<?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>IRCT20210925052568N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-16</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Study the effect of online visual games on balance, visual perception and, oculomotor skills of children with developmental dyslexia</public_title>
      <acronym></acronym>
      <scientific_title>Study the effect of online visual games on balance, visual perception, and oculomotor skills of children with developmental dyslexia during Covid -19 pandemic</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58921</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is the random allocation rule. This method represents a large block for the total sample size, which is 50 people, which randomly assigns 25 children with developmental dyslexia (DD) in the intervention group and the rest of the children with DD are in the control group. The number is assigned and the numbers are written on paper and packaged in exactly the same way. These numbers are placed in a container and then the numbers are randomly removed from the container without replacement and the created sequence is recorded. The first 25 children are in the intervention group and the rest are in the control group, Blinding description: Evaluators including a psychologist, an occupational therapist, and an audiologist.
They perform all assessments, including TVPS-R, PBS, VNG, Wechsler Child Scale (WISC-IV), and reading and dyslexia (NMA) tests.
Evaluators will not be aware of whether individuals are in the control or intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>developmental dyslexia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The interventions will be performed in 15 sessions on a daily basis for a month and for 30 minutes a day. The interventions will be designed and made by Niloufar Chamani (Master student of Occupational Therapy) in the form of computer games and will be provided to the intervention group in the form of online computer games for one month. Computer games will be designed and made using visual perception training cards and eye movement exercises. Intervention 2: Control group: Does not receive any intervention in this study.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloufar Chamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 2, no 3, Haghighat alley, Aram st, Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6515759966</zip>
        <telephone>+98 81 3822 4030</telephone>
        <email>n.chamani72@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Niloufar Chamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 2, no 3, Haghighat alley, Aram st, Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6515759966</zip>
        <telephone>+98 81 3822 4030</telephone>
        <email>n.chamani72@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The diagnosis of Developmental dyslexia
NEMA scores are lower than average
Have a normal IQ (equal to or above 85)
Age between 7 and 11 years (first grader must be at least in the second quarter of the school year)
Fluency in Persian</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>11 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of any neurological disorder, attention deficit hyperactivity disorder or visual sensory impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R48.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dyslexia and alexia</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 interventions will be performed in 15 sessions on a daily basis for a month and for 30 minutes a day. The interventions will be designed and made by Niloufar Chamani (Master student of Occupational Therapy) in the form of computer games and will be provided to the intervention group in the form of online computer games for one month. Computer games will be designed and made using visual perception training cards and eye movement exercises.</i_keyword>
      <i_keyword>Control group: Does not receive any intervention in this study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual perception skills. Timepoint: At the beginning of the study and at the end of the study. Method of measurement: Test of Visual Perception Skills-Revised.</prim_outcome>
      <prim_outcome>Oculomotor skills. Timepoint: At the beginning of the study and at the end of the study. Method of measurement: Videonystagmography.</prim_outcome>
      <prim_outcome>Postural balance skills. Timepoint: At the beginning of the study and at the end of the study. Method of measurement: Pediatric Balance Scale.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-04</approval_date>
        <contact_name>Research Ethics committees of school of Nursing and Midwifery &amp; Rehabilitation - Tehran University o</contact_name>
        <contact_address>Unit 2, no 3, Haghighat alley, Aram st, Hamedan Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
