<?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>IRCT20200204046368N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-11</date_registration>
      <primary_sponsor>Arak university</primary_sponsor>
      <public_title>positive expectation, negative expectation and taping</public_title>
      <acronym></acronym>
      <scientific_title>The role of placebo and nocebo in the effectiveness of dynamic tape on the postural control, electrical muscle activity of selected muscles, and the performance of athletes with chronic ankle instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77171</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Prevention, Randomization description: Participants are required to visit the sports science laboratory at Arak University on three separate days. Evaluations will be conducted under three conditions: positive mental induction, negative mental induction, and neutral, over three different days (sessions). The lottery is used to determine which criteria will be used to evaluate the tests in each session. At the start of the first session, the subject selects one of three different conditions through a lottery, and the tests are carried out accordingly. In the second session, a draw is conducted between the two remaining conditions. Then, in the third session, the third condition is tested, Blinding description: The participants are unaware of the intervention due to their positive, negative, and neutral mental expectations. Additionally, the collected data is provided to the analysts in code form, and they are unaware of the evaluated mentalities.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ankel instability.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In this condition, dynamic type will be applied on the ankle. The test will be taken with the usual mentality of the person. Intervention 2: Intervention group 1: In this condition, dynamic type is applied on the ankle and positive mental expectation is induced to the participants. Intervention 3: Intervention group 2: In this condition, dynamic type is applied on the ankle and negative mental expectation is induced to the participants.</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 No further information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Raeisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Square, Arak University</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848177584</zip>
        <telephone>+98 86 3417 3492</telephone>
        <email>Z_raisi13@yahoo.com</email>
        <affiliation>Arak University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Raeisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Square, Arak University</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848177584</zip>
        <telephone>+98 86 3417 3492</telephone>
        <email>Z_raisi13@yahoo.com</email>
        <affiliation>Arak University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A history of ankle sprain that requires medical treatment twice or more
Feeling of fear and instability of ankle function
Obtaining a score less than or equal to 24 from the Cumberland Questionnaire (CAIT≤24)
Obtaining a score between -2 and +2 on a five-point Likert scale for individual mentality towards the influence of the taping</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a history of previous surgery in the lower limbs
Having a history of fractures and acute injuries of the musculoskeletal structure or joints of the lower limbs (such as sprains, fractures, etc.) in the three months leading up to the research led to the loss of at least one day of physical activity.
History of using dynamic tape</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.373</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other instability, unspecified ankle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In this condition, dynamic type will be applied on the ankle. The test will be taken with the usual mentality of the person.</i_keyword>
      <i_keyword>Intervention group 1: In this condition, dynamic type is applied on the ankle and positive mental expectation is induced to the participants.</i_keyword>
      <i_keyword>Intervention group 2: In this condition, dynamic type is applied on the ankle and negative mental expectation is induced to the participants.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Electromyographic activity of muscle. Timepoint: With positive expectation from the dynamic tape, with negative expectation from the dynamic tape, with usual expectation from the dynamic tape. Method of measurement: Electromyography.</prim_outcome>
      <prim_outcome>Postural control. Timepoint: With positive expectation from the dynamic tape, with negative expectation from the dynamic tape, with usual expectation from the dynamic tape. Method of measurement: Pedoscan.</prim_outcome>
      <prim_outcome>Functional performance. Timepoint: With positive expectation from the dynamic tape, with negative expectation from the dynamic tape, with usual expectation from the dynamic tape. Method of measurement: Functional test.</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>Arak university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-31</approval_date>
        <contact_name>Research Ethics Committee of Arak University</contact_name>
        <contact_address>Arak University, Karbala Boulevard, Basij Square Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
