<?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>IRCT20230124057197N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-30</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Virtual Reality in Chronic Ankle Instability</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of virtual reality-based trainings and conventional trainings on anticipatory and compensatory strategies while ball kicking in soccer-players with chronic ankle instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68214</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: the participants are randomly assigned to either the intervention group or the control group with a 1:1 allocation ratio.randomization is performed using a web-based randomization service (WWW.randomization.com). Random allocation  is carried out by a third party not involved in the study.details of the allocated groups are written on cards and placed inside sequentially numbered,opaque,sealed envelopes.in this way ,the allocation sequence was concealed from the main researches, Blinding description: Third person out of the research will code data in a way that they are unclear.Then they will be handed to analyzer and he/she will analyze data with software, then the former third person  will put data in SPSS.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Ankle Instability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Patients will be treated  by Nintendo Wii fit for 12 Sessions(3 sessions,4 weeks) for 1hour.All in all They will  Play 6 games which Single leg extension and Torso twist are Categorized in Strengthening Games and table tilt,Soccer heading,Tightrope walk,Penguin fishing are categorized in balance group.Patients move the avatar and gain points  with shifting their weight on Wii board. Intervention 2: Control group: patients will do theraband strengthening exercises,stretching and jumping.they have to perform task while maintaining their balance on different surfaces.</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 is provided</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rezvane Faghihi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7,Yas Street., Behnam Street., Ayatollah Kashani Blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1471878454</zip>
        <telephone>+98 21 4407 6493</telephone>
        <email>rezvane.fa76@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rezvane Faghihi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7,Yas Street., Behnam Street., Ayatollah Kashani Blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1471878454</zip>
        <telephone>+98 21 4407 6493</telephone>
        <email>rezvane.fa76@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Soccer player with moderate to vigorous physical activity
History of  first   Unilateral Ankle Sprain  incident At least 12Month Before Enrollment(The Last Sprain Should be At least For 3month ago)
Feeling of instability or Recurrent Giving Way in the Past Year
Cumberland Ankle instability Tool Score &lt;=24
No History of Neurological or  Psychological  Impairments
No History of Surgery or Fracture in Ankle or lower limb</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>participants who refuse to participate in trial for any reason
participants who Refuse to Continue Participating Due to Pain or any other Reason
Acute inflammation/Pain</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Patients will be treated  by Nintendo Wii fit for 12 Sessions(3 sessions,4 weeks) for 1hour.All in all They will  Play 6 games which Single leg extension and Torso twist are Categorized in Strengthening Games and table tilt,Soccer heading,Tightrope walk,Penguin fishing are categorized in balance group.Patients move the avatar and gain points  with shifting their weight on Wii board.</i_keyword>
      <i_keyword>Control group: patients will do theraband strengthening exercises,stretching and jumping.they have to perform task while maintaining their balance on different surfaces.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Normalized Integrated Electromyography of Proneus Longous ,soleous,Rectus Femoris,Biceps Femoris,Gluteous Medious  of the Injured Leg. Timepoint: Before First Session of Intervention and 24-72 Hours After the Last Session. Method of measurement: DataLOG for Portable Data Acquisition and Monitoring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Covered Distance in Y-Balnce Test in  Anterior/Posterior-Medial and Posterior-Lateral Directions. Timepoint: Before The First Session of Intervention and  24-72 Hours After the Last Session. Method of measurement: Strip Meter.</sec_outcome>
      <sec_outcome>Feeling of ankle instability. Timepoint: Before The First Session of Intervention and  24-72 Hours After the Last Session. Method of measurement: Cumberland Ankle Instability Tool.</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>2023-01-21</approval_date>
        <contact_name>Research Ethiques Committees of School of Nursing and Midwifery &amp; Rehabilitation-Tehran University o</contact_name>
        <contact_address>6th floor, Central Building Tehran University of Medical  Science, Qods Street Cross Section, Keshavarz Blv Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
