<?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>IRCT20240126060810N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-06</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of Intrinsic foot muscle strengthening on flexible flat feet</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Intrinsic foot muscle(IFM) exercises on static and dynamic balance , Ankle dorsi flexion Range Of Motion(ROM) &amp; performance of adolescent soccer players with flexible flat feet</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75384</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The first physiotherapy assistant will divide people into intervention and control group using sealed envelope method. 44 envelopes(22 being number 1 and 22 being number 2) with numbers 1 &amp; 2(one of them being intervention and the other being control group) are used which only the second physiotherapist(the main therapist) knows.Before being chosen by the patients , the order of the envelopes will be changed numerously and after they have chosen the envelope , its number will be recorded.
The background information form is completed by the participant after randomization with the help of the first physiotherapist, Blinding description: In this study the person(Physiotherapist assistant) which randomizes participants and does the testings is blind. The way to conduct the tests and randomization process will be taught to assistant without telling them about the way to interpretate them. They just write the numbers.
Participants will also be blind by the way of concealed envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Flexible Flat Foot.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: IFM exercises for 6 weeks                                           The first week :Towel curl exercise (in this exercise, the person sits and the knee is bent at 90 degrees, bends slightly forward and puts the weight of the hand on the knee to load the ankle joint. Then, without lifting the heel, the first and fifth metatarsals tries to curl towels)                            The second week : The Big toe extension exercise (in this exercise, the person sits and the knee is bent at 90 degrees, bends slightly forward and puts the weight of the hand on the knee to load the ankle joint. Then, without lifting the heel, the first metatarsal and the fifth metatarsal tries to lift the big toe while the rest of the toes are on the ground and not bent)    The third week : The second to fifth metatarsal extension exercise (in this exercise, the person sits and the knee is bent at 90 degrees, bends slightly forward and puts the weight of the hand on the knee to load the ankle joint. Then, without lifting the heel, The first metatarsal and the fifth metatarsal tries to lift the second to fifth toes, while the big toe rests on the ground and does not bend.                                                                         The fourth week : Toe Spread Out exercise (in this exercise, the person sits and the knee is bent at 90 degrees, bends slightly forward and puts the weight of the hand on the knee to load the ankle joint. Then, without lifting the heel, the first metatarsal And the fifth metatarsal tries to lift all the toes together and first places the big toe, then the fifth toe, and then the fourth, third and second toes respectively, while an abductor component is applied to the toes.(tries to open fingers)                                The fifth week : Short Foot exercise (in this exercise, the person sits and the knee is bent at 90 degrees, bends slightly forward and puts the weight of the hand on the knee to load the ankle joint. Then, without lifting the heel, the first metatarsal and The fifth metatarsal tries to bring the first and fifth metatarsals closer to the heel and increases the arch of the foot.  The sixth week : Vele's Forward lean exercise (in this exercise, the person stands and tries to push himself forward without lifting the heel as far as he can with straight knees and hands by the side of the body. After completing this exercise, tries to walk backwards in Tandem position). Intervention 2: Control group: Non bio mechanic function of ankle exercises for 6 weeks    These exercises include plantar and dorsiflexion of the metatarsophalangeal joint in the Unloaded position (sitting) with the knee bent at 90 degrees. The control group performs these exercises for 6 weeks. The control group will do these exercises 5 times a day, hold the movement for 30 seconds each time and rest for 10 seconds and do 10 repetitions and then do the next exercise. In order to comply with ethical principles, the control group will benefit from the exercises of the intervention group after the completion of the research project.</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 further detail</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Poorya Rouhidel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5 , 1st  Golestan Street , Shahrak Shid Mahallati Town , Mini city District</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955754691</zip>
        <telephone>+98 21 2246 4265</telephone>
        <email>pooryarouhidel@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Poorya Rouhidel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5 , 1st Golestan Street , Shahid Mahallati Town , Mini city District</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955754691</zip>
        <telephone>+98 21 2246 4265</telephone>
        <email>pooryarouhidel@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adolescent football players from different football clubs that are professional according to Early sport specialization
10-19 years of age
More than +6 FPI(Foot Posture Index)</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>19 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>No acute injury , fracture or surgery of the lower extremity in the past 3 months
No history of foot or lower leg pathology and gait disturbances in the past 6 months
No neurological or vestibular disease</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: IFM exercises for 6 weeks                                           The first week :Towel curl exercise (in this exercise, the person sits and the knee is bent at 90 degrees, bends slightly forward and puts the weight of the hand on the knee to load the ankle joint. Then, without lifting the heel, the first and fifth metatarsals tries to curl towels)                            The second week : The Big toe extension exercise (in this exercise, the person sits and the knee is bent at 90 degrees, bends slightly forward and puts the weight of the hand on the knee to load the ankle joint. Then, without lifting the heel, the first metatarsal and the fifth metatarsal tries to lift the big toe while the rest of the toes are on the ground and not bent)    The third week : The second to fifth metatarsal extension exercise (in this exercise, the person sits and the knee is bent at 90 degrees, bends slightly forward and puts the weight of the hand on the knee to load the ankle joint. Then, without lifting the heel, The first metatarsal and the fifth metatarsal tries to lift the second to fifth toes, while the big toe rests on the ground and does not bend.                                                                         The fourth week : Toe Spread Out exercise (in this exercise, the person sits and the knee is bent at 90 degrees, bends slightly forward and puts the weight of the hand on the knee to load the ankle joint. Then, without lifting the heel, the first metatarsal And the fifth metatarsal tries to lift all the toes together and first places the big toe, then the fifth toe, and then the fourth, third and second toes respectively, while an abductor component is applied to the toes.(tries to open fingers)                                The fifth week : Short Foot exercise (in this exercise, the person sits and the knee is bent at 90 degrees, bends slightly forward and puts the weight of the hand on the knee to load the ankle joint. Then, without lifting the heel, the first metatarsal and The fifth metatarsal tries to bring the first and fifth metatarsals closer to the heel and increases the arch of the foot.  The sixth week : Vele's Forward lean exercise (in this exercise, the person stands and tries to push himself forward without lifting the heel as far as he can with straight knees and hands by the side of the body. After completing this exercise, tries to walk backwards in Tandem position)</i_keyword>
      <i_keyword>Control group: Non bio mechanic function of ankle exercises for 6 weeks    These exercises include plantar and dorsiflexion of the metatarsophalangeal joint in the Unloaded position (sitting) with the knee bent at 90 degrees. The control group performs these exercises for 6 weeks. The control group will do these exercises 5 times a day, hold the movement for 30 seconds each time and rest for 10 seconds and do 10 repetitions and then do the next exercise. In order to comply with ethical principles, the control group will benefit from the exercises of the intervention group after the completion of the research project.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reaching distance in modified star balance test in three directions anterior, posterior medial and posterior lateral. Timepoint: Before intervention , 3rd week , 6th week. Method of measurement: Tape measure.</prim_outcome>
      <prim_outcome>Number of errors in the balance error scoring system. Timepoint: Before intervention , 3rd week , 6th week. Method of measurement: Balance Error Scoring System.</prim_outcome>
      <prim_outcome>Lateral hop test score. Timepoint: Before intervention , 3rd week , 6th week. Method of measurement: Digital watch.</prim_outcome>
      <prim_outcome>Ankle dorsiflexion range of motion. Timepoint: Before intervention , 3rd week , 6th week. Method of measurement: Goniometer.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>1998-07-14</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No. 5 , first Golestan street , Shahid Mahallati town , Minicity district Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
