<?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>IRCT20190309042983N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-30</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Fine Motor Training on linguistic and motor skills</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Fine Motor Training on Language and Motor Skills in Children with Intellectual Disabilities</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38140</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, case and control groups will be randomized through the stratified randomization so that in addition to the same sample size, variables such as IQ, linguistic and motor skills should be the same in the two groups. The results and final differences between the two groups can be understood as the effect of interventions in the case group. After applying these layers, homogeneous individuals in each layer will be randomly assigned to one of the case and control groups based on random numbers.
Hiding in this study will be done by an instructor. Speech therapist, occupational therapist, psychologist and even parents of these children will be unaware of being or not taking each child in the case and control group, Blinding description: Participants: From the parents, all participants (both case and control groups) received written consent for participation in the study, but consent will be made that the participating children will be randomly divided into two groups and only one intervention group, mean your baby will have 50 percent chance of receiving an intervention.
The main researcher (Ehsan Hemmati) is not involved in sampling, and his colleague will conduct linguistic assessments. Health workers (therapist, speech therapist, and psychologist) who evaluate the initial and final evaluation will also not be aware of the allocation of any children in the groups and will be required to accurately assess all the children participating (case and control) and The final allocation of these children will be done by the trainer. After the end of the interventions, the initial and final information of both groups was collected by the educational instructor and the statistics expert will be presented for analysis and comparison of the results of the two groups (without specifying the case group from the control).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Intellectual Disabilities.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, the educational protocol of drawing (Homa design) as an intervention for fine motor training to the children of the intervention group is used. This protocol, which is designed to measure the ability of visual arts for people with special needs, determines the ability to draw these children. In this intervention, each child is trained individually, two sessions per week for six months. This intervention has been designed in five main attributes, including understanding the shape, understanding positioning, understanding the size, drawing power and the precision in drawing that is necessary for painting, which is arranged in 15 columns and in a single page. To run this test, the instructor will ask the child to draw the same box as the test form in the blank box of the same page and then score the child according to the scoring criterion. According to the score, the child will be placed in one of the six levels of the test, and according to his level, he will start specific training. The A level test is all about Blatter, and the person is able to draw complicated subjects with fit and perfect composition. Level B includes intricate topics with low detail, C level, simple threads with wide color surfaces with distinct and large detail, D level, simple threads with wide color surfaces with distinct, large and small detail, E Simple threads with wide color surfaces with distinct layouts, without the details, and level F, include lines, dots, and sprays of simple colors and incomplete levels. In this plan, sub-classes B to F is assigned classed exercises to obtain the ability to perform exercises. These exercises include point-related, line-related, color-related, and related-level exercises. Intervention 2: Control group: Routine care=.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ehsan Hemmati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 13, 30tir Ave., Hafez Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 51 3881 3434</telephone>
        <email>hemmati.e@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad-Taghi Joghataei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran university of medical sciences, Hemmat Blvd.</address>
        <city>Tehran</city>
        <country1>Argentina</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 86701</telephone>
        <email>joghataei@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The child is a person with educable intellectual disabilities on the basis of an IQ of 50 to 70, and the Vineland Social Maturity Scale.
The language age of the child is at the stage of the emerging or progress of the language, which is determined by the form of the PANA profile.
The child is a Persian language and speaks only in Persian at home, which is based on the Persian language of the child's question of parents.
The child's parents have literacy skills that can read and respond to checklist, which is obtained through parenting questions.
According to a parent's report, the child has no hearing impairment.
According to the parents of children who are blind or severely visually impaired is not.</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If the examinations (pre-test or post-test) occupational therapy, speech therapy or psychology for children has not been done.
The child's parents did not respond to more than half of the checklists questions.
The child has autism diagnosis, which, if suspected, is evaluated by a psychiatrist.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F70</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild intellectual disabilities</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: In this study, the educational protocol of drawing (Homa design) as an intervention for fine motor training to the children of the intervention group is used. This protocol, which is designed to measure the ability of visual arts for people with special needs, determines the ability to draw these children. In this intervention, each child is trained individually, two sessions per week for six months. This intervention has been designed in five main attributes, including understanding the shape, understanding positioning, understanding the size, drawing power and the precision in drawing that is necessary for painting, which is arranged in 15 columns and in a single page. To run this test, the instructor will ask the child to draw the same box as the test form in the blank box of the same page and then score the child according to the scoring criterion. According to the score, the child will be placed in one of the six levels of the test, and according to his level, he will start specific training. The A level test is all about Blatter, and the person is able to draw complicated subjects with fit and perfect composition. Level B includes intricate topics with low detail, C level, simple threads with wide color surfaces with distinct and large detail, D level, simple threads with wide color surfaces with distinct, large and small detail, E Simple threads with wide color surfaces with distinct layouts, without the details, and level F, include lines, dots, and sprays of simple colors and incomplete levels. In this plan, sub-classes B to F is assigned classed exercises to obtain the ability to perform exercises. These exercises include point-related, line-related, color-related, and related-level exercises.</i_keyword>
      <i_keyword>Control group: Routine care=</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The language skills and gross and fine motor skills. Timepoint: At the beginning of the study and the end of the intervention. Method of measurement: Through questionnaires, checklists and record sample and speech analysis.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-06</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University Medical Sciences, Hemmat freeway, next to Milad tower, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
