<?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>IRCT20210818052223N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-08</date_registration>
      <primary_sponsor>The University Of Tehran</primary_sponsor>
      <public_title>Comparison the activation sequences of deep and superficial foot muscle on CSA and navicular drop in flat feet children</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of activation sequences of intrinsic and extrinsic foot muscles on selected foot muscles cross section area and Normalized Truncated Navicular  Height  in boys afflicted by  flat foot</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>8</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58239</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: After recruiting the participants in the research, their names are chronologically written in a list. After that, each participant is allocated a number. Two groups of intrinsic and extrinsic exercises are assigned to the participants based on a random table of numbers. In this way, a number is randomly selected first, and then by the movement to one direction, the next numbers are selected until half of the participants are selected for the intrinsic group, Blinding description: In this study, the evaluator ( rehabilitation specialist) will not know whom she is analysing. For blind the evaluator, the groups and their exercises will remain unknown. Also the data analyst will not have access to this information. For this, the information related to the groups would be given the data analyst in a way that will not reveal the group members.</study_design>
      <phase>N/A</phase>
      <hc_freetext>flexible flat foot.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: intrinsic foot muscle strengthening. the participants will recieved short foot exercises at minimum three days a week, one hour during the day in six weeks. they need only a theraband. Intervention 2: Intervention group: extrinsic foot muscels strengthening. the exercises will include strengthening of gastrocinemius, soleus and tibilais anterior and posterior muscles.  the participants will performe exercises at minimum three days a week, one hour during the day in six weeks. they need only a theraband.</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:
the private information of the patricipants will not published, but the assessment information will.

When:
will be accessible from 2021

To whom:
the data will be accessible as paper and phd thesis for interested individuals.

Conditions:
the interested individuals that approximate the university to access the thesis or individuals that have access to the publisher.

Where to obtain:
university of tehran, sport science faculty.

How to obtain:
after showing student card, the student can have access to thesis.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jafar Ketabchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 37, Gole Roz Ave, Barazande Ave, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8193843155</zip>
        <telephone>+98 31 3458 3685</telephone>
        <email>J.ketabchi@ut.ac.ir</email>
        <affiliation>The University Of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jafar Ketabchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 37, Gole Roz Ave, Barazande Ave, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8193843155</zip>
        <telephone>+98 31 3458 3685</telephone>
        <email>J.ketabchi@ut.ac.ir</email>
        <affiliation>The University Of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>flexible flat foot
haven't structural deformity in pelvic or foot
don't use insole support during the study period
10-13 age 
boys
don't use medicine or have a special surgery</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>13 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Structural flat foot
Have a structural deformity in the pelvic or foot
No willingness  to enter the study
use other modalities during the study</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: intrinsic foot muscle strengthening. the participants will recieved short foot exercises at minimum three days a week, one hour during the day in six weeks. they need only a theraband.</i_keyword>
      <i_keyword>Intervention group: extrinsic foot muscels strengthening. the exercises will include strengthening of gastrocinemius, soleus and tibilais anterior and posterior muscles.  the participants will performe exercises at minimum three days a week, one hour during the day in six weeks. they need only a theraband.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cross section area of selective foot muscels. Timepoint: before, 6 weeks after and 12 weeks after. Method of measurement: ultrasond alpinon ecube 9.</prim_outcome>
      <prim_outcome>Navicular drop. Timepoint: before, 6 weeks and 12 weeks after. Method of measurement: ruller.</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>The University Of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-20</approval_date>
        <contact_name>Ethics Committee of Tehran University</contact_name>
        <contact_address>16th Azar St., Enghelab Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
