<?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>IRCT20210224050481N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-03</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison effect of Mulligan tape and Kinesiotape in patients with chronic ankle instability</public_title>
      <acronym></acronym>
      <scientific_title>Comparison effect of Mulligan tape and Kinesiotape on the neuromuscular control in response to unpredictable perturbation in patients with chronic ankle instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>23</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54599</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each subject receives all treatments (control, Malignant type, and Kinesiotape), in a random order. Simple randomization is done by sealed envelopes containing the treatment allocation, Blinding description: Data collection will be done by the lead researcher and data analysis will be done by another person in order to be a single blind study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Ankle Instability.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group (Kinesio Tape group)- The kinesio type is placed on the Proneus Langus and Brevis and the anterior tibialis muscles for 24 hours with a tension of 35% ٪-25% from the origin to insertion of the muscle. Intervention 2: Second intervention group (Mulligan tape)-A painless posterior, lateral and superior glide is applied to the fibula in the inferior tibiofibular joint and then the tip is closed around the ankle. Intervention 3: Control group (Without Tape)- In this group, the patient does not receive treatment.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is not more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Roghaye Shadegani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 29, West 198 St, Bagheri Highway, Tehranpars</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1686937411</zip>
        <telephone>+98 21 7729 8015</telephone>
        <email>Roghaye_h92@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roghaye Shadegani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 29, West 198 St, Bagheri Highway, Tehranpars</address>
        <city>Teharn</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1686937411</zip>
        <telephone>+98 21 7729 8015</telephone>
        <email>Roghaye_h92@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18 to 35 years old
The initial sprain must have occurred at least 12months prior to the study enrollment
At least 1 ankle sprain was associated with inflammatory symptoms
Having ‘‘giving way’’ or ‘‘feeling of instability.
At least 1 ankle sprain resulted in at least 1 interrupted day of desired physical activity
The most recent injury must have occurred more than 3 months before enrollment in the study.
Having unilateral ankle sprain</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A history of previous surgery to the musculoskeletal structures in either lower extremity
A history of fracture in either lower extremity requiring realignment
Acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 3 months that affected joint integrity and function and resulted in at least 1 day of interrupted desired physical activity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group (Kinesio Tape group)- The kinesio type is placed on the Proneus Langus and Brevis and the anterior tibialis muscles for 24 hours with a tension of 35% ٪-25% from the origin to insertion of the muscle.</i_keyword>
      <i_keyword>Second intervention group (Mulligan tape)-A painless posterior, lateral and superior glide is applied to the fibula in the inferior tibiofibular joint and then the tip is closed around the ankle.</i_keyword>
      <i_keyword>Control group (Without Tape)- In this group, the patient does not receive treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time of short and medium latency response. Timepoint: Before and 24 hours after treatment. Method of measurement: The time of medium and short latency response will be calculated based on a Baseline-Based Method.                                                                                                      Thus, the time of short latency response is considered as a moment that Electromyography (EMG) activity will higher than the mean value plus 3 standard deviations (SD) and must be above the threshold at least 10 ms.                                                                                         The time of medium latency response is considered as a moment that Electromyography (EMG) activity will higher than the mean value plus 3 standard deviations (SD) and Stay above the threshold at least 20 ms. The mean value was assessed in the first 20 ms after the beginning of the short latency response.</prim_outcome>
      <prim_outcome>Amplitude of short and medium latency response. Timepoint: Before and 24 hours after treatment. Method of measurement: The amplitude of medium and short latency response will be calculated based on a Root Mean Square.                                                                       Two 20 millisecond (ms) windows were defined. The first window started at the onset of the short latency response and the second window started 30 ms later after the onset of the short latency response. The 10 ms division between the two windows.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Antagonist co-activation during short and medium latency response. Timepoint: Before and 24 hours after treatment. Method of measurement: The Antagonist Co-activation for Peroneus and Tibialis Anterior Muscles The Antagonist Co-activation for Tibialis Anterior and soleus Muscles                                                                                                we will measure with formula.</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>2021-02-20</approval_date>
        <contact_name>Ethics committee of  Tehran University of Medical Sciences</contact_name>
        <contact_address>District 12, Enghelab St, Pich-e-Shemiran، Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
