<?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>IRCT20230703058650N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-17</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Comparative Effect of Kinesio taping with and without conventional physical therapy in obese women with pes planus.</public_title>
      <acronym>RCT</acronym>
      <scientific_title>Comparative Effect of Kinesio taping with and without conventional physical therapy in obese women with pes planus.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71872</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: No, Randomization description: By using computer generated random number table, patients will be randomly assigned into two groups. All
those random numbers will be enclosed in sealed envelopes. A third person (who will further not be the
part of research) will open envelops and the patients will be allocated to the mentioned group accordingly, Blinding description: An independent assessor, who will be a senior and experienced physiotherapist and further will not be the part of study will perform the assessment of patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pes Planus.</hc_freetext>
      <i_freetext>Intervention 1: Group A: This group will receive kinesio taping , Kinesio Tape (KT) applied In the prone position, the participants flexed their knee and 3 strips of Kinesio tape (Kinesio® TexGoldTM FP, U.S.A) with 100% tension in the middle were applied on the transverse arch, aiming to enhance its static stability. Another strip of Kinesio tape with 75% tension was applied on the tibialis posterior, from the fifth metatarsal head, around the navicular and posterior medial malleolus to half of the tibia. The tapes were warmed by rubbing them immediately after application to maximize adhesion. Intervention 2: Group B: This group will receive kinesio taping (KT) with conventional physical therapy exercises Heel raises: Patient was in standing position and has to perform heel raises 20 times. (Without shoes),TA Stretching: The patient was taken in supine position Researcher was positioned to side of the patient and applied a passive stretch leading to 30 sec hold and was repeated 5 times each session, Toe Spreading exercises: The patient was in sitting or standing position and shall be instructed to stabilize the ball of the foot on the ground while lifting and spreading out the toes, Frequency: 20 times, intensity: 5 sec holds, type of contraction: isometric contraction ,Toe extension exercises: The patient was in sitting or standing position and was instructed to lift the big toe against the floor. Frequency: 20 times, intensity: 5 sec holds, type of contraction: isometric contraction Each exercise will be of 2 sessions a day.</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 collected identified IPD

When:
Data will be available after the completion of study and will remain available till 6 months

To whom:
Data will be available for other people almost 6 months after the completion of study

Conditions:
The data/document could be used by communicating with the principle investigator "Zainab Nasrullah" on email address "zainabnasrullah123@gmail.com".

Where to obtain:
Zainab Nasrullah, zainabnasrullah123@gmail.com

How to obtain:
The data/document can be accessed through communicating with the principle investigator "Zainab Nasrullah" on email address "zainabnasrullah123@gmail.com".

Comments:
N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zainab Nasrullah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>the university of lahore main campus near bhobatian chowk</address>
        <city>LAHORE</city>
        <country1>Pakistan</country1>
        <zip>00</zip>
        <telephone>+92 308 1026277</telephone>
        <email>zainabnasrullah123@gmail.com</email>
        <affiliation>The University of Lahore, Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zainab Nasrullah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-km, Defence Road, Off Bhobatian Chowk , Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 308 1026277</telephone>
        <email>zainab.nasrullah@admin.uol.edu.pk</email>
        <affiliation>The university of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	Age of  young adults (25-60) years
•	Having a navicular drop distance
•	Obese Females Body mass index (BMI, kg/m2) above(&lt;25</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>•	Skeletal or structural injury of lower extremities
•	Ankle sprain or surgery within 6 months
•	Any nervous system diseases
•	Any lower limb deformities
•	Unwillingness to continue the study</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group A: This group will receive kinesio taping , Kinesio Tape (KT) applied In the prone position, the participants flexed their knee and 3 strips of Kinesio tape (Kinesio® TexGoldTM FP, U.S.A) with 100% tension in the middle were applied on the transverse arch, aiming to enhance its static stability. Another strip of Kinesio tape with 75% tension was applied on the tibialis posterior, from the fifth metatarsal head, around the navicular and posterior medial malleolus to half of the tibia. The tapes were warmed by rubbing them immediately after application to maximize adhesion.</i_keyword>
      <i_keyword>Group B: This group will receive kinesio taping (KT) with conventional physical therapy exercises Heel raises: Patient was in standing position and has to perform heel raises 20 times. (Without shoes),TA Stretching: The patient was taken in supine position Researcher was positioned to side of the patient and applied a passive stretch leading to 30 sec hold and was repeated 5 times each session, Toe Spreading exercises: The patient was in sitting or standing position and shall be instructed to stabilize the ball of the foot on the ground while lifting and spreading out the toes, Frequency: 20 times, intensity: 5 sec holds, type of contraction: isometric contraction ,Toe extension exercises: The patient was in sitting or standing position and was instructed to lift the big toe against the floor. Frequency: 20 times, intensity: 5 sec holds, type of contraction: isometric contraction Each exercise will be of 2 sessions a day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Navicular drop, Foot Functionality. Timepoint: Before intervention and after 4 weeks of intervention. Method of measurement: Staheliplanter Arch Index, Navicular Drop Test (NDT), Foot Function Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Foot Functionality. Timepoint: Before intervention and after 4 weeks of intervention. Method of measurement: Foot Function Index.</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-11</approval_date>
        <contact_name>Institutional review board</contact_name>
        <contact_address>1-km, Defence Road, Off Bhobatian Chowk , Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
