<?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>IRCT20220920055996N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-18</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of a course of local adaptive games on basic skills, cognitive and behavioral characteristics in mentally retarded people.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a course of local adaptive games on basic skills, cognitive and behavioral characteristics in mentally retarded people.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66062</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Participants will be randomly assigned to two experimental groups and a control group with a 1:1 allocation ratio. Block randomization method will be used for random allocation of participants. The name of the software is random allocation software. We put the data into the software and then the software does it, Blinding description: After allocation it was not possible to keep the trainer bilnd to each participant's allocated intervention. But the evalutor remained bilnd. According to the evaluator's opinion, this study was blinded in order not to enter incorrect information or borrowing that may occur in any person, so that it can be done without information about the purpose of this research and the purpose of the tests.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mentally retarded children.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The experimental intervention group participated in the local indigenous exercises and games and rhythmic games and participated in the pre-test in the first session of the intervention and will participate in the post-test after 12 weeks at the end of the intervention. Intervention 2: Control group: In this group, there are no interventions and only at the beginning of the interventions, the intervention group will participate in the pre-test and after 12 weeks they will participate in the post-test.</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:
The data file of the participants is in the form of a complete Excel, in which the children's history, underlying disease and surgical history, and the degree of mental retardation are fully stated. The informed consent form will be designed and available to each participant. After completing the intervention steps, a complete report of the clinical interventions will be prepared and documented in an accessible file.

When:
All the documentary files will be available after the interventions and after the results and approval of the relevant judges and professors and after printing.

To whom:
People related to this research will be allowed to access, such as supervisors and advisors and referees, in addition to the details of the participants, other researchers working in academic and scientific institutions will have the necessary access.

Conditions:
Access to all parts of this study will be granted solely for treatment and to supplement and improve research.

Where to obtain:
To get information, you can refer to the email address fakhroldin.asadi@yahoo.com.

How to obtain:
Applicants can access the information after one working week after entering the email to the entered email address.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fakhroldin Asadi Farsani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>JQRM+HV3 Khorasgan, Isfahan, Isfahan Province</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>fakhroldin.asadi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Namazi zade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Blvd, Arghavanieh Ave, Estern Jey St, Esfahan Town</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>drmnamazi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Absence of cardiovascular disease
Not having any neurological disorder
Not having movement problems and walking independently
Education in primary schools for exceptional children in Chaharmahal and Bakhtiari province
Having the criteria for diagnosing the disorder based on the cutoff score
Parental consent
Age 8 to 12 years</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The occurrence of orthopedic problems for the participants
Parents' unwillingness to cooperate despite initial consent
Failure to attend the post-examination on time
The number of absences of more than 3 sessions during the exercise protocol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The experimental intervention group participated in the local indigenous exercises and games and rhythmic games and participated in the pre-test in the first session of the intervention and will participate in the post-test after 12 weeks at the end of the intervention.</i_keyword>
      <i_keyword>Control group: In this group, there are no interventions and only at the beginning of the interventions, the intervention group will participate in the pre-test and after 12 weeks they will participate in the post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The IQ of mentally retarded children. Timepoint: The first session will be taken at the beginning of the pre-test intervention and the post-test will be taken after 12 weeks of the end of the intervention. Method of measurement: Using Raven's progressive matrices test in adult form.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The level of self-efficacy of mentally retarded children. Timepoint: A pre-test will be taken in the first session and a post-test will be taken after 12 weeks of intervention. Method of measurement: Wheeler and Led questionnaire will be used to measure self-efficacy.</sec_outcome>
      <sec_outcome>The level of aggression of mentally retarded children. Timepoint: A pre-test will be taken in the first session and a post-test will be taken after 12 weeks of intervention. Method of measurement: Aggression questionnaire of mentally retarded children was used.</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>Fakhruddin Asadi Farsani</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-25</approval_date>
        <contact_name>Ethics Committee of Azad University of Khorasgan branch</contact_name>
        <contact_address>University Blvd, Arghavanieh Ave, Eastern Jey Str, Esfahan Town Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
