<?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>IRCT20181211041929N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-30</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>Motor Skills Leaning in High Functioning Autism Spectrum Disorder Children</public_title>
      <acronym></acronym>
      <scientific_title>Predictive Control of Movement in High Functioning Autism Spectrum Disorder Children: Combine Approach for Motor Skills Leaning</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35893</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: A) Randomization method: Simple randomization (random number table)
B) Building Random sequence method: Determining beforehand reading the table (up, down, right, left) then we start reading numbers from 0 to 50 intervention groups and 51 to 99 control groups.
C) Randomization unit: Individual
D) Randomization Tool: Random number table, sealed envelopes (for making random sequences)
E) Concealment: Snose method
A number of aluminum-covered envelopes (in order to keep the contents of the envelopes unclear) are prepared and each random sequence created on the card is recorded and the cards are inserted into the envelopes respectively. In order to maintain a random sequence, the numbering of the envelopes on the outer surface is done in the same order. Finally, the flap is closed in pockets and placed in the box, respectively. At the time of registration of the participants, according to the order in which the participants are entered, one of the envelopes is opened and the allocated group of that participant is made known.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Autism spectrum disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Children will take part in motor imagery training that will be delivered in 5 sessions per hour In addition common occupational therapeutic and psychological interventions based on ABA method. Intervention 2: Control group: The children of this experimental group are engaged in their common occupational therapeutic and psychological interventions  based on ABA method.</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 that the output of the movement assessment battery for children is without identifying the subjects of the subject.

When:
6 months after printing results

To whom:
All interested persons

Conditions:
There is no specific item.

Where to obtain:
Send an email to saeid.ahar@gmail.com

How to obtain:
After posting, it will take two weeks for the documentation to reach.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeid Ahar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kharazmi University, No.43. South Mofatteh Ave, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1571914911</zip>
        <telephone>+98 21 8832 9220</telephone>
        <email>saeid.ahar@gmail.com</email>
        <affiliation>The university of Kharazmi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farhad Ghadiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Address: No. 43, Shahid Mofatteh Ave., Kharazmi University, Faculty of Physical Education &amp; Sport Sciences, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1571914911</zip>
        <telephone>+98 21 2225 8081</telephone>
        <email>ghadiri671@gmail.com</email>
        <affiliation>The University of Kharazmi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All are right hands
don't have skeletal- muscular injuries
range of age between 8 to 13 years
sex: male
Do not have a history of engagement in protocols of motor imagery training
Have a specific schedule for sleeping and eating
Based on DSM-V criteria, autism spectrum disorder has been identified for these children.</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>13 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>another disorder, such as epilepsy, cerebral palsy or Down syndrome, and all kinds of mental retardation have been diagnosed For them
Have a history of basketball practice
Have a history of admission to mental hospitals
Have a history of using psychoactive drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F84.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Autistic disorder</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: Children will take part in motor imagery training that will be delivered in 5 sessions per hour In addition common occupational therapeutic and psychological interventions based on ABA method.</i_keyword>
      <i_keyword>Control group: The children of this experimental group are engaged in their common occupational therapeutic and psychological interventions  based on ABA method.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Static and dynamic balance. Timepoint: Before the intervention and the end of the intervention. Method of measurement: Movement assessment battery for children.</prim_outcome>
      <prim_outcome>Hand dexterity. Timepoint: Before the intervention and the end of the intervention. Method of measurement: Movement assessment battery for children.</prim_outcome>
      <prim_outcome>Aiming and catching. Timepoint: Before the intervention and the end of the intervention. Method of measurement: Movement assessment battery for children.</prim_outcome>
      <prim_outcome>Penalty of basketball. Timepoint: Before the intervention and the end of the intervention. Method of measurement: The result of the throwing basketball ball to the ring is calculated as 7 points.</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>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-09</approval_date>
        <contact_name>Ethics Committee on Biomedical Research in Tarbiat Modares University</contact_name>
        <contact_address>Jalal AleAhmad Blvd, Nasr bridge, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
