<?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>IRCT20180614040101N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-31</date_registration>
      <primary_sponsor>Kharazmi university</primary_sponsor>
      <public_title>Evaluating the effect of backpack carriage on schoolchildren’s gait in different gradients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of backpack carriage in different weights and gradients on kinetics and kinematics of schoolchildren’s gait</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>19</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32812</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Blinding description: Each participant is given a code, and all repetitions of measurement are run randomly, but the number is issued by the technician of the device, respectively. Therefore, the researcher and evaluator until the end of the analysis process in SPSS is unaware from the nature of the data and their relationship to the repetition.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Backpack, gait, kinetics, kinematics, slope, schoolchildren.</hc_freetext>
      <i_freetext>Intervention 1: Control group1: walking no load on level surface. Intervention 2: Control group2: walking while carrying a backpack with 10% of body weight load on the level surface. Intervention 3: Control group3: walking while carrying a backpack with 15% of body weight load on the level surface. Intervention 4: Intervention group1: walking while carrying a backpack with 10% of body weight load on 10% sloped surface. Intervention 5: Intervention group2:  walking while carrying a backpack with 15% of body weight load on 10% sloped surface. Intervention 6: Intervention group3:  walking while carrying a backpack with 10% of body weight load on 10% negative sloped surface. Intervention 7: Intervention group4: walking while carrying a backpack with 15% of body weight load on 10% negative sloped surface. Intervention 8: Intervention group5: walking while carrying a backpack with 10% of body weight load on 15% sloped surface. Intervention 9: Intervention group6: walking while carrying a backpack with 15% of body weight load on 15% sloped surface. Intervention 10: Intervention group7: walking while carrying a backpack with 10% of body weight load on 15% negative sloped surface. Intervention 11: Intervention group8: walking while carrying a backpack with 15% of body weight load on 15% negative sloped surface.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no need to publish IPD in this study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Ahmadi Godini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad, Hesari</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4398-15875</zip>
        <telephone>+98 22228001</telephone>
        <email>std_ahmadi.ths@khu.ac.ir</email>
        <affiliation>Kharazmi university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Khaleghi Tazeji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad, Hesari</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4398-15875</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>khaleghi@khu.ac.ir</email>
        <affiliation>Kharazmi university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>male gender (boys living in Tehran)
ages between 10-12 years
informed consent
right dominant hand and foot</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>12 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>current pain, disease and taking drug
any history of injuries for recent 6 month
any history of surgery
obvious postural abnormality, flat foot
vision and hearing impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group1: walking no load on level surface</i_keyword>
      <i_keyword>Control group2: walking while carrying a backpack with 10% of body weight load on the level surface.</i_keyword>
      <i_keyword>Control group3: walking while carrying a backpack with 15% of body weight load on the level surface.</i_keyword>
      <i_keyword>Intervention group1: walking while carrying a backpack with 10% of body weight load on 10% sloped surface.</i_keyword>
      <i_keyword>Intervention group2:  walking while carrying a backpack with 15% of body weight load on 10% sloped surface.</i_keyword>
      <i_keyword>Intervention group3:  walking while carrying a backpack with 10% of body weight load on 10% negative sloped surface.</i_keyword>
      <i_keyword>Intervention group4: walking while carrying a backpack with 15% of body weight load on 10% negative sloped surface.</i_keyword>
      <i_keyword>Intervention group5: walking while carrying a backpack with 10% of body weight load on 15% sloped surface.</i_keyword>
      <i_keyword>Intervention group6: walking while carrying a backpack with 15% of body weight load on 15% sloped surface</i_keyword>
      <i_keyword>Intervention group7: walking while carrying a backpack with 10% of body weight load on 15% negative sloped surface.</i_keyword>
      <i_keyword>Intervention group8: walking while carrying a backpack with 15% of body weight load on 15% negative sloped surface.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vertical ground reaction force. Timepoint: one time, while applying independent variable. Method of measurement: H/P/Cosmos Gaitway.</prim_outcome>
      <prim_outcome>Spatiotemporal parameters of gait. Timepoint: one time, while applying independent variable. Method of measurement: H/P/Cosmos Gaitway.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Kharazmi university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-21</approval_date>
        <contact_name>•Ethics committee of Tarbiat Modares University of Medical Sciences</contact_name>
        <contact_address>Jalal AleAhmad, Nasr, Tarbiat Modares University Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
