<?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>IRCT20201128049511N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-28</date_registration>
      <primary_sponsor>University of Tarbiat Modares</primary_sponsor>
      <public_title>Effect of Elastic Bands on the Human Body Performance in Women with Flatfeet</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Kinesiotape on the Performance of the Musculoskeletal System in Women with Flexible Flatfeet in Conditions with and without Fatigue</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65262</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization in this study will be done by the block randomization method. In the first session, people are randomly assigned to either kinesiotape or sham tape groups. The number of blocks will be 4 and 6, and randomly be placed in sealed envelopes. For the random assignment, code 1 for the kinesiotape group and code 0 for the sham tape group are placed in the envelopes. subjects will choose a closed envelope and are placed in the kinesiotape or sham tape group based on the selected code, Blinding description: In the kinesiotape group, the Kinesiotape, which is an elastic therapeutic tape, is attached to the posterior tibialis muscle, the transverse arch, and the inner longitudinal arch of the foot with a special tension to correct the arch and improve muscle function. For the sham group, a piece of tape is attached to the inside of the ankle, that is, in a place other than the treatment area and without tension. Study participants are not aware of whether they are in the kinesiotape or sham group and are not familiar with the treatment. The engineer responsible for data recording also does not have information about how to stick the Kinesiotape, which is a therapeutic task and is blinded to the people in the two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Flexible flatfoot.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: intervention includes kinesiotape. In the first session, after learning how to jump, the subject performs the jump in the condition without tape. Then the tape is attached to the subject and this time the jump is done with the tape. Two situations with and without tape will be randomly selected for people. After a week, the second session will begin. In the second session, the fatigue protocol will be applied randomly in two conditions with and without tape. Our fatigue protocol consists of 5 sets of consecutive jumps, and when the person cannot continue the protocol, it means that the person is tired. Intervention 2: For the sham tape group, a kinesiotape piece is used on the inside of the ankle. In the first session, after learning how to jump, the subject performs the jump in the condition without tape. Then the tape is attached to the subject and this time the jump is done with the tape. Two situations with and without tape will be randomly selected for people. After a week, the second session will begin. In the second session, the fatigue protocol will be applied randomly in two conditions with and without tape. Our fatigue protocol consists of 5 sets of consecutive jumps, and when the person cannot continue the protocol, it means that the person is tired.</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>Zeynab Nickpey</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>zeynabnickpey@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>Active non-athlete women (light aerobic activity three times a week), suffering from bilateral flexible flatfeet
Normal Body Mass Index (18.5-24.9)
Age 18-30</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of any lasting orthopedic or neurological damage in the lower limbs and spine
The difference in the actual length of the lower body is more than 1.5 centimeter
Significant congenital malformations in the lower limbs
Body mass index more than 24.9
Pain in the lower limbs or spine during the research period
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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: intervention includes kinesiotape. In the first session, after learning how to jump, the subject performs the jump in the condition without tape. Then the tape is attached to the subject and this time the jump is done with the tape. Two situations with and without tape will be randomly selected for people. After a week, the second session will begin. In the second session, the fatigue protocol will be applied randomly in two conditions with and without tape. Our fatigue protocol consists of 5 sets of consecutive jumps, and when the person cannot continue the protocol, it means that the person is tired.</i_keyword>
      <i_keyword>For the sham tape group, a kinesiotape piece is used on the inside of the ankle. In the first session, after learning how to jump, the subject performs the jump in the condition without tape. Then the tape is attached to the subject and this time the jump is done with the tape. Two situations with and without tape will be randomly selected for people. After a week, the second session will begin. In the second session, the fatigue protocol will be applied randomly in two conditions with and without tape. Our fatigue protocol consists of 5 sets of consecutive jumps, and when the person cannot continue the protocol, it means that the person is tired.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Biomechanical variables related to body movement activities such as walking and jumping. Timepoint: Before and after the functional fatigue protocol. Method of measurement: Force plate device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Navicular drop value. Timepoint: Before and after kinesio tape. Method of measurement: Difference between the distance of the navicular tuberosity to the ground in the sitting and standing positions.</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>2022-08-29</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>
