<?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>IRCT20211018052805N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-17</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of Kinesio tape on flexible flatfoot</public_title>
      <acronym></acronym>
      <scientific_title>Comparison Between Effects of Tibialis Posterior Kinesio Taping and Fibularis Longus Kinesio Taping on Dynamic Components and Foot Posture in Young Individuals with Flexible Flatfoot</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59492</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the initial assessments, the people will be randomly assigned to one of the two groups of tibialis posterior Kinesio taping and fibularis longus Kinesio taping (method: simple randomization - unit: individual). An envelope containing blue paper and another envelope containing red paper (randomization tool: sealed envelope) will be given to each person. Each person choosing the envelope containing blue or red paper will be assigned to the tibialis posterior Kinesio taping group or fibularis longus Kinesio taping group, respectively, Blinding description: The study will be single-blinded. In this way, the participants do not know to which group they will be allocated. However, the therapist assessing the outcome measures and the data analyzer know each participant’s group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Flexible Flatfoot.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: For the tibialis posterior muscle Kinesio taping, the person lies in a supine position and actively dorsiflexes and everts the ankle, and at the same time, Kinesio tape will be applied on the muscle. Kinesio taping will be started from the half of the tibia bone, passing behind the medial malleolus. Ultimately the Kinesio taping process will be finished at the fifth metatarsal head after passing over the navicular bone. A piece of I-shaped tape (TEMTEX, South Korea) with 35 percent tension plus no tension at both ends will be used. Then, people will rest for 30 minutes in a sitting position. After 30 minutes, reevaluation will be performed. A physical therapist will apply Kinesio tape for all of the people. Intervention 2: Intervention group 2: For the fibularis longus muscle Kinesio taping, the person lies in a supine position and actively plantarflexes and inverts the ankle, and at the same time, Kinesio tape will be applied on the muscle. Kinesio taping will be started from the fibular head, passing behind the lateral malleolus. Ultimately the Kinesio taping process will be finished at the first metatarsal base. A piece of I-shaped tape (TEMTEX, South Korea) with 35 percent tension plus no tension at both ends will be used. Then, people will rest for 30 minutes in a sitting position. After 30 minutes, reevaluation will be performed. A physical therapist will apply Kinesio tape for all of the people.</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:
All data is potentially shareable after making individuals unidentified.

When:
The access period starts three months after the articles are published.

To whom:
For researchers working in academic, scientific, and hospital institutions

Conditions:
It's for researchers who work in the field of lower limb biomechanical impairments and the field of Kinesio tape.

Where to obtain:
Applicants for documentation can contact Mr. Alireza Tahmasbi via email: ar-tahmasebi@razi.tums.ac.ir

How to obtain:
Once they have the necessary criteria, the information will be provided to them within a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Tahmasbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Piche Shemiran, Enghelab Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>ar-tahmasebi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Tahmasbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Piche Shemiran, Enghelab Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>ar-tahmasebi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18-40 year old people
Navicular drop test &gt;= 10 mm
Foot posture index score between +6 to +12
Positive toe raise test
BMI between 20-25</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Ankle injury in the last six months
History of foot surgery
Foot injury due to systemic, inflammatory and infectious diseases
Foot deformities include hallux valgus, hammer toe, claw toe
Pregnancy
Ankle pain during the study
Static standing and walking problems
Kinesio tape sensitivity
Refuse to participate in the study or cancel continuing treatment</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: For the tibialis posterior muscle Kinesio taping, the person lies in a supine position and actively dorsiflexes and everts the ankle, and at the same time, Kinesio tape will be applied on the muscle. Kinesio taping will be started from the half of the tibia bone, passing behind the medial malleolus. Ultimately the Kinesio taping process will be finished at the fifth metatarsal head after passing over the navicular bone. A piece of I-shaped tape (TEMTEX, South Korea) with 35 percent tension plus no tension at both ends will be used. Then, people will rest for 30 minutes in a sitting position. After 30 minutes, reevaluation will be performed. A physical therapist will apply Kinesio tape for all of the people.</i_keyword>
      <i_keyword>Intervention group 2: For the fibularis longus muscle Kinesio taping, the person lies in a supine position and actively plantarflexes and inverts the ankle, and at the same time, Kinesio tape will be applied on the muscle. Kinesio taping will be started from the fibular head, passing behind the lateral malleolus. Ultimately the Kinesio taping process will be finished at the first metatarsal base. A piece of I-shaped tape (TEMTEX, South Korea) with 35 percent tension plus no tension at both ends will be used. Then, people will rest for 30 minutes in a sitting position. After 30 minutes, reevaluation will be performed. A physical therapist will apply Kinesio tape for all of the people.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Navicular drop test score. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Index card and ruler.</prim_outcome>
      <prim_outcome>Foot posture index score. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Observation.</prim_outcome>
      <prim_outcome>Y balance test score. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Meter.</prim_outcome>
      <prim_outcome>Timed up and go test score. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: stopwatch.</prim_outcome>
      <prim_outcome>Mean length/width of gait line. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Moticon insole and software.</prim_outcome>
      <prim_outcome>Mean and maximum total force of stance phase. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Moticon insole and software.</prim_outcome>
      <prim_outcome>Mean double support time. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Moticon insole and software.</prim_outcome>
      <prim_outcome>Mean stance and swing duration. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Moticon insole and software.</prim_outcome>
      <prim_outcome>Center of pressure amplitude in mediolateral direction. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Moticon insole and software.</prim_outcome>
      <prim_outcome>Center of pressure amplitude in anteroposterior direction. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Moticon insole and software.</prim_outcome>
      <prim_outcome>Center of pressure standard deviation in mediolateral direction. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Moticon insole and software.</prim_outcome>
      <prim_outcome>Center of pressure standard deviation in anteroposterior direction. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Moticon insole and software.</prim_outcome>
      <prim_outcome>Mean center of pressure velocity. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Moticon insole and software.</prim_outcome>
      <prim_outcome>Center of pressure trace length. Timepoint: At the beginning of the study and after 30 minutes of intervention. Method of measurement: Moticon insole and software.</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>2021-10-18</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine, Tehran University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
