<?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>IRCT20230124057209N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-22</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of exergame and balance training on dynamic postural stability</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of exergame and balance training on dynamic postural stability during jump landing in athletes with chronic ankle instability</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74055</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of individuals will be done through the randomization.com website using a block randomization method with the block size of 4.After the initial assessment, people are randomly placed in one of the two groups according to the order of their entry into the study. Additionally, to ensure blinding, opaque sealed and numbered envelopes are used, which will be provided to participants by the secretary who is not aware of the study, Blinding description: Participants are not blind, and due to the study's design, therapist blinding is not possible. The assessor is blinded. In this way, the assessor is different from the therapist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Ankle Instability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The participant stays on the balance board of the Nintendo Device(Nintendo Co.Ltd., Kyoto, Japan) and plays 12 games each game has three difficulty levels (beginner, advanced, and expert), each level having four sub-levels (unstable, amateur, professional, and champion). The participant's level is determined based on the number of stars: 1 star (unstable), 2 stars (amateur), 3 stars (professional), and 4 stars (champion). If a participant is capable of playing a game at a certain level, they advance to the next level. The selection order of games in each session is based on the participants' preferences. Intervention 2: Control group:In this group, participants will perform a series of routine exercises over 12 sessions, with each session lasting one hour and conducted three times a week. The exercises include stretching of the gastrocnemius and soleus muscles, dorsiflexion and plantar flexion resistance exercises with a resistance band, neuromuscular exercises such as standing on one foot with eyes open and closed, ball throwing and shooting, and progressive balance exercises such as single-leg hops and jumps with a target on one foot. The exercises have varying levels of difficulty and progress over time.</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 no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sadaf Sepasgozar Sarkhosh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran university's medical dormitory,North kargar Ave,AmirAbad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439955975</zip>
        <telephone>+98 911 829 5466</telephone>
        <email>sadaf.sepasgozar@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roya Khanmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, District 12, Enghelab Street , Pich-E-Shemiran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6511111489</zip>
        <telephone>+98 21 7753 4133</telephone>
        <email>Rkhanmohammadi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range of 18-40 years
Both genders
Amateur athletes (volleyball player, basketball player, or football player) engaging in moderate to vigorous physical activity (at least 3 times per week, each session lasting more than 30 minutes
History of unilateral ankle sprain, at least 12 months prior to study entry (no more than 3 months since the last sprain at the time of study entry)
Experience of recurrent episodes of ankle giving way or feelings of instability and having symptoms such as weakness, and decreased performance over the past year
Scoring 24 or lower on the Cumberland Ankle Instability Tool</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of surgery or fractures in the ankle or lower extremity based on the patient's self-report
No history of training with video games</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S93.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain of ankle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The participant stays on the balance board of the Nintendo Device(Nintendo Co.Ltd., Kyoto, Japan) and plays 12 games each game has three difficulty levels (beginner, advanced, and expert), each level having four sub-levels (unstable, amateur, professional, and champion). The participant's level is determined based on the number of stars: 1 star (unstable), 2 stars (amateur), 3 stars (professional), and 4 stars (champion). If a participant is capable of playing a game at a certain level, they advance to the next level. The selection order of games in each session is based on the participants' preferences.</i_keyword>
      <i_keyword>Control group:In this group, participants will perform a series of routine exercises over 12 sessions, with each session lasting one hour and conducted three times a week. The exercises include stretching of the gastrocnemius and soleus muscles, dorsiflexion and plantar flexion resistance exercises with a resistance band, neuromuscular exercises such as standing on one foot with eyes open and closed, ball throwing and shooting, and progressive balance exercises such as single-leg hops and jumps with a target on one foot. The exercises have varying levels of difficulty and progress over time.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>AP/ML/ vertical and resultant Stability Index during lateral jump landing. Timepoint: Before starting the intervention and 48 h after the last session. Method of measurement: Force Plate device(BertecCorporation,Columbus, OH, USA).</prim_outcome>
      <prim_outcome>AP/ML/ vertical and resultant Time to Stabilization during lateral jump landing. Timepoint: Before starting the intervention and 48 h after the last session. Method of measurement: Force Plate device(BertecCorporation,Columbus, OH, USA).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Kinesiophobia. Timepoint: Before starting the intervention and 48 h after the last session. Method of measurement: Tampa Scale.</sec_outcome>
      <sec_outcome>The Time spent in lateral jump test. Timepoint: Before starting the intervention and 48 h after the last session. Method of measurement: Chronometer.</sec_outcome>
      <sec_outcome>The Distance traveled in single leg jump test. Timepoint: Before starting the intervention and 48 h after the last session. Method of measurement: Tape Measure.</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>School of Nursing and Midwifery and School of Rehabilitation - Tehran University of Medical Sciences</contact_name>
        <contact_address>Research and Technology Affairs Department, Room 605, 6th Floor, Tehran University of Medical Sciences Headquarters Building, Intersection of Keshavarz Boulevard and Ghods Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
