<?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>IRCT20180618040143N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-03</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Cognitive and Physical Rehabilitation Training on Hyperactive Children Attention</public_title>
      <acronym>ADHD</acronym>
      <scientific_title>Effect of Cognitive Rehabilitation Training, Physical Training and Concurrent Training (Cognitive Rehabilitation Games and Physical Training) on Sustained, Selective and Shifting Attentions of Hyperactive Children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>55</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50278</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple random using a random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>attention deficit hyperactivity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In the pre-test,  Integrated Visual and Auditory Continuous Performance Test, Wisconsin Card Sorting Test and Stroop test will be taken. The cognitive rehabilitation program includes the implementation of working memory training software in 16 sessions of 60 minutes at the school and the sessions will be held intensively 3 sessions per week. Then the post-test will be similar to the pre-test. Intervention 2: Intervention group 2: In the pre-test,  Integrated Visual and Auditory Continuous Performance Test, Wisconsin Card Sorting Test and Stroop test will be taken. The training protocol includes games such as chair play, game train, helmet game, jump in the ring, hand gesture movement in 16 sessions of 60 minutes at the school and the sessions will be held intensively 3 sessions per week. Then the post-test will be similar to the pre-tes. Intervention 3: Intervention group 3: In the pre-test,  Integrated Visual and Auditory Continuous Performance Test, Wisconsin Card Sorting Test and Stroop test will be taken. The Cognitive Rehabilitation and Physical Training program consists of a combination of two programs that are performed in one training session in such a way that 30 minutes of cognitive rehabilitation training protocol and 30 minutes of physical training protocol. 16 sessions of 60 minutes are taught at the school and the sessions will be held intensively 3 sessions per week. Then the post-test will be similar to the pre-tes. Intervention 4: Control group: The control group was followed up and did not receive any intervention.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mandana Sangari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17 shahrivar Ave</address>
        <city>Chalous</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4661961367</zip>
        <telephone>+98 11 5224 8782</telephone>
        <email>mandana.sangari@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mandana Sangari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17 sharivar Ave</address>
        <city>Chalous</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4661961367</zip>
        <telephone>+98 11 5224 8782</telephone>
        <email>mandana.sangari@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 9 to 12 years old
Attention Deficit/Hyperactivity Disorder
Willingness to participate in the study (consent from parents)
Not using stimulants to treat ADHD</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>12 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absence of more than two sessions in the research process
Changing treatment status and medication use</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F90.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Attention-deficit hyperactivity disorder, unspecified type</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: In the pre-test,  Integrated Visual and Auditory Continuous Performance Test, Wisconsin Card Sorting Test and Stroop test will be taken. The cognitive rehabilitation program includes the implementation of working memory training software in 16 sessions of 60 minutes at the school and the sessions will be held intensively 3 sessions per week. Then the post-test will be similar to the pre-test.</i_keyword>
      <i_keyword>Intervention group 2: In the pre-test,  Integrated Visual and Auditory Continuous Performance Test, Wisconsin Card Sorting Test and Stroop test will be taken. The training protocol includes games such as chair play, game train, helmet game, jump in the ring, hand gesture movement in 16 sessions of 60 minutes at the school and the sessions will be held intensively 3 sessions per week. Then the post-test will be similar to the pre-tes</i_keyword>
      <i_keyword>Intervention group 3: In the pre-test,  Integrated Visual and Auditory Continuous Performance Test, Wisconsin Card Sorting Test and Stroop test will be taken. The Cognitive Rehabilitation and Physical Training program consists of a combination of two programs that are performed in one training session in such a way that 30 minutes of cognitive rehabilitation training protocol and 30 minutes of physical training protocol. 16 sessions of 60 minutes are taught at the school and the sessions will be held intensively 3 sessions per week. Then the post-test will be similar to the pre-tes</i_keyword>
      <i_keyword>Control group: The control group was followed up and did not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sustained attention. Timepoint: One day before the start of the training intervention (pre-test) and after the last training session (post-test). Method of measurement: The Integrated Visual and Auditory (IVA) Continuous Performance Test (CPT).</prim_outcome>
      <prim_outcome>Selective attention. Timepoint: One day before the start of the training intervention (pre-test) and after the last training session (post-test). Method of measurement: Stroop test.</prim_outcome>
      <prim_outcome>Shifting attention. Timepoint: One day before the start of the training intervention (pre-test) and after the last training session (post-test). Method of measurement: Wisconsin Card Sorting 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>Islamic Azad University, Chalous Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-14</approval_date>
        <contact_name>Sport Sciences Research Institute of Iran</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
