<?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>IRCT20220216054033N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-29</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Effect of Patellar Strap and Sports Tape on pain and functional performance in football players with Patellar Tendinopathy</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Patellar Strap and Sports Tape on pain and functional performance in football players with Patellar Tendinopathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62580</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: After selecting the subjects using Purposive sampling the included cases will randomly allocated into two groups by simple random sampling using Gold Fish bowl method. Participants will be informed about their registration Number. The participants group will be masked as A &amp; B by the Trainer/Assessor.  Pre and post Data will be collected and analyzed by the data analyst. After analysis the Groups will be unmasked, Blinding description: 34 Participants will be involved in my study using Purposive Sampling Technique.
2 groups of 17 participants each will be made and will be randomized using systematic sampling.
Outcome accessor will be blinded by not knowing the information about the groups  of the study. The Investigator will determine the information by the medical record number, assigned to each participant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patellar Tendinopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1, will include participants who will receive intervention in which patellar straps of different brands like Conwell, LiveUp, McDavid Knee Support Strap and CAMBIVO will be used to check its effectiveness on pain and functional performance. Intervention 2: Control group:   In Group 2, it will include participants who will receive intervention of Sports tapes like Sports Rayon Zinc Oxide tape, Fastoplast Sports Tape, Dr. Sethi and Rigid White Tapes will be used along with conventional treatment method of rest, icing, compression and elevation.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayyaba Mustafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>FMH Shadman</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>40050</zip>
        <telephone>+92 331 6267826</telephone>
        <email>tayyaba.mustafa123@gmail.com</email>
        <affiliation>Fatima Memorial Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muhammad Hashim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Quadi azam Industrial State Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>40050</zip>
        <telephone>+92 323 4071564</telephone>
        <email>muhammad.hashim@riphah.edu.pk</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>players with diagnosed case of patellar tendinopathy through ultrasound or mri.
players with age between 18 to 50 years of age.
players with pain in patellar tendon or its patellar or tibial insertion in one or both knees.
players having duration of symptoms exceeding 3 to 4 days</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>players with acute knee pain due any pathology.
chronic joint pathology.
players with knee joint surgeries.
players with patellar tendon reconstructive surgery
players who are unable to perform test due to any reason other than patellar tendinopathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M76.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Patellar tendinitis</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: Group 1, will include participants who will receive intervention in which patellar straps of different brands like Conwell, LiveUp, McDavid Knee Support Strap and CAMBIVO will be used to check its effectiveness on pain and functional performance.</i_keyword>
      <i_keyword>Control group:   In Group 2, it will include participants who will receive intervention of Sports tapes like Sports Rayon Zinc Oxide tape, Fastoplast Sports Tape, Dr. Sethi and Rigid White Tapes will be used along with conventional treatment method of rest, icing, compression and elevation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduction in pain of football player. Timepoint: Before intervention and 6 weeks after intervention. Method of measurement: For pain assessment:  numeric pain rating scale for functional assessment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Increased functional outcome of the athlete. Timepoint: Before intervention and after 6 weeks of intervention. Method of measurement: Victorian institute of sports assessment: Questionnaire for Functional Performance Assessment.</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>Riphah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-27</approval_date>
        <contact_name>Riphah International University</contact_name>
        <contact_address>Quaid e Azam Industrial State Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
