<?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>IRCT20130109012078N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-14</date_registration>
      <primary_sponsor>kharazmi University</primary_sponsor>
      <public_title>Investigating the effect of pedagogy on gait pattern</public_title>
      <acronym></acronym>
      <scientific_title>The effect of different types of pedagogy (linear and nonlinear) on lower limb kinematics in walking motor skills in children: a preliminary study of injury prevention</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55321</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: By lottery, individuals are divided into intervention and control groups. The children's names are written on a piece of paper and placed in a box. The names are then randomly removed from the box. Then the first person in the linear group, the second person in the nonlinear group and the third person in the control group are placed and continue, respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>gait.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: linear pedagogy. In linear pedagogy, the child will first be presented with the correct gait pattern (verbally and with a visual pattern). The child will then be asked to follow the specified path and at the same time the child will be given feedback. - Training period: six weeks, - Number of training sessions per week: two sessions per week, - Duration of each training session: 30 minutes (5 minutes of warm-up, 20 minutes of the main body of the class which includes walking training, 5 minutes of cool-down will be performed in each session). Intervention 2: Intervention group 2: nonlinear pedagogy. In non-linear, each session will be designed according to the intended goals. The child will then be allowed to walk in the environment. - Training period: six weeks, - Number of training sessions per week: two sessions per week, - Duration of each training session: 30 minutes (5 minutes of warm-up, 20 minutes of the main body of the class which includes walking training, 5 minutes of cool-down will be performed in each session). Intervention 3: Control group: control. The control group will not receive training for six weeks. They will only take the pre-test and post-test.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data on walking kinematics, stride length, and static balance before and after the intervention will provided to the audience.

When:
September 2021

To whom:
Students and university professors

Conditions:
This trial will be published in the form of a master's thesis.

Where to obtain:
One should refer to the library of Kharazmi University.

How to obtain:
Students will go to the library and receive a thesis file from the librarian.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>maryam ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 27., Deilman Str, Nofalah Str, Azadi St., Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1313886873</zip>
        <telephone>+98 21 6656 2382</telephone>
        <email>maryamm_ghorbanii@yahoo.com</email>
        <affiliation>kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rasoul Yaali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education &amp; Sports Sciences Kharazmi University of Tehran, Mirdamad Ave, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1571914911</zip>
        <telephone>+98 21 8832 9220</telephone>
        <email>r.yaali@khu.ac.ir</email>
        <affiliation>kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>children aged 3-5 years.
without a history of injury and underlying disease.
Ability to walk.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>5 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children with physical and mental disorders.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y93.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Activities involving walking and running</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: linear pedagogy. In linear pedagogy, the child will first be presented with the correct gait pattern (verbally and with a visual pattern). The child will then be asked to follow the specified path and at the same time the child will be given feedback. - Training period: six weeks, - Number of training sessions per week: two sessions per week, - Duration of each training session: 30 minutes (5 minutes of warm-up, 20 minutes of the main body of the class which includes walking training, 5 minutes of cool-down will be performed in each session).</i_keyword>
      <i_keyword>Intervention group 2: nonlinear pedagogy. In non-linear, each session will be designed according to the intended goals. The child will then be allowed to walk in the environment. - Training period: six weeks, - Number of training sessions per week: two sessions per week, - Duration of each training session: 30 minutes (5 minutes of warm-up, 20 minutes of the main body of the class which includes walking training, 5 minutes of cool-down will be performed in each session).</i_keyword>
      <i_keyword>Control group: control. The control group will not receive training for six weeks. They will only take the pre-test and post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Kinematics of gait (angles of the lower extremity joints) in the sagittal plane. Timepoint: Measurements will be performed before and after the training intervention. Method of measurement: Using GoPro Black 7 camera, children's gait will be recorded before and after the intervention. Using Kinovea software, the measurements of the joint angles of the lower extremity at the moment of heel contact with the ground and the moment of the big toe off from the ground will be calculated.</prim_outcome>
      <prim_outcome>Stride length. Timepoint: Measurements will be performed before and after the training intervention. Method of measurement: Using GoPro Black 7 camera, children's gait will be recorded before and after the intervention. Stride length will be calculated by using Kinovea software.</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>2020-12-06</approval_date>
        <contact_name>Kharazmi University</contact_name>
        <contact_address>Faculty of Physical Education &amp; Sports Sciences of Kharazmi University, Mirdamad Ave, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
