<?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>IRCT20230416057922N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-18</date_registration>
      <primary_sponsor>Allameh Tabataba'i University</primary_sponsor>
      <public_title>computer-assisted cognitive rehabilitation and game-based neuropsychological rehabilitation for students with specific learning disabilities</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of computer-assisted cognitive rehabilitation and game-based neuropsychological rehabilitation for students with specific learning disabilities</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>153</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72481</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The participants will be divided into two intervention groups and one control group using a randomization sequence that will be created beforehand. This sequence will be completely random and unpredictable. To allocate the participants, a block randomization method will be employed, involving 9 blocks. By utilizing random number generation software with the block method, the randomization sequence will be generated based on the required sample size for the two groups. The process of assigning participants to groups will be facilitated by a software called Sealed Envelope. 
Additional Information: In order to generate the list, we take into account 9 different block sizes and a total list length of 153. Within the treatment groups, we have three specific groups: Group A, Group B, and Group C. Using the software, we create 10 blocks, each containing 9 options. Out of the total 153 codes, 51 will be assigned to Group A, 51 to Group B, and 51 to Group C. 
This software ensures that concealment is maintained during the allocation process. Concealment refers to the unpredictability of assigning individuals to specific groups. It means that the researcher will not be able to predict which group the next person will be assigned to. This helps to minimize any potential bias or influence in the allocation process, ensuring a fair and unbiased distribution of participants across the interventions and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>specific learning disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The group received computer-based cognitive rehabilitation with a designed package for two months. This intervention is done in 25 sessions. These interventions are received by a computer called Captain Log. Games and activities that require a computer and the program is installed on it. Usually, each activity lasts between 20 and 45 minutes. Captain Log contains motivational and entertaining videos. By activating the brain reward cycle, the exercises and training patterns of the software lead to encouraging people to improve and improve their performance. Visual recognition, auditory recognition, number perception, sequential conceptual patterns and types of memory ( visual memory), (auditory memory), (active memory), (memory sequence).- Captain's Log cognitive software first conducts a 9-step test for the person according to the specified age of the client, The report of the person's acceptance in each of the nine stages of the test and the report of the average response time to the test questions (Reaction Time) and a complete comparison chart are provided to the examiner. In the next step, the examiner can use the treatment program recommended by the software. The application will have, according to the test performed a customized plan chosen by the therapist from among about 50 types of exercises in 3 different levels (about 150 exercises). Intervention 2: Intervention group: The game-based neuropsychological rehabilitation group receives the designed package during two months, which is 25 sessions of 45 groups and is held 4 times a week. This program tries to improve children's cognitive and psychological functions through games and exercises. Hasanalizadeh et al. (2017) have used this program in 16 sessions to improve the psychological functions of children with developmental delay. Intervention 3: Control group: routin education.</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:
Quantitative Data

When:
After publishing

To whom:
will be accessible based on email request

Conditions:
analyzing

Where to obtain:
corresponding author

How to obtain:
mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Asgar Alimohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dehkade olampic</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۸۹۶۸۴۵۱۱</zip>
        <telephone>+98 21 4839 3194</telephone>
        <email>asgar.alimohamadi@yahoo.com</email>
        <affiliation>Allameh Tabataba'i University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>َAsgar Alimohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dehkadeh olampic</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۸۹۶۸۴۵۱۱</zip>
        <telephone>+98 21 4839 3194</telephone>
        <email>asgar.alimohamadi@yahoo.com</email>
        <affiliation>Allameh Tabataba'i University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The revised main criteria for entering the study are as follows      1. Being between the ages of 6 and 12 years old                            2. Meeting the criteria for a specific learning disorder as diagnosed by a specialist                                                                   3. Obtaining informed consent from parents to participate in the study</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>comorbid disorders such as ADHD and drug use
existence of severe language and non-verbal problems as diagnosed by the psychologist</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The group received computer-based cognitive rehabilitation with a designed package for two months. This intervention is done in 25 sessions. These interventions are received by a computer called Captain Log. Games and activities that require a computer and the program is installed on it. Usually, each activity lasts between 20 and 45 minutes. Captain Log contains motivational and entertaining videos. By activating the brain reward cycle, the exercises and training patterns of the software lead to encouraging people to improve and improve their performance. Visual recognition, auditory recognition, number perception, sequential conceptual patterns and types of memory ( visual memory), (auditory memory), (active memory), (memory sequence).- Captain's Log cognitive software first conducts a 9-step test for the person according to the specified age of the client, The report of the person's acceptance in each of the nine stages of the test and the report of the average response time to the test questions (Reaction Time) and a complete comparison chart are provided to the examiner. In the next step, the examiner can use the treatment program recommended by the software. The application will have, according to the test performed a customized plan chosen by the therapist from among about 50 types of exercises in 3 different levels (about 150 exercises).</i_keyword>
      <i_keyword>Intervention group: The game-based neuropsychological rehabilitation group receives the designed package during two months, which is 25 sessions of 45 groups and is held 4 times a week. This program tries to improve children's cognitive and psychological functions through games and exercises. Hasanalizadeh et al. (2017) have used this program in 16 sessions to improve the psychological functions of children with developmental delay.</i_keyword>
      <i_keyword>Control group: routin education</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Executive function. Timepoint: pre test-post test. Method of measurement: In this research, executive function tools including the Continuous Attention Test, BRIEF2 Test, Working Memory Test, and Motor Skills Test will be used.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>None. Timepoint: none. Method of measurement: none.</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>Allameh Tabataba'i University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-09</approval_date>
        <contact_name>The committee of ethics in research of Allameh Tabatabai University</contact_name>
        <contact_address>Iran. Tehran, Dehkadeh olampic tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
