<?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>IRCT20190802044406N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-16</date_registration>
      <primary_sponsor>Khurazmi university of Tehran</primary_sponsor>
      <public_title>The effect of Brailletonik exercises, treadmill and computer games on executive functions, motor and social skills</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Brailletonik exercises, treadmill and computer games on executive functions, motor and social skills of mentally retarded children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41284</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be based on randomized block design with block size 4 (using table of random permutations) and assignment ratio of 1: 1. To ensure that the assignment to each group will be kept confidential, after randomization, participants' codes will be covered by closed envelopes by a person who that unaware of the purpose of study. Until the intervention of the researcher and the participant, he or she will do not know in which group he will be placed. Subjects will be randomly divided into four groups of eight (8 in the Brailltonic group, 8 in the treadmill group, 8 in the computer game group, and 8 in the control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mental retardation.</hc_freetext>
      <i_freetext>Intervention 1: In this group, Brailletonic exercises will be used for intervention. Brighton exercises such as warm-up, coding, using six squares, and cooling will be performed for 45 minutes. In general, the warm-up is 10 minutes, the training is 30 minutes, and the general body cooling is 5 minutes. Exercise intensity start with 50-60% of maximal heart rate and at the end of the eighth week it will be tried to reach 70-80% of maximal heart rate based on research findings using Polar pacemaker. Intervention 2: In this group, treadmill exercises will be used for intervention. The group Ventures warm-ups, treadmill training, and cooling down for 45 minutes. In general, the warm-up is 10 minutes, the training is 30 minutes, and the general body cooling is 5 minutes. Exercise intensity start with 50-60% of maximal heart rate and at the end of the eighth week it will be tried to reach 70-80% of maximal heart rate based on research findings using Polar pacemaker. Intervention 3: In this group, the intervention will be a computer game. Computer gaming is a type of interactive entertainment performed by an electronic device equipped with a processor or micro controller. These types of games based on the style of play and graphics are divided into different forms, such as educational, racing, sports, etc. In this group, the game will be adapted from a puzzle game of type Farm and Castles 1.2 8.5473.21-2 for 45 minutes. Intervention 4: The control group will received no intervention and its members will be performed the same routine procedure as the center.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Manizhe Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kharazmi University</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>31979-37551</zip>
        <telephone>+98 26 3457 5014</telephone>
        <email>std-Ghasemi.m93@khu.ac.ir</email>
        <affiliation>Kharazmi University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Manizhe Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kharazmi University</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>31979-37551</zip>
        <telephone>+98 26 3455 0702</telephone>
        <email>std-ghassemi.m93@khu.ac.ir</email>
        <affiliation>Kharazmi University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of Educable Mental Disability (IQ score between 50 and 70)
Female gender
Age range from 8 to 11 years
Peer in terms of motor development</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>11 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnosis of any illness or mental and physical disorder (other than mental retardation) that may affect research results, such as the diagnosis of head trauma or symptoms of psychosis.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild mental retardation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this group, Brailletonic exercises will be used for intervention. Brighton exercises such as warm-up, coding, using six squares, and cooling will be performed for 45 minutes. In general, the warm-up is 10 minutes, the training is 30 minutes, and the general body cooling is 5 minutes. Exercise intensity start with 50-60% of maximal heart rate and at the end of the eighth week it will be tried to reach 70-80% of maximal heart rate based on research findings using Polar pacemaker.</i_keyword>
      <i_keyword>In this group, treadmill exercises will be used for intervention. The group Ventures warm-ups, treadmill training, and cooling down for 45 minutes. In general, the warm-up is 10 minutes, the training is 30 minutes, and the general body cooling is 5 minutes. Exercise intensity start with 50-60% of maximal heart rate and at the end of the eighth week it will be tried to reach 70-80% of maximal heart rate based on research findings using Polar pacemaker.</i_keyword>
      <i_keyword>In this group, the intervention will be a computer game. Computer gaming is a type of interactive entertainment performed by an electronic device equipped with a processor or micro controller. These types of games based on the style of play and graphics are divided into different forms, such as educational, racing, sports, etc. In this group, the game will be adapted from a puzzle game of type Farm and Castles 1.2 8.5473.21-2 for 45 minutes.</i_keyword>
      <i_keyword>The control group will received no intervention and its members will be performed the same routine procedure as the center.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Executive functions. Timepoint: At baseline and 60 days later. Method of measurement: stroop.</prim_outcome>
      <prim_outcome>Motor skills. Timepoint: At baseline and 60 days later. Method of measurement: Continuous Performance Test.</prim_outcome>
      <prim_outcome>Social skill. Timepoint: At baseline and 60 days later. Method of measurement: Vineland Adaptive Behavior Scale.</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>دانشگاه خوارزمی</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-06</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modarres University</contact_name>
        <contact_address>Jalal Ale Ahmad Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
