<?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>IRCT20160726029086N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-21</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of visualization exercises on visual motor perception and stereotyped behaviors in autism</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Effect of Motor Imagery Training on Perception Visual-Motor and Stereotypical Behaviors of Children with Autism Spectrum Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70890</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects were randomly divided into two experimental and control groups (15 people in each group) through drawing a number.</study_design>
      <phase>2-3</phase>
      <hc_freetext>autism.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After the careful selection and grouping of subjects, movement imaging exercises according to the standard and valid protocol of Wilson et al. are presented for the 6-step intervention group. 1: Visualization according to the timing; in this step, the task of tracking a disc in different colors and speeds is presented so that the child can follow the discs with his eyes based on the timing. (10 minutes). 2: relaxation and mental preparation; at this stage, the child is talked to and by playing some cooperative games, he is mentally ready to start the main effort of mental exercises. (5 minutes). Third: Modeling of basic movement skills; pattern of skillful implementation of basic movement skills of walking, running, jumping in pairs, rolling, trotting, running hiccups, throwing and receiving, dodging, placing parts on the screen, which are edited as 3D videos and in order to accurately control the presentation of the exercises, are provided to each participant individually by means of a high quality Polaroid glasses. (10 minutes). Fourth: mental practice of skills from an external perspective; The execution of the skill of an identical child (third person) is shown in the form of a video, and then he is asked to visualize the skill and review it mentally. (10 minutes). Fifth: mental practice of the skill from an internal point of view; performing the skill in such a way that the person himself is performing the movement (first person) is shown in the form of a video, and then he is asked to visualize the skill and review it mentally. (10 minutes). Sixth: real performance of the skill along with mental practice; A real performance of each skill is performed by the child, and after each performance, he is asked to visualize the skill and perform it again so that the skill is mentally reviewed and accurately visualized. (5 minutes). The total of all steps is 60 minutes (1 hour). Also, in the implementation of perceptual interventions, each intervention is measured in a dark room where the only light in the environment is the light of the monitor. Each participant sits on a chair with a distance of 60 cm from the monitor screen. in such a way that he is completely leaning on the seat support and can easily see the monitor screen in front of him. Children were asked to keep their head still while responding to the attempts of two perceptual interventions. But there is no specific restriction on head movement. At the end of recording the interventions, the children's cooperation is appreciated in some way. Intervention 2: For the control group, ongoing and routine treatments (usual rehabilitation programs that include occupational therapy, speech therapy, and behavioral therapy) are performed. For both groups, exercises are done three times a week.</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 Because the data has not been completed yet and the supervisor must give permission to give it to others.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Alsadat Kardani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.2;  Marzdaran; Jalal Al-e-Ahmad street; 3rd street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1463445799</zip>
        <telephone>+98 21 4437 8406</telephone>
        <email>kardaani.maryam@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Alsadat Kardani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.2; Marzdaran; Jalal Al-e-Ahmad street; 3rd street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1462345465</zip>
        <telephone>+98 21 4437 8406</telephone>
        <email>kardaani.maryam@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The main and dominant diagnosis of autism spectrum disorder, grade 1 and 2
Consent of children and parents to participate in therapy sessions
Age range from 5 to 12 years</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any other concurrent disorder other than autism that can be considered as the main diagnosis.
Existence of physical diseases
Receiving effective treatments on motion imaging therapy in other centers
Having any structural or functional problems in the vision system, approved by a specialist doctor
Previous experience of receiving movement imaging exercises</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: After the careful selection and grouping of subjects, movement imaging exercises according to the standard and valid protocol of Wilson et al. are presented for the 6-step intervention group. 1: Visualization according to the timing; in this step, the task of tracking a disc in different colors and speeds is presented so that the child can follow the discs with his eyes based on the timing. (10 minutes). 2: relaxation and mental preparation; at this stage, the child is talked to and by playing some cooperative games, he is mentally ready to start the main effort of mental exercises. (5 minutes). Third: Modeling of basic movement skills; pattern of skillful implementation of basic movement skills of walking, running, jumping in pairs, rolling, trotting, running hiccups, throwing and receiving, dodging, placing parts on the screen, which are edited as 3D videos and in order to accurately control the presentation of the exercises, are provided to each participant individually by means of a high quality Polaroid glasses. (10 minutes). Fourth: mental practice of skills from an external perspective; The execution of the skill of an identical child (third person) is shown in the form of a video, and then he is asked to visualize the skill and review it mentally. (10 minutes). Fifth: mental practice of the skill from an internal point of view; performing the skill in such a way that the person himself is performing the movement (first person) is shown in the form of a video, and then he is asked to visualize the skill and review it mentally. (10 minutes). Sixth: real performance of the skill along with mental practice; A real performance of each skill is performed by the child, and after each performance, he is asked to visualize the skill and perform it again so that the skill is mentally reviewed and accurately visualized. (5 minutes). The total of all steps is 60 minutes (1 hour). Also, in the implementation of perceptual interventions, each intervention is measured in a dark room where the only light in the environment is the light of the monitor. Each participant sits on a chair with a distance of 60 cm from the monitor screen. in such a way that he is completely leaning on the seat support and can easily see the monitor screen in front of him. Children were asked to keep their head still while responding to the attempts of two perceptual interventions. But there is no specific restriction on head movement. At the end of recording the interventions, the children's cooperation is appreciated in some way.</i_keyword>
      <i_keyword>For the control group, ongoing and routine treatments (usual rehabilitation programs that include occupational therapy, speech therapy, and behavioral therapy) are performed. For both groups, exercises are done three times a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stereotyped behaviors. Timepoint: Before and after the intervention and one-month follow-up. Method of measurement: Gliam-Garz autism rating scale.</prim_outcome>
      <prim_outcome>Visual-motor perception. Timepoint: Before and after the intervention and one-month follow-up. Method of measurement: Frostic test.</prim_outcome>
      <prim_outcome>Power of Motion visualization. Timepoint: Before and after the intervention and one-month follow-up. Method of measurement: motor imagery questionnaire.</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 (no financial support)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-17</approval_date>
        <contact_name>Ethics committee of Tehran Islamic Azad University</contact_name>
        <contact_address>No. 5, corner of Ram street, Nistan 9th, Pasdaran street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
