<?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>IRCT20240513061779N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-30</date_registration>
      <primary_sponsor>Shomal university</primary_sponsor>
      <public_title>Comparing the effects of two different balance training protocols on improving balance in deaf female students</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effects of core stability training and child-centered play therapy on improving static and dynamic balance in female deaf children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86381</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization with block size = 3 will be divided between the groups; the randomization list will be generated using the "Random allocation" software. So that first, the subjects will be grouped in consecutive blocks of fixed size of 3 in the order of their entry into the study. For each block, a random sequence of group assignments will be generated by specialized "Random allocation" software. This software ensures that the order of the groups within each block is completely random. Then, each new volunteer is assigned to one of the study groups based on their position in the current block and according to a pre-generated list. This method ensures that allocations remain balanced throughout the study and that the probability of allocation bias in short-term time intervals tends to zero, Blinding description: In order to prevent the Hawthorne and Avis effect, in the present study, the examiner (clinical caregiver) and the data analyst were unaware of the content and titles of the groupings.</study_design>
      <phase>4</phase>
      <hc_freetext>Congenital bilateral deafness.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 8 weeks of performing full-body core stability training based on body weight with a frequency of 3 sessions per week (30 minutes in the first 3 weeks to 45 minutes in the last 5 weeks). Intervention 2: Intervention group: 8 weeks of game-based exercises (including jogging, chasing, jumping) with a frequency of 3 sessions per week (30 minutes in the first 3 weeks to 45 minutes in the last 5 weeks). Intervention 3: Control group: daily routine without any special physical activity.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There are no plans to release it</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nader Hamedchaman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haraz street</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۶۱۶۱۸۴۵۹۶</zip>
        <telephone>+98 11 4420 3638</telephone>
        <email>nader.hamedchaman@gmail.com</email>
        <affiliation>Shomal university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nader Hamedchaman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haraz street</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۶۱۶۱۸۴۵۹۶</zip>
        <telephone>+98 11 4420 3638</telephone>
        <email>nader.hamedchaman@gmail.com</email>
        <affiliation>Shomal University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Documented history of absolute or severe deafness
Ability to walk independently
No physical disabilities</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>15 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Outfit the prerequisitive age range of 10 to 15 years old
Presence or emergence of other physical disabilities
Adding drug treatments that interfere with the hormonal profile or performance of volunteers</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Conductive hearing loss, bilateral</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 8 weeks of performing full-body core stability training based on body weight with a frequency of 3 sessions per week (30 minutes in the first 3 weeks to 45 minutes in the last 5 weeks)</i_keyword>
      <i_keyword>Intervention group: 8 weeks of game-based exercises (including jogging, chasing, jumping) with a frequency of 3 sessions per week (30 minutes in the first 3 weeks to 45 minutes in the last 5 weeks)</i_keyword>
      <i_keyword>Control group: daily routine without any special physical activity</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Error count in the functional test of standing with one foot on a hard surface. Timepoint: Before and 48 hours subsequent to the 8 weeks of balance training. Method of measurement: Field test of balance on a hard surface.</prim_outcome>
      <prim_outcome>Error count in the functional test of standing with one foot on a soft surface. Timepoint: Before and 48 hours subsequent to the 8 weeks of balance training. Method of measurement: Field test of balance on a soft surface.</prim_outcome>
      <prim_outcome>Error count in the functional test of tandem standing on a hard surface. Timepoint: Before and 48 hours subsequent to the 8 weeks of balance training. Method of measurement: Field test of balance on a hard surface.</prim_outcome>
      <prim_outcome>Error count in the functional test of tandem standing on a soft surface. Timepoint: Before and 48 hours subsequent to the 8 weeks of balance training. Method of measurement: Field test of balance on a soft surface.</prim_outcome>
      <prim_outcome>Functional test of Dynamic balance. Timepoint: Before and 48 hours after 8 weeks of balance training. Method of measurement: Field test 3 meters back and forth on a balance beam.</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>Shomal university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-12-02</approval_date>
        <contact_name>Ethics Committee of Sport Sciences Research Institute</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
