<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/NCT03812822</url>
  </required_header>
  <id_info>
    <org_study_id>2018/376</org_study_id>
    <nct_id>NCT03812822</nct_id>
  </id_info>
  <brief_title>Describing the Effects of Insoles in Children With Increased Femoral Anteversion and Pes Planovalgus</brief_title>
  <official_title>The Effects of Using Insoles on Walking in Children With Increased Femoral Anteversion and Pes Planovalgus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Kültür University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Kültür University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Increased Femoral Anteversion is a transverse plan problem that affects lower body alignment,&#xD;
      walking and standing characteristics and also pes planovalgus mostly accompanies with IFA. It&#xD;
      is shown that children with IFA and PPV have back and leg pain, fatigue, muscle cramps and&#xD;
      they are under the risk for chronic disorders such as osteoarthritis, scoliosis and muscle&#xD;
      injuries.&#xD;
&#xD;
      Insoles, which reduce pronation of foot (flat foot), provide apparently a static correction&#xD;
      by supporting proper alignment in children with IFA and PPV. However, the dynamic effects of&#xD;
      insoles to lower extremity biomechanics while walking is not known.&#xD;
&#xD;
      The aims of this study are to determine the effects of the insoles on walking biomechanics in&#xD;
      children with IFA and PPV by comparing with their healthy peers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 24, 2019</completion_date>
  <primary_completion_date type="Actual">December 24, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gait Analysis</measure>
    <time_frame>Day 1</time_frame>
    <description>Three-dimensional gait analysis (Temporo-spatial parameters and pelvis, hip, knee and ankle kinematic in three plans)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Static Foot Posture Assesment</measure>
    <time_frame>Day 1</time_frame>
    <description>Foot Posture Index - 6 6 items ( 1.talar head palpation, 2.supra and infra lateral malleolar curvature,3.calcaneal frontal plane position, 4.prominence in the region of the talonavicular joint, 5.congruence of the medial longitudinal arch, and 6.abduction/adduction of the forefoot on the rearfoot)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Femoral Anteversion</condition>
  <condition>Pes Planovalgus</condition>
  <condition>Flat Foot</condition>
  <arm_group>
    <arm_group_label>Insole Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gait and foot posture analysis with and without the insole.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Gait and foot posture analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insole</intervention_name>
    <description>Custom-made insoles which support the foot at subtalar neutral position</description>
    <arm_group_label>Insole Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Insole Group Between the ages 7-15, Trochanteric Prominens Angle Test &gt; 20⁰, Hip&#xD;
             internal rotation angle &gt; 60⁰, Without insole Foot Posture Index score &gt; 5, With&#xD;
             insole Foot Posture Index score &gt; 4, Using their insoles' at least one month.&#xD;
&#xD;
          -  Control Group Between the ages 7-15, Trochanteric Prominens Angle Test &lt; 20⁰, Foot&#xD;
             Posture Index score &lt; 5, Without any neurologic or orthopedic disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Neurological and / or musculoskeletal problems, Orthopedic problems to prevent walking.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Halenur Evrendilek, GRAD ASST</last_name>
    <role>Study Chair</role>
    <affiliation>İstanbul Kültür University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ekin Akalan, PROF</last_name>
    <role>Study Director</role>
    <affiliation>İstanbul Kültür University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Miray Budak, ASST PROF</last_name>
    <role>Study Director</role>
    <affiliation>İstanbul Medipol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>İstanbul Kültür Üniversitesi</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>İstanbul University, Faculty of Medicine</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>March 12, 2020</last_update_submitted>
  <last_update_submitted_qc>March 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Kültür University</investigator_affiliation>
    <investigator_full_name>Halenur Evrendilek</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Femoral anteversion, flat foot, insole, gait</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flatfoot</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03812822
org study id: 2018/376
nct id: NCT03812822
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Increased Femoral Anteversion is a transverse plan problem that affects lower body alignment,
      walking and standing characteristics and also pes planovalgus mostly accompanies with IFA. It
      is shown that children with IFA and PPV have back and leg pain, fatigue, muscle cramps and
      they are under the risk for chronic disorders such as osteoarthritis, scoliosis and muscle
      injuries.

      Insoles, which reduce pronation of foot (flat foot), provide apparently a static correction
      by supporting proper alignment in children with IFA and PPV. However, the dynamic effects of
      insoles to lower extremity biomechanics while walking is not known.

      The aims of this study are to determine the effects of the insoles on walking biomechanics in
      children with IFA and PPV by comparing with their healthy peers.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Gait Analysis
time frame: Day 1
description: Three-dimensional gait analysis (Temporo-spatial parameters and pelvis, hip, knee and ankle kinematic in three plans)
measure: Static Foot Posture Assesment
time frame: Day 1
description: Foot Posture Index - 6 6 items ( 1.talar head palpation, 2.supra and infra lateral malleolar curvature,3.calcaneal frontal plane position, 4.prominence in the region of the talonavicular joint, 5.congruence of the medial longitudinal arch, and 6.abduction/adduction of the forefoot on the rearfoot)
arm group label: Insole Group
arm group type: Experimental
description: Gait and foot posture analysis with and without the insole.
arm group label: Control Group
arm group type: No Intervention
description: Gait and foot posture analysis.
intervention type: Device
intervention name: Insole
description: Custom-made insoles which support the foot at subtalar neutral position
arm group label: Insole Group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Halenur Evrendilek, GRAD ASST
role: Study Chair
affiliation: İstanbul Kültür University
last name: Ekin Akalan, PROF
role: Study Director
affiliation: İstanbul Kültür University
last name: Miray Budak, ASST PROF
role: Study Director
affiliation: İstanbul Medipol University
facility: 
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Kültür University
investigator full name: Halenur Evrendilek
investigator title: Research Assistant
mesh term: Flatfoot
sharing ipd: Undecided