual search, performance to a visuomotor task will be
      evaluated during parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity
      (0g). The visuomotor performance will be assessed by a multi-directional tapping task as
      defined by ISO9241-9, which requests for motor responses by aimed pointing movements. Besides
      analyzing the pointing performance, different workload indices will be additionally assessed
      to evaluate the effort spent on visuomotor coordination. The attentional workload will be
      evaluated by the performance of a secondary task (visual reaction-time task), which needs to
      be conducted in parallel to the visuomotor task. Furthermore, the workload will be also
      assessed subjectively by the NASA TLX rating scale and physiologically, by analyzing the
      heart rate variability (HRV).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
measure: visuomotor performance
time frame: baseline
description: The visuomotor performance will be assessed by a multi-directional tapping task as defined by ISO9241-9, which requests for motor responses by aimed pointing movements.
measure: common external display guidance method (ED)
time frame: baseline
description: common external display guidance method (ED) and exocentric "in-view" cueing (EXO), using common guidance method with an external display (ED) as a control condition
arm group label: parabolic flights
arm group type: Experimental
description: parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity (0g).
intervention type: Other
intervention name: 3 levels of gravity (1G, 1.8G, 0G).
description: healthy volunteers will experience 3 levels of gravity (1G, 1.8G, 0G).
arm group label: parabolic flights
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pierre Denise, MD-PhD
phone: +33 231.06.81.32
email: pierre.denise@unicaen.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: No