<?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>IRCT20241227064180N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-06</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of occupational therapy interventions using transparent 3D digital pegboard on the visual perception skills of children</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of occupational therapy interventions using transparent 3D digital pegboard on the visual perception skills of children with specific learning disorder 7 to 12 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81383</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization
To do this, we use a table of random numbers. After determining the population frame, we assign a code to each individual in the population;(In concealment, each person's name or code is placed in numbered envelopes) then, using the table, we determine the control or intervention group, Blinding description: Since blinding is double-blind (evaluator and statistical analyst):
The evaluator/assessor will not be aware of which group the participants belong to during the evaluation;
The analyst will only have the data and will not receive information about the intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Learning Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Control Group، Interventions are implemented based on a 20-session treatment protocol that was prepared under the supervision of professors at the Faculty of Rehabilitation at the University of Iran and reviewed by a panel of experts.                                 Interventions for the intervention group will be implemented individually for 10 weeks, 2 sessions per week, and each session will last half an hour to 45 minutes. It should be noted that routine treatment and special training of the centers will continue for both groups. After the completion of the interventions, the post-test will be re-administered by the two aforementioned tests (by the first blind assessor). The results obtained from the two evaluation stages will be statistically analyzed and a follow-up will be conducted for both groups one month later.In the treatment plan written in the protocol, each of the subtests of the Test of Visual Perception Skills (TVPS) is the target of two to three treatment sessions. Note: The transparent 3D digital pegboard was patented with number 109288 on 1402/03/02; it is expected that visual perception skills such as visual discrimination, visual memory, spatial relationships, shape stability, visual sequencing, shape recognition from the background, visual completion, and specifically depth perception skills, 3D vision can be strengthened and improved through this pegboard. Intervention 2: Intervention group: The intervention group will be implemented based on a 20-session treatment protocol prepared under the supervision of professors of the Faculty of Rehabilitation of the University of Iran and reviewed by a panel of experts. The interventions will be implemented individually for 10 weeks, 2 sessions per week, and each session will last half an hour to 45 minutes. After the interventions are completed, the post-test will be re-administered using the two aforementioned tests (by the first blind evaluator). The results obtained from the two evaluation stages will be statistically analyzed, and a follow-up will be conducted for both groups one month later. In the treatment plan written in the protocol, each of the subtests of the visual perception skills test aims for two to three treatment sessions. According to the existing levels and the division of sessions, the first and second sessions focus on visual discrimination, the third and fourth sessions on form constancy, the fifth and sixth sessions on figure ground discrimination, the seventh to ninth sessions on spatial relations, the tenth to twelfth sessions on visual closure, the thirteenth to fifteenth sessions on sequential memory, the sixteenth to eighteenth sessions on visual memory, and the last two sessions on reviewing and proving what has been learned. An executive instruction is written for each session, and movement exercises are also included during the intervention to prevent the child from getting tired.All of the above goals are expected to be achieved by working with a digital pegboard.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Perdam Shahebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.8, First Floor, First Staircase, Block 13, Abadani &amp; Maskan Complex, Abu Reihan Cross Roads, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5174633948</zip>
        <telephone>+98 41 3477 0074</telephone>
        <email>p.shahebrahimi@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elahe Hojati Abed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran Street, Shah Nazari Street, Madar Square, Mirdamad, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷ ۱۵۴۵۹</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>Elahe_hojati@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 7 to 12 years
Being Iranian and understanding the Persian language by the participants
Parental consent
Diagnosis of a learning disorder by a pediatrician or psychiatrist
Ability to understand instructions, repeated explanation up to 3 times</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Problems with amblyopia and diplopia using the records available in the centers
Absence of more than 3 consecutive sessions
Any major life event or occurrence that prevents cooperation/participation in the research.
Neurological disorder, especially seizures or active seizures in the past 6 months
Motor problems in the upper limbs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F81.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Developmental disorder of scholastic skills, unspecified</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: Control Group، Interventions are implemented based on a 20-session treatment protocol that was prepared under the supervision of professors at the Faculty of Rehabilitation at the University of Iran and reviewed by a panel of experts.                                 Interventions for the intervention group will be implemented individually for 10 weeks, 2 sessions per week, and each session will last half an hour to 45 minutes. It should be noted that routine treatment and special training of the centers will continue for both groups. After the completion of the interventions, the post-test will be re-administered by the two aforementioned tests (by the first blind assessor). The results obtained from the two evaluation stages will be statistically analyzed and a follow-up will be conducted for both groups one month later.In the treatment plan written in the protocol, each of the subtests of the Test of Visual Perception Skills (TVPS) is the target of two to three treatment sessions. Note: The transparent 3D digital pegboard was patented with number 109288 on 1402/03/02; it is expected that visual perception skills such as visual discrimination, visual memory, spatial relationships, shape stability, visual sequencing, shape recognition from the background, visual completion, and specifically depth perception skills, 3D vision can be strengthened and improved through this pegboard.</i_keyword>
      <i_keyword>Intervention group: The intervention group will be implemented based on a 20-session treatment protocol prepared under the supervision of professors of the Faculty of Rehabilitation of the University of Iran and reviewed by a panel of experts. The interventions will be implemented individually for 10 weeks, 2 sessions per week, and each session will last half an hour to 45 minutes. After the interventions are completed, the post-test will be re-administered using the two aforementioned tests (by the first blind evaluator). The results obtained from the two evaluation stages will be statistically analyzed, and a follow-up will be conducted for both groups one month later. In the treatment plan written in the protocol, each of the subtests of the visual perception skills test aims for two to three treatment sessions. According to the existing levels and the division of sessions, the first and second sessions focus on visual discrimination, the third and fourth sessions on form constancy, the fifth and sixth sessions on figure ground discrimination, the seventh to ninth sessions on spatial relations, the tenth to twelfth sessions on visual closure, the thirteenth to fifteenth sessions on sequential memory, the sixteenth to eighteenth sessions on visual memory, and the last two sessions on reviewing and proving what has been learned. An executive instruction is written for each session, and movement exercises are also included during the intervention to prevent the child from getting tired.All of the above goals are expected to be achieved by working with a digital pegboard.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual perception skill score in the Visual perception skills-Revised test. Timepoint: Assessment of visual perception skills before intervention, after intervention (end of week 10), one month after the end of the intervention. Method of measurement: Using the Visual Perception Skills-Revised Test.</prim_outcome>
      <prim_outcome>3D vision skill score in the Stereo Fly Test. Timepoint: Assessment of 3D vision skills before intervention, after intervention (end of week 10), one month after the end of the intervention. Method of measurement: Using the Stereo Fly Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Academic performance score. Timepoint: Assessment of academic performance before intervention, after intervention (end of week 10), one month after the end of the intervention. Method of measurement: Using academic transcripts.</sec_outcome>
      <sec_outcome>Academic performance score. Timepoint: Assessment of academic performance before intervention, after intervention (end of week 10), one month after the end of the intervention. Method of measurement: Using Advanced Progressive Matrices 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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-21</approval_date>
        <contact_name>Research ethics committees of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
