<?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>IRCT20171219037953N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-08</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the efficacy of mixed training regimen of verbal working memory in dyslexic children</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the efficacy of mixed training regimen of verbal working memory and visuo-motor activity on verbal working memory, postural control and reading skills in persian dyslexic children, aged 6 to 12 years</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28515</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Training regimen will be done by self-manufactured trainer robot for 4 weeks, 3 times a week, 30 to 45 minutes in every sessions, Randomization description: After selecting the available samples based on the inclusion criteria, Individuals are randomly (coin throwing method) divided into two groups, experiment (EG) and active control (CG).
Head of the coin, EG (10-20).
Tail of the coin, CG (10-20), Blinding description: In this double-blinded study, blinding will be applied to all participants and outcome assessment.
Blinding of participants is possible. They will not know in which group they have been placed. Although, parent will know in which group their child has been placed. After finishing the treatment period, the data will be analyzed by a blinded statistician who will receive coded data. He/she will not know who is participating in which group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Developmental dyslexia or specific reading disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: participants in this group will receive the mixed training regimen of verbal working memory and visual-motor activity: presenting the word; decomposition of the word to it’s letters/ moving of the platform; repetition of the previous step by Active movements of the child; retrieving the letters of the word. Intervention 2: Control group: participants in this group will receive the training of verbal working memory: presenting the word; decomposition of the word to it’s letters; retrieving the letters of the word.</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:
age
score of full IQ
sex
scores of verbal working memory
scores of postural control parameters
changes of functional connectivity
scores of reading subtests

When:
6 month after publication of papers

To whom:
active researchers

Conditions:
scientific using

Where to obtain:
electronic post address

How to obtain:
until one month after request

Comments:
no</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Ramezani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hemmat highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14665354</zip>
        <telephone>+98 21 81631</telephone>
        <email>ergotherapist.ramezani@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Ramezani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hemmat highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14665354</zip>
        <telephone>+98 21 3340 1194</telephone>
        <email>ergotherapist.ramezani@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosing dyslexia by WISC IV
Aged 6-12 y
Students of Schools in Tehran and the moderate socioeconomic status
Right-handed
Normal or corrected to normal visual acuity
Normal hearing status
No history of head injury
No history of psychiatric disorders
Full IQ score greater than 85
Without co morbidity with ADHD
Persian monolingual
Do not using of druges affect on attention</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not attending in pretest assessment and training sessions
Participation in training sessions Less than 75% of all sessions/ less than 9 sessions out of 12 sessions
Not attending in post-test assessment sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F81.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Specific reading disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: participants in this group will receive the mixed training regimen of verbal working memory and visual-motor activity: presenting the word; decomposition of the word to it’s letters/ moving of the platform; repetition of the previous step by Active movements of the child; retrieving the letters of the word.</i_keyword>
      <i_keyword>Control group: participants in this group will receive the training of verbal working memory: presenting the word; decomposition of the word to it’s letters; retrieving the letters of the word.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Verbal working memory. Timepoint: Before and after treatment, 4-5 weeks. Method of measurement: Forward and backward digit span.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postural control. Timepoint: Before and after treatment-4 to 5 weeks. Method of measurement: Cop data of force platform tool.</sec_outcome>
      <sec_outcome>Reading Skills. Timepoint: Before and after treatment-4 to 5 weeks. Method of measurement: Scores of reading skills native battery sub tests.</sec_outcome>
      <sec_outcome>Changes in functional connectivity of VI and Crus I lobules of the cerebellum. Timepoint: Before and after treatment-4 to 5 weeks. Method of measurement: Resting-state fMRI.</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>2017-12-08</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>Hemmat highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
