<?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>IRCT20261006071316N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-08</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of virtual reality and in-person martial arts training on executive functioning in boys with conduct disorder</public_title>
      <acronym></acronym>
      <scientific_title>Virtual Reality–Based and In-Person Martial Arts Training for Executive Functioning in Boys With Conduct Disorder: A Three-Arm Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/93882</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After baseline assessment, participants will be individually allocated to the VR-based martial arts, in-person martial arts, or control group in a 1:1:1 ratio using block randomization. An independent researcher who will not be involved in recruitment, intervention delivery, or outcome assessment will generate the random allocation sequence before allocation. Assignments will be concealed in sequentially numbered, opaque, sealed envelopes, which will be opened in order after baseline assessment to reveal each participant’s allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Conduct disorder.</hc_freetext>
      <i_freetext>Intervention group 1: Participants will receive supervised virtual reality–based martial arts training using Pico 4 Enterprise headsets at a pediatric rehabilitation center. The program will include 21 sessions over 7 weeks, three sessions per week, lasting 30–50 minutes each. Sessions will comprise 5–10 minutes of warm-up, 20–30 minutes of striking, footwork, balance, coordination, and progressively complex movement sequences, followed by 5–10 minutes of cool-down and reflection. Two certified martial arts instructors will supervise moderate-intensity training and monitor discomfort. Virtual reality exposure will be paused or stopped if moderate or severe symptoms occur..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
De-identified participant-level data underlying the reported results will be shared, including group allocation and executive-function scores at baseline, post-intervention, and 30-day follow-up. Names, contact details, and other identifying information will be removed.

When:
Data will be available upon reasonable request from six months after publication of the main study results for a period of five years.

To whom:
Qualified researchers from academic, scientific, or industry institutions will be eligible to request access. Access will require an approved research proposal and a signed data-use agreement protecting participant confidentiality.

Conditions:
Data will be used only for approved secondary analyses, verification of findings, or meta-analyses. Requests will specify the research aim, required variables, and analysis plan. Users will maintain secure storage, make no attempt to identify participants, and neither redistribute the data nor use them beyond the approved purpose.

Where to obtain:
Requests will be submitted by email to Fatemeh Mirzaei at solalll.19966@gmail.com. Applicants will provide their name, institutional affiliation, research proposal, required data, and analysis plan

How to obtain:
Applicants will email Fatemeh Mirzaei at solalll.19966@gmail.com, providing their institutional affiliation, research aim, required data, and analysis plan. Requests will be reviewed within four weeks. Following approval and signing of a data-use agreement, de-identified data will be transferred securely within two weeks. For complete requests, the entire process will take up to six weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South of Lashgar Intersection, South Kargar St., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333715876</zip>
        <telephone>+98 21 5577 8543</telephone>
        <email>solalll.19966@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South of Lashgar Intersection, South Kargar St., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333715876</zip>
        <telephone>+98 21 5577 8543</telephone>
        <email>solalll.19966@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants will be boys aged 7–11 years
Conduct disorder will be confirmed by a licensed child psychologist or psychiatrist using DSM diagnostic criteria
Participants will be physically able to safely perform moderate-to-vigorous physical activity
Participants will have no contraindications to virtual reality exposure
Written informed consent will be obtained from a parent or legal guardian
Age-appropriate assent will be obtained from each child</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>11 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Children with major neurological disorders will not be enrolled
Children with severe sensory or motor impairments will not be enrolled
Children with acute psychiatric instability requiring immediate intervention will not be enrolled
Children with any comorbid psychiatric diagnosis, including ADHD, oppositional defiant disorder, or anxiety disorders, will not be enrolled</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F91.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Conduct disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Participants will receive supervised virtual reality–based martial arts training using Pico 4 Enterprise headsets at a pediatric rehabilitation center. The program will include 21 sessions over 7 weeks, three sessions per week, lasting 30–50 minutes each. Sessions will comprise 5–10 minutes of warm-up, 20–30 minutes of striking, footwork, balance, coordination, and progressively complex movement sequences, followed by 5–10 minutes of cool-down and reflection. Two certified martial arts instructors will supervise moderate-intensity training and monitor discomfort. Virtual reality exposure will be paused or stopped if moderate or severe symptoms occur.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Behavior Regulation Index (BRI) T-score will be assessed using the BRIEF-2 Parent Form. Timepoint: Measurements will be taken at baseline before the intervention, immediately after the 7-week intervention, and 30 days after its completion. Method of measurement: The Parent Form of the Behavior Rating Inventory of Executive Function, Second Edition, will be completed by a parent or legal guardian to obtain the standardized score for the Behavior Regulation Index.</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>university of tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-05-03</approval_date>
        <contact_name>Research Ethics Committee of the Sport Sciences Research Institute (SSRI)</contact_name>
        <contact_address>No. 3, Fifth Alley (Sedrus), Mir Emad St., Shahid Motahari St., Abbas Abad–Andisheh Neighborhood Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
