<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/NCT03814174</url>
  </required_header>
  <id_info>
    <org_study_id>17/751</org_study_id>
    <nct_id>NCT03814174</nct_id>
  </id_info>
  <brief_title>Comparison of Physical Fitness and Activities of the Children With Epilepsy and Their Healthy Peers</brief_title>
  <official_title>Comparison of Physical Fitness and Activities of the Children With Epilepsy and Their Healthy Peers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe 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>
      To investigate physical fitness and activity levels in children with epilepsy and compare the&#xD;
      results with healthy peers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many individuals with epilepsy are physically inactive due to the fear of seizures triggered&#xD;
      by physical activity/ exercise, and the advices given by the family members and the health&#xD;
      care professionals to avoid intense activity . In two studies performed about this subject,&#xD;
      this is the probable reason why adult patients with epilepsy have a weaker physical fitness&#xD;
      than healthy individuals in the control group. However; in a study of Drawskowski et al., the&#xD;
      avoidance of activity and exercise in individuals with epilepsy was investigated, and it was&#xD;
      reported that the injuries and seizure problems were rare even during very intense physical&#xD;
      activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 20, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>7 Days</target_duration>
  <primary_outcome>
    <measure>Number of steps on pedometer</measure>
    <time_frame>seven days</time_frame>
    <description>Participants will wear a pedometer (physical activity monitor) for seven consecutive days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exercise performance using 6-minute walk test</measure>
    <time_frame>1st day (before using device)</time_frame>
    <description>6-minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions. The distance walked by subjects during 6 minutes will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health-Related Physical Fitness Test for body compozition</measure>
    <time_frame>1st day (before using device)</time_frame>
    <description>body mass index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health-Related Physical Fitness Test for strenght</measure>
    <time_frame>1st day (before using device)</time_frame>
    <description>Cadance Based Curl-up Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health-Related Physical Fitness Test for balance</measure>
    <time_frame>1st day (before using device)</time_frame>
    <description>Flamingo Balance Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health-Related Physical Fitness Test for flexibility</measure>
    <time_frame>1st day (before using device)</time_frame>
    <description>Sit and Reach Test</description>
  </primary_outcome>
  <enrollment type="Actual">41</enrollment>
  <condition>Epilepsy</condition>
  <condition>Physical Activity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of children with epilepsy and their healthy peers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children who were diagnosed with epilepsy&#xD;
&#xD;
          -  children who can independently continue formal education,&#xD;
&#xD;
          -  children who do not need special education&#xD;
&#xD;
          -  children who have no additional neurological and neuromuscular disease (epilepsy only)&#xD;
&#xD;
          -  children who have a normal or higher cognitive level according to the WISC-R&#xD;
             intelligence test&#xD;
&#xD;
          -  children who were volunteers to participate in the study&#xD;
&#xD;
          -  children whose parents volunteers to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The disappearance of volunteerism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Gulsen SIRTBAS</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Childhood Epilepsy</keyword>
  <keyword>Physical Fitness</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Use of Pedometer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</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/NCT03814174
org study id: 17/751
nct id: NCT03814174
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate physical fitness and activity levels in children with epilepsy and compare the
      results with healthy peers.
Many individuals with epilepsy are physically inactive due to the fear of seizures triggered
      by physical activity/ exercise, and the advices given by the family members and the health
      care professionals to avoid intense activity . In two studies performed about this subject,
      this is the probable reason why adult patients with epilepsy have a weaker physical fitness
      than healthy individuals in the control group. However; in a study of Drawskowski et al., the
      avoidance of activity and exercise in individuals with epilepsy was investigated, and it was
      reported that the injuries and seizure problems were rare even during very intense physical
      activity.
observational model: Case-Control
time perspective: Prospective
measure: Number of steps on pedometer
time frame: seven days
description: Participants will wear a pedometer (physical activity monitor) for seven consecutive days.
measure: Exercise performance using 6-minute walk test
time frame: 1st day (before using device)
description: 6-minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions. The distance walked by subjects during 6 minutes will be recorded.
measure: Health-Related Physical Fitness Test for body compozition
time frame: 1st day (before using device)
description: body mass index
measure: Health-Related Physical Fitness Test for strenght
time frame: 1st day (before using device)
description: Cadance Based Curl-up Test
measure: Health-Related Physical Fitness Test for balance
time frame: 1st day (before using device)
description: Flamingo Balance Test
measure: Health-Related Physical Fitness Test for flexibility
time frame: 1st day (before using device)
description: Sit and Reach Test
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Gulsen SIRTBAS
investigator title: Principal Investigator
mesh term: Epilepsy