<?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>IRCT20201128049511N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-14</date_registration>
      <primary_sponsor>University of Tarbiat Modares</primary_sponsor>
      <public_title>The Effect of Exercise Therapy on the Human Body Performance in Women with Flat Feet</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of 6 Weeks Combined Training of the Intrinsic Foot Muscles and Tibialis Posterior on the Biomechanical Performance of Jumping in Women with Flexible Flat Feet</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71119</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Randomization in this study will be done by block randomization method. Participants will be randomly assigned into intervention or control groups. The number of blocks will be 4, 6, and 8. Also, the blocks will be randomly sealed in the envelope. For random assignment, code 1 for the intervention group and code 0 for the control group are placed in the envelopes. subjects will choose an envelope and then, based on the chosen code, they are assigned in one of the groups, Blinding description: The Person Recording the Lab's Data and the Person Analyzing the Data are not aware of the study group allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Flexible Flat Feet.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention consists of 6 weeks of exercises for women with flexible flat feet. In the first session, after measuring the height of the medial arch of the foot and getting familiar with how to perform the tests, the subject will perform the jump tests and then, the variables will be recorded. Then the person will be taught to do both short foot exercises and foot adduction exercises with an elastic band. The individuals should do these exercises for 6 weeks, with a frequency of 5 times a week and 3 sets of 10 each time. After the end of 6 weeks, the final evaluation session will be done in the laboratory like the first session. Intervention 2: Control group: This group will not receive any exercise and participants will be evaluated before and after 6 weeks. In the first session, after measuring the height of the medial arch of the foot and getting familiar with how to perform the tests, the subject will perform the jump tests and then, the variables will be recorded. After the end of 6 weeks, the final evaluation session will be done in the laboratory like the first session.</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:
Information about the main outcome can be shared after people are not identified.

When:
After the results are published, the access phase started six months later

To whom:
Researchers in academic and research organizations will also have access to the data.

Conditions:
To do scientific research

Where to obtain:
to do scientific research, Sahar Boozari, Jalal Al Ahmad Highway, Tarbiat Modares University, s.boozari@modares.ac.ir, 00982182885053

How to obtain:
Send the project plan, and if approved, it will be sent following a complete evaluation of the persons and organizations involved in the project.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sargol abolhasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 5053</telephone>
        <email>Sargol.abolhasaniii@gmail.com</email>
        <affiliation>The University of Tarbiat Modares</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sahar Boozari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Tehran, Jalal Al ahmad Highway, Nasr Bridge, Tarbiat Modares University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 5053</telephone>
        <email>s.boozari@modares.ac.ir</email>
        <affiliation>The University of Tarbiat Modares</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-athlete Women Suffering from Bilateral Flexible Flat Feet (Arch Height Ratio less than 0.221)
Age 18-45 years old
Normal Body Mass Index (18.5-25)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of any lasting orthopedic or neurological injury in the lower limbs and spine
The difference in the actual length of the lower body be more than 1.5 centimeters
Significant congenital malformations in the lower limbs
Body mass index more than 25
Obvious deformities such as hallux valgus, genu varus, genu valgum and internal rotation of the thigh</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M21.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Flat foot [pes planus] (acquired)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention consists of 6 weeks of exercises for women with flexible flat feet. In the first session, after measuring the height of the medial arch of the foot and getting familiar with how to perform the tests, the subject will perform the jump tests and then, the variables will be recorded. Then the person will be taught to do both short foot exercises and foot adduction exercises with an elastic band. The individuals should do these exercises for 6 weeks, with a frequency of 5 times a week and 3 sets of 10 each time. After the end of 6 weeks, the final evaluation session will be done in the laboratory like the first session.</i_keyword>
      <i_keyword>Control group: This group will not receive any exercise and participants will be evaluated before and after 6 weeks. In the first session, after measuring the height of the medial arch of the foot and getting familiar with how to perform the tests, the subject will perform the jump tests and then, the variables will be recorded. After the end of 6 weeks, the final evaluation session will be done in the laboratory like the first session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Biomechanical variables related to jump. Timepoint: Before and after 6 weeks after intervention. Method of measurement: Force plate device.</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>University of Tarbiat Modares</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-29</approval_date>
        <contact_name>Ethics committee of Tarbiat Modares University</contact_name>
        <contact_address>Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
