<?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>IRCT20181222042071N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-02</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of active video games on cognitive and motor skills in children with developmental coordination disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the impact of traditional occupational therapy and commercially available active video games on improving motor skills and sustained attention and response times in children with developmental coordination disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36168</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, the subjects will be randomly assigned to two groups of intervention and control using card shuffling method. In this way, 20 cards are designed from 1 to 20, and after merging (shuffling), a card is given to each subject, and then the subjects whose number are even will be placed in the intervention group and those who have odd number will be placed in the control group, Blinding description: None of the participation's will be aware of the existence of the other group and the examiner  wont be aware of intervention groups members.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Developmental Coordination Disorder according to the DSM 5.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In this group,  active video games will  play for 9 weeks, each week with three 45-minute sessions, under the supervision of therapist. The therapist will try to maintain the child's attention to the process of play, the rules of the game will be communicated to the child by the therapist, all the wrong movements of the child will be corrected and his movements will be encouraged and strengthened. Intervention 2: Control group: In the group of traditional occupational therapy interventions for 9 weeks each week, three 45-minute sessions will be conducted with emphasis on sensory and perceptual integrity approaches by trained occupational therapists. In these sessions, exercises will be aimed at sensory modification, deepening sense, exercise planning exercises, balancing exercises, strengthening subtle movements and enhancing visual and hearing perception. The treatment plan will be based on the assessment results and will be programmed for each child individually.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mona Siminglalam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan University of Madical Sciences, Basij Blvd., Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>siminghalam@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mona Siminghalam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Semnan University of Madical Sciences, Basij Blvd., Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4180</telephone>
        <email>siminghalam@semums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with developmental coordination disorder
Typical  IQ
Age range from 6 to 9</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>9 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children with attention deficit hyperactivity disorder
Children with Seizure
Children with Visual acuity problems that can not be corrected with glasses
Children with orthopedic disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Specific developmental disorder of motor function</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 this group,  active video games will  play for 9 weeks, each week with three 45-minute sessions, under the supervision of therapist. The therapist will try to maintain the child's attention to the process of play, the rules of the game will be communicated to the child by the therapist, all the wrong movements of the child will be corrected and his movements will be encouraged and strengthened.</i_keyword>
      <i_keyword>Control group: In the group of traditional occupational therapy interventions for 9 weeks each week, three 45-minute sessions will be conducted with emphasis on sensory and perceptual integrity approaches by trained occupational therapists. In these sessions, exercises will be aimed at sensory modification, deepening sense, exercise planning exercises, balancing exercises, strengthening subtle movements and enhancing visual and hearing perception. The treatment plan will be based on the assessment results and will be programmed for each child individually.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The motor skills score of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition. Timepoint: At the beginning of study and after 9 weeks traditional  occupational therapy and active video game intervention. Method of measurement: Bruininks-Oseretsky Test of Motor Proficiency, Second Edition.</prim_outcome>
      <prim_outcome>The continues performance score of Continues Performance Test. Timepoint: At the beginning of study and 9 week safter intervention. Method of measurement: Continuous Performance test (CPT).</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-15</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan University of Medical Sciences, Basij Blvd., Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
