<?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>IRCT20240527061919N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-18</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effectiveness of tele-occupational therapy compared to face-to-face occupational therapy</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of tele-occupational therapy and face-to-face occupational therapy on improving reading in children with dyslexia in primary school</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77060</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be divided into two groups using the random block method with the help of the blokrand function in R 4.2.2 software.
It is worth noting that randomization will be done in the following arrangement: B B A A A B A B B A B A B A A B A B B B A A A B A B B B A; where B will represent placement in the test group and A will represent placement in the control group, Blinding description: The participants in the research will enter the research knowingly. A pre-test will be taken from all participants in the study to enter the study. None of the participants will know how to be placed in the groups and the type of group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dyslexia.</hc_freetext>
      <i_freetext>Intervention 1: Control group: clients with dyslexia who receive occupational therapy interventions in person. Interventions in the control group will be provided face-to-face by the therapist in 14 45-minute sessions. Before allocating people to two groups, there will be a pre-test and a post-test at the end of the interventions, and a follow-up will be done after 2 months. The first, middle and final sessions will be considered to ensure the cooperation of the families. The second to sixth sessions and the eighth to thirteenth sessions will be interventions in the field of working memory and attention and in order to improve and understand the content. Intervention 2: Intervention group: Clients with dyslexia who receive occupational therapy interventions remotely. Interventions of the experimental group will be provided in the form of video calls and providing interventions from behind the phone and explanations to parents in 14 sessions of 45 minutes. Before assigning people to two groups, a pre-test and a post-test will be taken at the end of the interventions, and a follow-up will be done after 2 months. The first, middle and final sessions will be held in person to evaluate and ensure the cooperation of the families. The second to sixth sessions and the eighth to thirteenth sessions will be interventions in the field of working memory and attention and to improve reading and comprehension.</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:
Research data. 
The data will only be made available to professors and principal researchers.

When:
The access period starts 6 months after the results are published

To whom:
The data will be in the hands of the original researchers, and after the work is completed, the results will be published in authoritative articles.

Conditions:
In case, non-identifiable data will be provided to people for research in line with the continuation of said research.

Where to obtain:
To receive the data, they can refer to Dr. Ghazaleh Mandani.
Address: Occupational Therapy Training Group., university of social welfare and rehabilitation sciences ., dead end kodakyar., daneshjo blv., velenjak., tehran
Postal code: 1985713871
Email: ghazal.mandani@gmail.com

How to obtain:
After sending the data application request, if approved by the professors, the data file will be sent. It will take at least one month from the time of sending the confirmation of the data request application to the sending of the data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeynab moravvej</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Rehabilitation Sciences and Social Health., Kodakyar dead end., Student Blvd., Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 7173 2000</telephone>
        <email>Zeynabmoravvej78@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghazale mandani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Rehabilitation Sciences and Social Health., Kodakyar dead end., Daneshjo Blvd., Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2218 0037</telephone>
        <email>ghazal.mandani@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be second, third and fourth grade
A diagnosis of special learning disorder has been mentioned by a psychiatrist
Parents must have informed consent to enter the research</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>11 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having other disorders along with learning disorder</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>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: clients with dyslexia who receive occupational therapy interventions in person. Interventions in the control group will be provided face-to-face by the therapist in 14 45-minute sessions. Before allocating people to two groups, there will be a pre-test and a post-test at the end of the interventions, and a follow-up will be done after 2 months. The first, middle and final sessions will be considered to ensure the cooperation of the families. The second to sixth sessions and the eighth to thirteenth sessions will be interventions in the field of working memory and attention and in order to improve and understand the content.</i_keyword>
      <i_keyword>Intervention group: Clients with dyslexia who receive occupational therapy interventions remotely. Interventions of the experimental group will be provided in the form of video calls and providing interventions from behind the phone and explanations to parents in 14 sessions of 45 minutes. Before assigning people to two groups, a pre-test and a post-test will be taken at the end of the interventions, and a follow-up will be done after 2 months. The first, middle and final sessions will be held in person to evaluate and ensure the cooperation of the families. The second to sixth sessions and the eighth to thirteenth sessions will be interventions in the field of working memory and attention and to improve reading and comprehension.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Working memory. Timepoint: The first, middle and final session of the research. Method of measurement: Cantab test sub-test of spatial working memory.</prim_outcome>
      <prim_outcome>Attention. Timepoint: The first, middle and final session of the research. Method of measurement: Cantab test sub-test of intra-dimensional/extra-dimensional shift.</prim_outcome>
      <prim_outcome>Comprehension. Timepoint: The first, middle and final session of the research. Method of measurement: reading and dyslexia 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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-09-28</approval_date>
        <contact_name>Ethics committee of Social Welfare and Rehabilitation Sciences university</contact_name>
        <contact_address>University of Rehabilitation Sciences and Social Health., Kodakyar dead end., Student Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
