<?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>IRCT2017041412053N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-11</date_registration>
      <primary_sponsor>Iran University of Medical Sciences, Knowledge and Translation and Exchange Unit</primary_sponsor>
      <public_title>Impact of perceptual- motor package use on learning disorder in children</public_title>
      <acronym></acronym>
      <scientific_title>Impact of perceptual- motor package use on learning disorder in children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12194</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>learning disorder.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group receives package and practices tasks 3 times in a week for 3 consecutive months and is evaluated by pretest and posttest. This educational package consists of 6 parts and every part lasts 10 minutes. It has been made by occupational therapist and resident of psychiatry after getting a consent form of a child and her parents and the exercises will be recorded in 6 weekly sessions. After making the film and organizing the material, the study is started. Following domains have been considered in this package: 1. Ocular exercises include 3 types of eye movement: staring, pursuing and saccadic movement like exercise with flashlight or finding the direction. Visual perception exercises include increasing visual memory, discrimination and closure like tapping. 2. Motor planning exercises include coordination between limbs and simultaneous use of several organs (hands, feet and eyes) like imitation of postures. 3. Memory exercises in 2 forms: phonological (repeating several words) and visual- perceptual (playing with Lego or jigsaw). 4. Some exercises for auditory discrimination to separate sounds and to find the source of sound. 5. Some exercises for persistent, selective and alternative attention that increases child’s tolerance. 6. Some exercises for problem solving and reasoning to involve in academic activities and to find solution by deductive or inductive ways like playing with numbers. Intervention 2: The second group practices the same tasks (like educational package) by helping an occupational therapist in the clinic. They get exercises in 3 weekly sessions for 3 consecutive months. They are evaluated by pretest and posttest. Intervention 3: The Third group is the control group who just participated in pretest and posttest. They are selected from waiting list of clinic who have learning disorder and they have signed the consent form after getting explanation about the research.&#13;
 Follow up is done by calling parents weekly, asking about educational package. If they do not answer the call, it would be repeated.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mostafa Khomeini Street, Shahid Yayanejad Hospital</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4713655647</zip>
        <telephone>+98 11 3222 5035</telephone>
        <email>hsalehi_2003@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Scineces</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Hakim Shooshatri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahied Mansuri St., Niayesh St., Sattarkhan Ave., Tehran , I.R. Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1447673173</zip>
        <telephone>+98 21 2222 6127</telephone>
        <email>mitra.hakim@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: grade 1 to grade 4 students; having learning disorder based on a child psychiatrist diagnosis&#13;
exclusion criteria: history of seizure; history of other neurological or orthopedic problems; having autism</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F81.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>specific reading disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group receives package and practices tasks 3 times in a week for 3 consecutive months and is evaluated by pretest and posttest. This educational package consists of 6 parts and every part lasts 10 minutes. It has been made by occupational therapist and resident of psychiatry after getting a consent form of a child and her parents and the exercises will be recorded in 6 weekly sessions. After making the film and organizing the material, the study is started. Following domains have been considered in this package: 1. Ocular exercises include 3 types of eye movement: staring, pursuing and saccadic movement like exercise with flashlight or finding the direction. Visual perception exercises include increasing visual memory, discrimination and closure like tapping. 2. Motor planning exercises include coordination between limbs and simultaneous use of several organs (hands, feet and eyes) like imitation of postures. 3. Memory exercises in 2 forms: phonological (repeating several words) and visual- perceptual (playing with Lego or jigsaw). 4. Some exercises for auditory discrimination to separate sounds and to find the source of sound. 5. Some exercises for persistent, selective and alternative attention that increases child’s tolerance. 6. Some exercises for problem solving and reasoning to involve in academic activities and to find solution by deductive or inductive ways like playing with numbers.</i_keyword>
      <i_keyword>The second group practices the same tasks (like educational package) by helping an occupational therapist in the clinic. They get exercises in 3 weekly sessions for 3 consecutive months. They are evaluated by pretest and posttest.</i_keyword>
      <i_keyword>The Third group is the control group who just participated in pretest and posttest. They are selected from waiting list of clinic who have learning disorder and they have signed the consent form after getting explanation about the research.&#13;
 Follow up is done by calling parents weekly, asking about educational package. If they do not answer the call, it would be repeated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reading ability and working memory. Timepoint: Preintervention. Method of measurement: Screening Inventory Reading Test (IRT) and  N-Back Working Memory Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Earning ability and working memory. Timepoint: After 3 months intervention. Method of measurement: Screening Inventory Reading Test (IRT) and  N-Back Working Memory Test.</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>Iran University of Medical Sciences, Knowledge and Translation and Exchange Unit</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-06</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat Highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
