<?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>IRCT20200204046368N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-24</date_registration>
      <primary_sponsor>Arak university</primary_sponsor>
      <public_title>The effect of taping on pes planus</public_title>
      <acronym></acronym>
      <scientific_title>The effects of kinesio tape and dynamic tape on postural sway, balance, and range of motion of the ankle joint following fatigue in people with pes planus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69334</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: In this study, 3 interventions of kinesio tape, dynamic tape, and control are investigated and compared in a group of people with pes planus on three separate days. Each intervention is done in a separate session. The intervention that is done for each session is determined at the beginning of the session through a lottery. Then, in the next session, a draw will be made between the remaining two interventions, Blinding description: The data analyzer will not be aware of the group's classification. The information of the groups will be provided to the data analyzer in the form of numbers 1, 2, and 3, and for each participant with a code.</study_design>
      <phase>N/A</phase>
      <hc_freetext>flat foot.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: In the first intervention, the kinesio tape (Ares brand, made in South Korea) is applied to the foot by the low-dye taping method. After 20-30 minutes evaluations are done. After completing the evaluations, the fatigue protocol is performed, and after fatigue, the evaluations are repeated. The tape is removed from the foot and the next intervention is performed 2 to 4 days later. Intervention 2: Intervention group 2: In the second intervention group, the dynamic tape (made in the USA) is applied to the foot with the low dye taping method. After 45 minutes, evaluations are done. After completing the evaluations, the fatigue protocol is performed, and after fatigue, the evaluations are repeated. The tape is removed from the foot and the next intervention is performed 2 to 4 days later. Intervention 3: Control group: In the control group without tape, evaluations are done before and after fatigue.</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 information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Raeisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University, Karbala Boulevard, Basij Square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848177584</zip>
        <telephone>+98 86 3417 3492</telephone>
        <email>Z_raisi13@yahoo.com</email>
        <affiliation>Arak University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Raeisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University, Karbala Boulevard, Basij Square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848177584</zip>
        <telephone>+98 86 3417 3492</telephone>
        <email>Z_raisi13@yahoo.com</email>
        <affiliation>Arak University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A navicular drop of more than 10 mm
No history of lower limb injury in the last 6 months
Age between 18 and 30 years
Not taking any drugs affecting the nervous system and postural control</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a history of lower limb surgery</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: In the first intervention, the kinesio tape (Ares brand, made in South Korea) is applied to the foot by the low-dye taping method. After 20-30 minutes evaluations are done. After completing the evaluations, the fatigue protocol is performed, and after fatigue, the evaluations are repeated. The tape is removed from the foot and the next intervention is performed 2 to 4 days later.</i_keyword>
      <i_keyword>Intervention group 2: In the second intervention group, the dynamic tape (made in the USA) is applied to the foot with the low dye taping method. After 45 minutes, evaluations are done. After completing the evaluations, the fatigue protocol is performed, and after fatigue, the evaluations are repeated. The tape is removed from the foot and the next intervention is performed 2 to 4 days later.</i_keyword>
      <i_keyword>Control group: In the control group without tape, evaluations are done before and after fatigue.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Navicular drop. Timepoint: Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions. Method of measurement: The Brody's evaluation method.</prim_outcome>
      <prim_outcome>Foot posture index. Timepoint: Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions. Method of measurement: The foot posture index (FPI-6).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Joint position sense. Timepoint: Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Gait. Timepoint: Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions. Method of measurement: Pedoscan.</sec_outcome>
      <sec_outcome>Balance. Timepoint: Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions. Method of measurement: Y balance test.</sec_outcome>
      <sec_outcome>Joint range of motion with and without weight bearing. Timepoint: Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions. Method of measurement: Goniometer , Weight-bearing lunge test.</sec_outcome>
      <sec_outcome>Medial Longitudinal Arch Angle (MLAA). Timepoint: Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions. Method of measurement: Photogrammetry.</sec_outcome>
      <sec_outcome>Longitudinal arch angle. Timepoint: Before and after fatigue for each of the three control, dynamic tape and kinesio tape conditions. Method of measurement: Photogrammetry.</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>Arak university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-19</approval_date>
        <contact_name>Research Ethics Committee of Arak University</contact_name>
        <contact_address>Arak University, Karbala Boulevard, Basij Square Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
