<?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>IRCT20250306064948N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-06</date_registration>
      <primary_sponsor>Islamic Azad University- Ahvaz Branch</primary_sponsor>
      <public_title>The comparison of the effectiveness of sensory-motor integration and cognitive rehabilitation on slow learner students</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effectiveness of sensory-motor integration and cognitive rehabilitation on executive functions (attention, working memory and inhibition), fine motor skills, and reading of slow learner students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82369</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The statistical population includes all borderline intellectual functioning students in Sari. The sampling method is purposive; the sample consists of elementary school students (except for first grade) in the 2024–2025 academic year in Sari. These students may have a record in the SANAD system, a school referral letter, or may have visited the city's Special Learning Disability Centers at their parents' request. From this group, 45 students will be selected using a purposive sampling method. After administering specialized tests, they will be randomly assigned to three groups, Blinding description: Since the placement of participants in each of the three groups is random, only the rehabilitation method used in each group will be explained.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Weaknesses in Executive Functions (Attention, Working Memory, Inhibition) of Slow Learner Students, Weaknesses in Fine Motor Skills of Slow Learner Students, Weaknesses in Reading Skills of Slow Learner Students.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group with Sensory- Motor Integration Method: 15 eligible subjects were randomly assigned to this group and provided with a sensory - motor integration training package over 14 sessions (one session per week) along with related activities and homework that could be tracked by reviewing photos, short videos, or audio recordings of how homework was done at home, which were sent by parents every day between sessions. Intervention 2: The second intervention group with Cognitive Rehabilitation Method: 15 eligible subjects were randomly assigned to this group and provided with a cognitive rehabilitation training package over 14 sessions (one session per week) along with related activities and homework that could be tracked by reviewing photos, short videos, or audio recordings of how homework was done at home, which were sent by parents every day between sessions. Intervention 3: Control group: without any intervention.</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:
All data is potentially shareable after anonymizing individuals

When:
The access period begins 6 months after the publication of the results

To whom:
All researchers working in academic and scientific institutions, specialists in psychology with fields related to the research topic, students, and researchers in this area

Conditions:
The results and data of the research will be presented to improve the living and educational conditions of slow learner students

Where to obtain:
Specialized websites, reputable related journals, and the researcher's email address

How to obtain:
After the completion of the research, final presentation of the results, and defense, the information will be published and, depending on the time required for publication, it will be accessible from related credible sources

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Fazel Masaeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of Seyyed Razi Sadati Alley, Shahid Bahonar Alley, Western Beltway</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816964434</zip>
        <telephone>+98 11 3321 6156</telephone>
        <email>Maryamfm49@gmail.com</email>
        <affiliation>Islamic Azad University, Ahvaz Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Fazel Masaeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of Seyyed Razi Sadati Alley, Shahid Bahonar Alley, Western Beltway</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816964434</zip>
        <telephone>+98 11 3321 6156</telephone>
        <email>Maryamfm49@gmail.com</email>
        <affiliation>Islamic Azad University, Ahvaz Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Attendance in primary education except for the first grade
Having a borderline intellectual functioning</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>13 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having potential comorbid disorders
Receiving simultaneous rehabilitation</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>The first intervention group with Sensory- Motor Integration Method: 15 eligible subjects were randomly assigned to this group and provided with a sensory - motor integration training package over 14 sessions (one session per week) along with related activities and homework that could be tracked by reviewing photos, short videos, or audio recordings of how homework was done at home, which were sent by parents every day between sessions.</i_keyword>
      <i_keyword>The second intervention group with Cognitive Rehabilitation Method: 15 eligible subjects were randomly assigned to this group and provided with a cognitive rehabilitation training package over 14 sessions (one session per week) along with related activities and homework that could be tracked by reviewing photos, short videos, or audio recordings of how homework was done at home, which were sent by parents every day between sessions.</i_keyword>
      <i_keyword>Control group: without any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Executive Functions (attention, working memory ,inhibition) of slow learner students. Timepoint: Measuring Executive Functions (Attention, Working Memory, Inhibition) of slow learner students at the beginning of the study (before the intervention) and after 14 sessions of implementing two rehabilitation methods for each participant in two intervention groups. Method of measurement: Measurement of Executive Functions (Attention with the Stroop Test, Working Memory with the WMTB-C Test,  Inhibition with the Go-No Go Test).</prim_outcome>
      <prim_outcome>Fine motor skills of slow learner students. Timepoint: Measuring Fine Motor Skills of slow learner students at the beginning of the study (before the intervention) and after 14 sessions of implementing two rehabilitation methods for each participant in two intervention groups. Method of measurement: Measurement of Fine Motor Skills with the Bruininks-Oseretsky Test.</prim_outcome>
      <prim_outcome>Reading of slow learner students. Timepoint: Measuring Reading of slow learner students at the beginning of the study (before the intervention) and after 14 sessions of implementing two rehabilitation methods for each participant in two intervention groups. Method of measurement: Measurement of Reading Skills with the Nema Reading 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>Islamic Azad University- Ahvaz Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-03</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University – Ahvaz Branch</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Ahvaz Branch, Islamic Azad University, Farhang Shahr Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
