<?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>IRCT20250208064687N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-16</date_registration>
      <primary_sponsor>University of Tehran</primary_sponsor>
      <public_title>The Effect of Perceptual-Motor Training and tDCS on Executive Function and Motor Skills in Children with ADHD</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Perceptual-Motor Training and tDCS on Executive Functions and Motor Skills in Children with Attention Deficit Hyperactivity Disorder (ADHD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81926</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple Randomization Using SPSS Software

The following steps will be followed for simple randomization using SPSS software:

First, a random variable will be created using the Transform &gt; Compute Variable tool. This variable will be defined using the formula Trunc(RV.Uniform(0,1)*3)+1, which randomly assigns individuals to one of three groups (1, 2, or 3).

The data will then be sorted based on this variable using the Data &gt; Sort Cases tool.

Finally, participants will be randomly divided into three groups: the control group (number 1) and two experimental groups (numbers 2 and 3).

This method is a simple and transparent form of randomization, which will be used in the future for the implementation of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Attention Deficit Hyperactivity Disorder.</hc_freetext>
      <i_freetext>Intervention 1: The study was conducted in accordance with the latest version of the Declaration of Helsinki and approved by the Ethics Committee of the University of Tehran. The method of collecting data for the present study was fieldwork. Initially, written informed consent was obtained from the parents. Children also verbally expressed their willingness to participate in the study. Then, the participants were introduced to the objectives of the study and the scoring and implementation of the desired tests. Subsequently, the participants were randomly assigned to one of the tDCS stimulation group (1) and perceptual-motor training group (2). The present study included pre-test, intervention (practice), and post-test stages. Assessments were conducted before the start of the interventions and in the session after the interventions by another occupational therapist. This assessor was unaware of the objectives and content of the sessions during the study process, and after familiarization, in the pre-test stage, the Ulrich test (3rd edition) and the executive functions test (Stroop, Wisconsin, and N-back) were administered to the children in accordance with the existing guidelines, and then the parents completed the standard ADHD questionnaire. The intervention phase was conducted in 24 sessions. In the tDCS direct electrical stimulation group, participants received 24 sessions of 30-minute electrical stimulation of the DLPFC (F4-F3) and the primary motor cortex (M1) (C4-C3) (in this way, in anodic electrical stimulation, a direct current of 1.5 milliamperes is applied to the individual throughout the entire duration of the stimulation). The sessions were conducted 3 days a week. In the perceptual-motor training group, which was also conducted in 24 sessions of 45 minutes each session, 3 days a week, the participants performed the relevant exercises. The 10-20 International System was used to find the points. Immediately after the last session, the post-test phase was conducted in which the participants performed the desired tests. Intervention 2: Control group: Group 3 was the control group, which received no intervention. Intervention 3: Intervention group: Intervention group: Perceptual-motor exercises: The present study included pre-test, intervention (practice), and post-test phases. Assessments were conducted by another occupational therapist before the intervention and in the session after the intervention. The subjects were unaware of the concepts and content of the sessions during the study process, and after familiarization, in the pre-test phase, the Ulrich test (3rd edition) and the executive functions test (Stroop, Wisconsin, and N-back) were administered according to the existing instructions, and then the parents completed the standard attention deficit hyperactivity disorder questionnaire. The intervention phase consisted of 24 sessions. In the perceptual-motor exercises group, which was conducted in 24 sessions, each session lasting 45 minutes, 3 days a week, the participants performed the exercises. After the last session, the post-test phase was conducted in which the participants performed the desired tests.</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 It also depends on the opinions of other professors.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Shadfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gino Complex,Kamal Elmak Street, Pasdaran Street,</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617635413</zip>
        <telephone>+98 87 3328 9192</telephone>
        <email>reza.shadfar@ut.ac.ir</email>
        <affiliation>University of Tahran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Shadfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zino Complex, Kamal-ol-Molk Street, Pasdaran Street</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617635413</zip>
        <telephone>+98 87 3328 9192</telephone>
        <email>rezashadfar24@yahoo.co.uk</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>With ADHD Disorder</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>10 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having Other Diseases and Disorders
Range outside the age range of 7-10 years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, predominantly inattentive type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The study was conducted in accordance with the latest version of the Declaration of Helsinki and approved by the Ethics Committee of the University of Tehran. The method of collecting data for the present study was fieldwork. Initially, written informed consent was obtained from the parents. Children also verbally expressed their willingness to participate in the study. Then, the participants were introduced to the objectives of the study and the scoring and implementation of the desired tests. Subsequently, the participants were randomly assigned to one of the tDCS stimulation group (1) and perceptual-motor training group (2). The present study included pre-test, intervention (practice), and post-test stages. Assessments were conducted before the start of the interventions and in the session after the interventions by another occupational therapist. This assessor was unaware of the objectives and content of the sessions during the study process, and after familiarization, in the pre-test stage, the Ulrich test (3rd edition) and the executive functions test (Stroop, Wisconsin, and N-back) were administered to the children in accordance with the existing guidelines, and then the parents completed the standard ADHD questionnaire. The intervention phase was conducted in 24 sessions. In the tDCS direct electrical stimulation group, participants received 24 sessions of 30-minute electrical stimulation of the DLPFC (F4-F3) and the primary motor cortex (M1) (C4-C3) (in this way, in anodic electrical stimulation, a direct current of 1.5 milliamperes is applied to the individual throughout the entire duration of the stimulation). The sessions were conducted 3 days a week. In the perceptual-motor training group, which was also conducted in 24 sessions of 45 minutes each session, 3 days a week, the participants performed the relevant exercises. The 10-20 International System was used to find the points. Immediately after the last session, the post-test phase was conducted in which the participants performed the desired tests.</i_keyword>
      <i_keyword>Control group: Group 3 was the control group, which received no intervention.</i_keyword>
      <i_keyword>Intervention group: Intervention group: Perceptual-motor exercises: The present study included pre-test, intervention (practice), and post-test phases. Assessments were conducted by another occupational therapist before the intervention and in the session after the intervention. The subjects were unaware of the concepts and content of the sessions during the study process, and after familiarization, in the pre-test phase, the Ulrich test (3rd edition) and the executive functions test (Stroop, Wisconsin, and N-back) were administered according to the existing instructions, and then the parents completed the standard attention deficit hyperactivity disorder questionnaire. The intervention phase consisted of 24 sessions. In the perceptual-motor exercises group, which was conducted in 24 sessions, each session lasting 45 minutes, 3 days a week, the participants performed the exercises. After the last session, the post-test phase was conducted in which the participants performed the desired tests.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motor skills. Timepoint: Before the start of the intervention and after 8 weeks of intervention. Method of measurement: Ulrich Test (Third Edition).</prim_outcome>
      <prim_outcome>Working memory. Timepoint: Before the start of the intervention and after 8 weeks of intervention. Method of measurement: N-Back Test.</prim_outcome>
      <prim_outcome>Cognitive flexibility. Timepoint: Before the start of the intervention and after 8 weeks of intervention. Method of measurement: Wisconsin test.</prim_outcome>
      <prim_outcome>Response inhibition. Timepoint: Before the start of the intervention and after 8 weeks of intervention. Method of measurement: Stroop 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>خود شخص مسول</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-30</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University, Sari Branch</contact_name>
        <contact_address>Pasdaran Street, Kamal Elmak Street, Gino Complex sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
