<?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>IRCT20191112045425N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-27</date_registration>
      <primary_sponsor>Hakim Sabzevar University</primary_sponsor>
      <public_title>The effect of eye exercises  on  children with amblyopia</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eye exercises with and without active movements on motor skills in children with amblyopia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43624</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Subjects were randomly assigned to one of four groups by simple random method (ball and bowl). The groups were randomly assigned to experimental and control groups, Blinding description: Attendees at different times to intervene
Supplementary Description: Before the subjects were included in the study, a general introduction to the research objectives for the subject and their parents was made. So they knew the whole point. Subjects were present at the training site at different times to observe the “independence of observations”.
Using an evaluator that was not part of the research group
Use statistics expert.</study_design>
      <phase>N/A</phase>
      <hc_freetext>amblyopia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First. Exercise-Free Vision Training Group (Exercise Vision-Free Bodybuilding). The subjects in this group sat in a stationary and immobilized position and performed dynamic sharpening exercises, field-based perception, depth-perception, and eye-tracking using movement only. The eyes did. Subjects performed three 30-minute sessions of exercise for four weeks each week. Intervention 2: Intervention group: Second. The group with active low vision exercises consisted of hands-on visual exercises (visual-manual exercises). Field perception, depth perception, and visual pursuit were performed with hand movement. Subjects performed three 30-minute sessions of exercise for four weeks each week. Intervention 3: Intervention group: Third. High-intensity, active-motion visual exercises that included whole-body visual training (visual-movement exercises). Subjects performed visual-displacement exercises, dynamic sharpening exercises, field form perception, depth perception, and visual pursuit along with whole-body displacement. Subjects performed three 30-minute sessions of exercise for four weeks each week. Intervention 4: Control group: The control group subjects did their daily activities and did not perform any extra exercises. Only participated in pre-test and post-test.</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:
Motor skills scores can be shared.

When:
Start of access period 6 months after printing results

To whom:
participants

Conditions:
Data and documentation are available for use in welfare centers.

Where to obtain:
Apply to mr.shahabi@hsu.ac.ir

How to obtain:
Results will be announced a week after the application is submitted

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Reza Shahabi Kaseb</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of Hakim University of Sabzevari, Tohid Shahr, Sabzevar, Khorasan Razavi</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617976487</zip>
        <telephone>+98 51 4441 4160</telephone>
        <email>mr.shahabi@hsu.ac.ir</email>
        <affiliation>Hakim Sabzevari University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Shahabi Kaseb</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of Hakim University of Sabzevari, Tohid Shahr, Sabzevar, Khorasan Razavi</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617976487</zip>
        <telephone>+98 51 4441 4160</telephone>
        <email>mr.shahabi@hsu.ac.ir</email>
        <affiliation>Hakim Sabzevar University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with amblyopia (caused by refractive errors)</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>8 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H00-H59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the eye and adnexa</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First. Exercise-Free Vision Training Group (Exercise Vision-Free Bodybuilding). The subjects in this group sat in a stationary and immobilized position and performed dynamic sharpening exercises, field-based perception, depth-perception, and eye-tracking using movement only. The eyes did. Subjects performed three 30-minute sessions of exercise for four weeks each week.</i_keyword>
      <i_keyword>Intervention group: Second. The group with active low vision exercises consisted of hands-on visual exercises (visual-manual exercises). Field perception, depth perception, and visual pursuit were performed with hand movement. Subjects performed three 30-minute sessions of exercise for four weeks each week.</i_keyword>
      <i_keyword>Intervention group: Third. High-intensity, active-motion visual exercises that included whole-body visual training (visual-movement exercises). Subjects performed visual-displacement exercises, dynamic sharpening exercises, field form perception, depth perception, and visual pursuit along with whole-body displacement. Subjects performed three 30-minute sessions of exercise for four weeks each week.</i_keyword>
      <i_keyword>Control group: The control group subjects did their daily activities and did not perform any extra exercises. Only participated in pre-test and post-test</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motor Skills. Timepoint: Before the intervention and two days after the last training session (after the intervention). Method of measurement: Lincoln Oseretsky's test.</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>Hakim Sabzevar University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-05</approval_date>
        <contact_name>Ethics committee of Islamic Azad University of Sabzevar</contact_name>
        <contact_address>خراسان رضوی ، سبزوار ، توحید شهر، پردیس دانشگاه حکیم سبزواری Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
