<?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>IRCT20180521039770N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-25</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of  Tele occupational therapy interventions on educational performance of students with  learning disorder</public_title>
      <acronym></acronym>
      <scientific_title>Designing and evaluating the effect of school-based occupational therapy interventions via tele-rehabilitation method on education in students with specific learning disorder aged 8 to 12 years old based on the Canadian Model of Occupational Performance</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61255</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: After agreeing to participate in the study and signing the consent form, participants will be divided into two intervention groups and a control group by a simple accident distribution method by someone other than the researcher, evaluator and intervener. The dice roll method will be used to perform a simple random distribution. The numbers 1 and 2 will be considered for the intervention group by remote rehabilitation method, the numbers 3 and 4 will be considered for the intervention group by the clinic method and the numbers 5 and 6 will be considered for the control group and individuals will be randomly assigned to three groups. They find. The central randomization method will be used to conceal random allocation. In this method, a random sequence is provided to a specific center and the researcher communicates with the relevant center based on the order in which the participants enter the study and asks about the random assignment of the participant to a specific group. Communication methods include the use of telephone and SMS, Blinding description: In this study, both participants and outcome assessors are unaware of the allocation of study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Specific learning disorder. Condition 2: Specific learning disorder. Condition 3: Specific learning disorder.</hc_freetext>
      <i_freetext>Intervention 1: The Canadian Model of Occupational Performance (CMOP) is one of the occupational therapy models. According to this model, occupation is the result of dynamic interaction between the person and the environment, and each has different components. In this model, the occupation includes three domains: self-care, productivity and leisure, the person includes three main components: affective, physical, and cognitive abilities, and the environment including physical, social, cultural, and institutional environment of the client. This model is used in clinical setting by a tool called the Canadian Occupational Performance Measure (COPM). This tool is a semi-structured interview in which the clients determine their therapeutic goals in the field of occupational performance and give them points in terms of priority and satisfaction. The therapist designs treatment goals based on set priorities and provides appropriate treatments to each client based on evaluations. In this study, in both intervention groups, this method is used to determine the therapeutic interventions of each student and only the method of providing interventions is different in the two groups (one intervention group received the method of tele-rehabilitation and other intervention group received the in-person method). Intervention 2: Intervention group 2: Intervention group by attending the clinic: The interventions of this group will be performed by a trained occupational therapist with at least 2 years of experience in the field of learning disabilities. This person is completely blind to reading. All intervention protocols in the intervention group will be presented to this group by remote rehabilitation method, with the difference that in this group, all evaluation and intervention steps will be performed in person. Intervention 3: Control group: This group will receive common interventions in education and rehabilitation centers for special learning problems. Students with learning disorders are referred to these centers by the school. In these centers, the student is first evaluated with Wechsler Intelligence Scale for Children (WISC) and is accepted if the learning disorder is confirmed. After that, he attends individual classes for one or two days a week for one hour. In this session, a teacher evaluates the student's performance in reading, writing, math, and science based on his / her educational grade, and according to the results of his / her observations and evaluation, teaches lessons in which the child's performance will be poor. Sometimes, if necessary, lessons related to previous grades are also taught. Worksheets for repeating and practicing the taught items will also be provided as homework.</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:
Some of the data can be shared after unidentifiable individuals such as age, gender and educational grade, as well as data related to the main outcome of the research.

When:
It is possible to start accessing the results 6 months after the outcomes are published in the form of an article.

To whom:
Researchers working in academic and scientific institutions, people working in educational center , decision makers in the field of health management

Conditions:
Researchers working in academic and scientific institutions, people working in educational center and decision makers in the field of health management can send their request for access to data by sending an email to the person is responsible for scientific response (principal researcher). Performing statistical analyzes different from the main research to extract other consequences is permitted by obtaining permission from the researcher and the supporting organization (Vice Chancellor for Research and Technology of Iran University of Medical Sciences).

Where to obtain:
1- Main researcher: Dr. Mehdi Alizadeh Zarei
Email: alizadeh.m@iums.ac.ir
Phone: Phone: 00982122222059 Internal: 333
Address: School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.
2- Vice Chancellor for Research and Technology of Iran University of Medical Sciences
Email: research-m@iums.ac.ir
Tel: 00982186702503-00982186702504
Address: 
Iran University of Medical Sciences, Shahid Hemmat Highway,
Tehran, 1449614535, IRAN

How to obtain:
Applicants should send their request by sending email to the main researcher Dr. Mehdi Alizadeh Zarei or the Vice Chancellor for Research and Technology of Iran University of Medical Sciences. They can also refer to the address of the occupational therapy department of the Faculty of Rehabilitation sciences of Iran University of Medical Sciences or the Vice Chancellor for Research and Technology of Iran University of Medical Sciences and submit their written request. After reviewing the request, if the permission to access the data and documents is possible, it will be issued and provided to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Kheirollahzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shah Nazari St., Mother Square, Mirdamad Blvd, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷ - ۱۵۴۵۹</zip>
        <telephone>009822222059</telephone>
        <email>kheyrollahzade.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Alizadeh Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shah Nazari St., Mother Square, Mirdamad Blvd, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷ - ۱۵۴۵۹</zip>
        <telephone>009822222059</telephone>
        <email>alizadeh.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 8 to 12 years for both girls and boys
Definitive diagnosis of a specific learning disorder by a psychiatrist or learning disorder experts
Living in the city of Tehran
Internet access; Home or mobile internet with a minimum speed of 128 kbps
Access to smartphones, or personal computers, or laptops or tablets
At least a diploma and basic computer literacy for a parent who is going to work with the research team in therapy sessions.</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of irreparable physical, visual and hearing problems with assistive devices
Comorbidity of psychiatric disorders based on the contents of the student's medical and educational records.
Refusal to sign informed consent by parents</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F81.0</hc_code>
      <hc_code>F81.81</hc_code>
      <hc_code>F81.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Specific reading disorder</hc_keyword>
      <hc_keyword>Disorder of written expression</hc_keyword>
      <hc_keyword>Mathematics disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The Canadian Model of Occupational Performance (CMOP) is one of the occupational therapy models. According to this model, occupation is the result of dynamic interaction between the person and the environment, and each has different components. In this model, the occupation includes three domains: self-care, productivity and leisure, the person includes three main components: affective, physical, and cognitive abilities, and the environment including physical, social, cultural, and institutional environment of the client. This model is used in clinical setting by a tool called the Canadian Occupational Performance Measure (COPM). This tool is a semi-structured interview in which the clients determine their therapeutic goals in the field of occupational performance and give them points in terms of priority and satisfaction. The therapist designs treatment goals based on set priorities and provides appropriate treatments to each client based on evaluations. In this study, in both intervention groups, this method is used to determine the therapeutic interventions of each student and only the method of providing interventions is different in the two groups (one intervention group received the method of tele-rehabilitation and other intervention group received the in-person method).</i_keyword>
      <i_keyword>Intervention group 2: Intervention group by attending the clinic: The interventions of this group will be performed by a trained occupational therapist with at least 2 years of experience in the field of learning disabilities. This person is completely blind to reading. All intervention protocols in the intervention group will be presented to this group by remote rehabilitation method, with the difference that in this group, all evaluation and intervention steps will be performed in person.</i_keyword>
      <i_keyword>Control group: This group will receive common interventions in education and rehabilitation centers for special learning problems. Students with learning disorders are referred to these centers by the school. In these centers, the student is first evaluated with Wechsler Intelligence Scale for Children (WISC) and is accepted if the learning disorder is confirmed. After that, he attends individual classes for one or two days a week for one hour. In this session, a teacher evaluates the student's performance in reading, writing, math, and science based on his / her educational grade, and according to the results of his / her observations and evaluation, teaches lessons in which the child's performance will be poor. Sometimes, if necessary, lessons related to previous grades are also taught. Worksheets for repeating and practicing the taught items will also be provided as homework.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Academic school function. Timepoint: Before the start of the 12 intervention sessions, after the end of the 12 intervention sessions, one month after the end of the 12 intervention sessions. Method of measurement: Student assessment of academic self conception.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Academic school function. Timepoint: Before the start of the 12 intervention sessions, after the end of the 12 intervention sessions, one month after the end of the 12 intervention sessions. Method of measurement: Academic adequacy lists of the Ministry of Education.</sec_outcome>
      <sec_outcome>Non academic school function: physical activity performance. Timepoint: Before the start of the 12 intervention sessions, after the end of the 12 intervention sessions, one month after the end of the 12 intervention sessions. Method of measurement: school function assessment.</sec_outcome>
      <sec_outcome>Non academic school function: hand writing. Timepoint: Before the start of the 12 intervention sessions, after the end of the 12 intervention sessions, one month after the end of the 12 intervention sessions. Method of measurement: Persian handwriting assessment tool.</sec_outcome>
      <sec_outcome>Non academic school function: upper limb motor function. Timepoint: Before the start of the 12 intervention sessions, after the end of the 12 intervention sessions, one month after the end of the 12 intervention sessions. Method of measurement: Bruininks-Oseretsky Test of Motor Proficiency.</sec_outcome>
      <sec_outcome>Non academic school function: cognitive activity performance. Timepoint: Before the start of the 12 intervention sessions, after the end of the 12 intervention sessions, one month after the end of the 12 intervention sessions. Method of measurement: school function assessment.</sec_outcome>
      <sec_outcome>Non academic school function: visual perception. Timepoint: Before the start of the 12 intervention sessions, after the end of the 12 intervention sessions, one month after the end of the 12 intervention sessions. Method of measurement: test of visual perceptual skills.</sec_outcome>
      <sec_outcome>Non academic school function: working memory. Timepoint: Before the start of the 12 intervention sessions, after the end of the 12 intervention sessions, one month after the end of the 12 intervention sessions. Method of measurement: N-back test.</sec_outcome>
      <sec_outcome>Non academic school function: visual auditory integration. Timepoint: Before the start of the 12 intervention sessions, after the end of the 12 intervention sessions, one month after the end of the 12 intervention sessions. Method of measurement: integrated Visual and Auditory (IVA) Test.</sec_outcome>
      <sec_outcome>The quality and satisfaction of occupational performance in the priorities set by the parents. Timepoint: Before the start of the 12 intervention sessions, after the end of the 12 intervention sessions, one month after the end of the 12 intervention sessions. Method of measurement: Canadian occupational performance measure.</sec_outcome>
      <sec_outcome>Student assessment of self competence and the value of occupations. Timepoint: Before the start of the 12 intervention sessions, after the end of the 12 intervention sessions, one month after the end of the 12 intervention sessions. Method of measurement: Child Occupational Self-Assessment.</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>2022-01-01</approval_date>
        <contact_name>Research Ethics Committees of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
