<?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>IRCT20240805062657N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-13</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of eight weeks of perceptual-motor exercises on the executive functions and learning motor skills of mentally retarded children.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of perceptual-motor exercises on the executive functions and learning motor skills of mentally retarded children.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78358</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The present research, after the implementation of 8 weeks of intervention (perceptual-motor exercises), in order to evaluate the durability of the interventions, after 2 months, the dependent variables will be evaluated again, Randomization description: In this research, the subjects were selected in an accessible and purposeful way and according to the desired criteria and by simple randomization, using a table of random numbers, and randomization on the web and using coded boxes with a random sequence in the experimental group. and control will be divided.</study_design>
      <phase>N/A</phase>
      <hc_freetext>People with mental disabilities.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, children will participate in eight weeks of perceptual-motor exercises, which include stretching exercises, perceptual-motor exercises (including: identification of different directions, static balance and dynamic balance, coordinated movements and simultaneous movements of throwing the ball at the target, receiving and passing the ball, targeted movements, throwing darts will be safe...) and training will be back to the original state. The exercises will be performed by the trainer and the children will coordinate their movements with the trainer and the group. Intervention 2: Control group: The subjects of the control group did not participate in the intervention after participating in the pre-test and only performed the daily routine program that was in accordance with the regular programs of 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only a part of the data, such as the information related to the main outcome or the like, can be shared after the completion of the project.

When:
The access period starts 9 months after the publication of the results and articles

To whom:
The data will be available to researchers.

Conditions:
The detailed information of the study can be provided to competent researchers interested in the field of mental retardation.

Where to obtain:
Correspond with farzad.mohammadi59@gmail.com .

How to obtain:
Competent and interested researchers can receive data documentation after publication of the work from the corresponding author by providing their academic information and identification.

Comments:
This clinical trial with the title "Effect of eight weeks of perceptual motor training on executive functions and motor skill learning of mentally retarded children" has not been previously registered anywhere else and has not been submitted anywhere else at the same time. We are very happy to register our clinical trial with IRCT. thank you.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzad Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abadan branch, Islamic Azad University, in front of Taleghani Hospital,Nurse Square,  Fieh, Station 12,  Abadan.</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۳۱۷۸۳۶۵۳۱</zip>
        <telephone>00986153360112-9</telephone>
        <email>Farzad.Mohammadi59@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzad Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abadan Branch, Islamic Azad University</address>
        <city>Abadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۳۱۷۸۳۶۵۳۱</zip>
        <telephone>+98 61 5336 0112</telephone>
        <email>Farzad.Mohammadi59@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obtaining consent from parents and individual satisfaction
IQ score 50 to 70
being right-handed
not having defects or physical disability
not having cardiovascular problems
not having autism problems and other problems that affect cognitive development
not having other problems that affect cognitive development
Age 7 to 10 years</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The withdrawal of students and parents at every stage of the research
not participating in practice sessions
not participating in pretest stage
not participating in post-test stage</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild intellectual disabilities</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, children will participate in eight weeks of perceptual-motor exercises, which include stretching exercises, perceptual-motor exercises (including: identification of different directions, static balance and dynamic balance, coordinated movements and simultaneous movements of throwing the ball at the target, receiving and passing the ball, targeted movements, throwing darts will be safe...) and training will be back to the original state. The exercises will be performed by the trainer and the children will coordinate their movements with the trainer and the group.</i_keyword>
      <i_keyword>Control group: The subjects of the control group did not participate in the intervention after participating in the pre-test and only performed the daily routine program that was in accordance with the regular programs of the center.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Learning movement skills. Timepoint: The measurement will be done in the pre-test stage and  post-test stage. Method of measurement: TGMD-3 test.</prim_outcome>
      <prim_outcome>Executive functions. Timepoint: The measurement will be done in the pre-test stage and  post-test stage. Method of measurement: Connors neuropsychological 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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-13</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University - Ahvaz Branch</contact_name>
        <contact_address>Address: Khuzestan province, Ahvaz city, Golestan highway, Farhang Shahr, Islamic Azad University, Ahvaz branch, Faculty of Nursing and Midwifery Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
