<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2014030916914N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-15</date_registration>
      <primary_sponsor>Vice Chancellor for research of Research in Baqiatallah Medical University, Trauma Research Center</primary_sponsor>
      <public_title>Effect of Foot Arc Support in prevention of Foot Pain and Tenderness,ankle strain and sprain</public_title>
      <acronym></acronym>
      <scientific_title>Investigation on correlation between use of foot arc support and, Foot Pain and Tenderness, ankle strain and sprain in the population of soldiers in Shahid Hasheminejad garrisongarrison</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>580</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15692</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Stress Fracture. Condition 2: Ankle Sprain and Strain.</hc_freetext>
      <i_freetext>Intervention 1: Soldiers who meet the inclusion criteria are divided into two groups according to random numbers table, foot arc support which is made of polyurethane is allocated to one group and nothing will be given to the other group. Foot arc support is believed to help to deliver the force along a bigger area of the foot sole and therefore reduce the pressure.The soldiers will be followed for stress fracture, sprain and strain and different foot parts pain and tenderness occurrence. Intervention 2: An ordinary martial boot will be given to the control group.They will experience same martial exercises as the intervention group. They will also be followed for occurrence of different foot part pain and tenderness and ankle strain and sprain during the 2-months period of their military service.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saman Naazemyaan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address># 52-54, Qod 3rd st, Malek Abad Ave.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9185764733</zip>
        <telephone>+98 51 1800 2141</telephone>
        <email>Nazemians861@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences, Faculty of Medicine</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Hesarikia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiatallah Hospital, Sheikhbahaee St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8805 3769</telephone>
        <email>pajuhesh_trauma@yahoo.com</email>
        <affiliation>Baqiatallah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
The arc of the foot must not be less than normal ( the arc height should be at least about 1.5 cm);&#13;
The difference between the actual size of the the lowers limbs must not be more than 1 cm;&#13;
No history of fracture in the lower limbs must be present;&#13;
Must not be a professional athlete in football, volleyball, basketball or judo, taekwondo or other martial sports;&#13;
Body Mass Index ( BMI ) must not be less than 20;&#13;
Must not be exempted from marching by physician's order;&#13;
&#13;
Exclusion criteria&#13;
If for any reason the soldier does not use the support or it goes wrecked;&#13;
If the soldier is discharged from the military service for any reason;</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M84.3</hc_code>
      <hc_code>S93.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress fracture, not elsewhere classified Stress fracture NOS</hc_keyword>
      <hc_keyword>Calcaneofibular (ligament) Deltoid (ligament) Internal collateral (ligament) Talofibular (ligament) Tibiofibular (ligament), distal</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Soldiers who meet the inclusion criteria are divided into two groups according to random numbers table, foot arc support which is made of polyurethane is allocated to one group and nothing will be given to the other group. Foot arc support is believed to help to deliver the force along a bigger area of the foot sole and therefore reduce the pressure.The soldiers will be followed for stress fracture, sprain and strain and different foot parts pain and tenderness occurrence.</i_keyword>
      <i_keyword>An ordinary martial boot will be given to the control group.They will experience same martial exercises as the intervention group. They will also be followed for occurrence of different foot part pain and tenderness and ankle strain and sprain during the 2-months period of their military service.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress Fracture. Timepoint: During the 2 months period of military service. Method of measurement: stress fracture symptoms are introduced to the soldiers and when they feel pain in their foot they will come to the clinic and an X-ray of the foot will be ordered, if there was a fracture, the diagnosis is definite.</prim_outcome>
      <prim_outcome>Ankle strain and sprain. Timepoint: During the 2 months period of military service. Method of measurement: Ankle sprain and strain symptoms are introduced to the soldiers, if it happens they come to the clinic and they will be examined for swelling or echymosis in the following days.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Tenderness in different parts of the foot. Timepoint: At the beginning and the end of the 2 months period of military service. Method of measurement: By touching firmly on tibia shin, ankle, calcaneum and metatarses the physician asks about feeling pain.</sec_outcome>
      <sec_outcome>Pain in different parts of the foot. Timepoint: At the beginning and the end of the 2 months period of military service. Method of measurement: Without touching on tibia shin, ankle, calcaneum and metatarses the physician asks about feeling pain and measuring pain severity according to VAS method by showing its pictures to the soldiers.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor for research of Research in Baqiatallah Medical University, Trauma Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-10-27</approval_date>
        <contact_name>Ethics in Research Committee, Baqiatallah University of Medical Sciences</contact_name>
        <contact_address>Baqiatallah University, Sheikh bahaee St. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
