<?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>IRCT20250527065930N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-17</date_registration>
      <primary_sponsor>Bu Ali Sina University</primary_sponsor>
      <public_title>The effectiveness of exercise on flat feet</public_title>
      <acronym></acronym>
      <scientific_title>The effect of adding gluteus medius strengthening exercise into short foot exercise in children with excessive body weight with flexible flat foot</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84738</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done based on the Random Number Generator software and based on the allocation concealment using the SNOSE method, They will be assigned to two groups. We ask the software to randomly assign numbers 1 to 50 to two groups A and B. Group A is the combined group of gluteus medius and short foot strengthening exercises and group B is the short foot exercises group. We put numbers in sealed envelopes, the range of numbers is 1 to 50. The number of subjects is 50 and they will be divided into two groups of 25. Then we ask the participants to take the envelopes containing the numbers and the number that each participant chooses is divided according to the division that we have already done ourselves, which number is in which group, the person will enter the desired group and we perform this kind of randomization of the participants, Blinding description: In this study, outcome assessors, laboratory technicians, are asked to take the desired tests from the patients. These individuals will be unaware of the purpose of the study, the assignment of study groups, and the reason for their presence in the laboratory, and will only assess the variables and record their observations.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Flexible flat foot.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will combine gluteus medius strengthening exercises and short-foot exercises. The exercises will be for 8 weeks and 3 sessions per week for one hour. The equipment used will include a red elastic band with a difficulty level of 4 out of 5, a tennis ball, and a step towel. The exercises will last for one hour, including 10 minutes of warm-up, 40 minutes of specialized exercises for strengthening the gluteus medius and short-foot exercises, and 10 minutes of cool-down. The target muscles in this intervention include the gluteus medius muscle, the tibialis posterior muscle, the tibialis anterior muscle, the abductor hallux and peroneus longus muscles. Intervention 2: Control group: the short foot training control group will training for 8 weeks and 3 sessions per week for one hour.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mobina Roostaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu Ali Sina University, Abu Taleb St , Modares Quarter</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3838 1423</telephone>
        <email>m.roostaei@phe.basu.ac.ir</email>
        <affiliation>Bu Ali Sina University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mobina Roostaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bu Ali Sina University, Abu Taleb St, Modares Quarter</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3838 1423</telephone>
        <email>m.roostaei@phe.basu.ac.ir</email>
        <affiliation>Bu Ali Sina University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Navicular bone loss index greater than 10 mm
Body mass index greater than 19 Kg/m2
Girls between 10 and 13 years old
No history of lower limb injury or surgery
Not using orthopedic insoles in the past six months
Has a flat, flexible foot
Puberty has occurred</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>13 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use of orthopedic insoles
Having neuromuscular problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M21.40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Flat foot [pes planus] (acquired), unspecified foot</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will combine gluteus medius strengthening exercises and short-foot exercises. The exercises will be for 8 weeks and 3 sessions per week for one hour. The equipment used will include a red elastic band with a difficulty level of 4 out of 5, a tennis ball, and a step towel. The exercises will last for one hour, including 10 minutes of warm-up, 40 minutes of specialized exercises for strengthening the gluteus medius and short-foot exercises, and 10 minutes of cool-down. The target muscles in this intervention include the gluteus medius muscle, the tibialis posterior muscle, the tibialis anterior muscle, the abductor hallux and peroneus longus muscles.</i_keyword>
      <i_keyword>Control group: the short foot training control group will training for 8 weeks and 3 sessions per week for one hour.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Navicular drop greater than 10 mm. Timepoint: Before the intervention begins, one day after the intervention ends. Method of measurement: Stretcher.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance. Timepoint: Before the intervention begins, one day after the intervention ends. Method of measurement: Dynamic balance test (Y).</sec_outcome>
      <sec_outcome>Proprioceptive. Timepoint: Before the intervention begins, one day after the intervention ends. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Plantar pressure variables. Timepoint: Before the intervention begins, one day after the intervention ends. Method of measurement: Foot scan device.</sec_outcome>
      <sec_outcome>Pain. Timepoint: Before the intervention begins, one day after the intervention ends. Method of measurement: VAS pain questionnaire.</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>Bu Ali Sina University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-02</approval_date>
        <contact_name>Ethics committee of Bu Ali Sina University</contact_name>
        <contact_address>Bu Ali Sina University, Abu Taleb St, Modares Quarter Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
