<?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>IRCT20210518051338N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-23</date_registration>
      <primary_sponsor>Riphah International University, Lahore</primary_sponsor>
      <public_title>Effects of Kinesiology taping with conventional rehabilitation program on lower extremity function and disability in athletes with chronic ankle instability</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Kinesiology taping with conventional rehabilitation program on lower extremity function and disability in athletes with chronic ankle instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56560</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects fulfilling the inclusion criteria will be enrolled after independent outcome assessor then, fish bowl method will be used for randomization. We simply write the names of all the members in a small-rolled piece of papers, then place it in a fish bowl. The subject's randomization method reduces the chances of bias group allocation, Blinding description: The study would be single blinded as assessor of the study will be kept blind of the treatment group to which the patient will be allocated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Foot &amp; Ankle Disability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group will get kinesiology taping done along the lateral side of the foot and around the back of the heel, this will be placed for a day. Prior to the treatment ultrasound therapy will be given for 10 minutes, after the end of the treatment participants will be advised to perform ankle active range of motion exercises, strengthening exercises with resistance bands, balance and coordination exercises( single leg stance exercise, static balance exercises) and then functional exercises(running, stair climbing). These exercises will be performed with 10 repetitions. Treatment will be given for 4 weeks (three sessions per week on alternative days). Intervention 2: Control group: This group will receive ultrasound therapy in the start of the treatment for 10 minutes.  at the end of the treatment participants will be advised to perform ankle active range of motion exercises, strengthening exercises with resistance bands, balance and coordination exercises( single leg stance exercise, static balance exercises) and then functional exercises(running, stair climbing). These exercises will be performed with 10 repetitions. Treatment will be given for 4 weeks (three sessions per week on alternative days).</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:
Effects of Kinesiology Taping with Conventional Rehabilitation Program on Lower Extremity Function and Disability in Athletes with Chronic Ankle Instability

When:
After Publication

To whom:
people working in academic institutions and researchers

Conditions:
on permission from investigator

Where to obtain:
Through email to Investigator yusra.arif.786@gmail.com

How to obtain:
Through email to Investigator yusra.arif.786@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tasneem shehzadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 111 747 424</telephone>
        <email>tasneem.shehzadi@riphah.edu.pk</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tasneem Shehzadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 111 747 424</telephone>
        <email>tasneem.shehzadi@riphah.edu.pk</email>
        <affiliation>Riphah International University, Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants with 18 to 40 years of age
Both genders
History of ankle sprain which last for more than 3 months
Ankle weakness, pain
Hop test positive
History of unilateral ankle sprain for at least once</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of ankle fracture
History of balance disorders
Any previous surgery of lower extremity
History of other musculoskeletal injuries</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.879</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified joint disorders, unspecified ankle and foot</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: This group will get kinesiology taping done along the lateral side of the foot and around the back of the heel, this will be placed for a day. Prior to the treatment ultrasound therapy will be given for 10 minutes, after the end of the treatment participants will be advised to perform ankle active range of motion exercises, strengthening exercises with resistance bands, balance and coordination exercises( single leg stance exercise, static balance exercises) and then functional exercises(running, stair climbing). These exercises will be performed with 10 repetitions. Treatment will be given for 4 weeks (three sessions per week on alternative days)</i_keyword>
      <i_keyword>Control group: This group will receive ultrasound therapy in the start of the treatment for 10 minutes.  at the end of the treatment participants will be advised to perform ankle active range of motion exercises, strengthening exercises with resistance bands, balance and coordination exercises( single leg stance exercise, static balance exercises) and then functional exercises(running, stair climbing). These exercises will be performed with 10 repetitions. Treatment will be given for 4 weeks (three sessions per week on alternative days)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Foot &amp; Ankle Disability. Timepoint: Before treatment and then on 4th week. Method of measurement: Foot and Ankle Disability Index (FADI) Score.</prim_outcome>
      <prim_outcome>Lower Extremity Function. Timepoint: Before treatment and then on 4th week. Method of measurement: Lower Extremity Function Scale (LEFS).</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>Riphah International University, Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-07</approval_date>
        <contact_name>Research &amp; Ethical Review Committee, Riphah College of Rehab. &amp; Allied Health Sciences.</contact_name>
        <contact_address>653-E1, Johar Town, Lahore. Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
