<?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>IRCT201203119259N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-01-23</date_registration>
      <primary_sponsor>Research center of University of Social Welfare and Rehabilitation sciences</primary_sponsor>
      <public_title>sensory stimulations on motor development of Down syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of simultaneous sensory stimulations and current occupational therapy approaches (neurodevelopmental treatment and rotary vestibular stimulations) on motor development of Down syndrome children with 6 to 18 months of age</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2006-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9839</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The examiner who evaluates the infants  and the child's family are blind to the procedure of the therapy and group's allocation . (double blind).</study_design>
      <phase>1-2</phase>
      <hc_freetext>Motor delay in Down syndrome infants.</hc_freetext>
      <i_freetext>Intervention 1: The Intervention protocol of the experimental  group includes current occupational therapy approaches (facilitatory techniques of  neurodevelopmental therapy and rotary vestibular stimulations ) along with simultaneous extroceptive and proprioceptive stimulations by using herbal sticky pasty on shoulder girdles, elbows, hip girdles and knees. This sticky pasty is applied 30 minutes before the session on the joints  and is desiccated before the start of the intervention. The therapist then uses bondage on elbows and knees. After bondage, the child will be put in different positions using the current occupational therapy approaches and is encouraged for active movements. Intervention 2: The intervention protocol of the control group includes current occupational therapy approaches ( facilitatory techniques of  neurodevelopmental therapy ( NDT) and rotary vestibular stimulation).</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sepideh Nazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Asghar hospital, Dastjerdi Street, Modares Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2304 6362</telephone>
        <email>s-nazi@farabi.tums.ac.ir; sepideh.nazi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sepideh Nazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali Asghar hospital, Dastjerdi Street, Modares Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2304 6362</telephone>
        <email>s-nazi@farabi.tums.ac.ir; sepideh.nazi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : &#13;
1 - having trisomy 21 by genetic karyotype&#13;
2 - 6 to 18 months of age &#13;
3 - having informed consent&#13;
4 - having no severe orthopedic problems or malformations, seizure, uncontrolled thyroid disturbances, severe congenital heart problems ( in need for surgery ), perilabour asphyxia ( Apgar of minutes 1 and 5 equal to or less than 7 ), severe visual or auditory problems, weight less than the 3rd percentile of Down syndrome, and history of the neonatal infections ( meningitis, encephalitis )&#13;
5 - having gestational age of more than 37 weeks &#13;
Exclusion criteria :&#13;
1 - use of rehabilitation services, occupational therapy or physiotherapy in other centers,&#13;
2 - not attending 3 or more consecutive treatment sessions ,&#13;
3 - no participation in treatment sessions for at least 8 sessions in the total intervention course,&#13;
4 - any acute or chronic disease which needs hospitalization or surgery during the intervention</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Q90, Q90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Trisomy 21, meiotic nondisjunction, Trisomy 21, mosaicism (mitotic nondisjunction), Trisomy 21, translocation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The Intervention protocol of the experimental  group includes current occupational therapy approaches (facilitatory techniques of  neurodevelopmental therapy and rotary vestibular stimulations ) along with simultaneous extroceptive and proprioceptive stimulations by using herbal sticky pasty on shoulder girdles, elbows, hip girdles and knees. This sticky pasty is applied 30 minutes before the session on the joints  and is desiccated before the start of the intervention. The therapist then uses bondage on elbows and knees. After bondage, the child will be put in different positions using the current occupational therapy approaches and is encouraged for active movements.</i_keyword>
      <i_keyword>The intervention protocol of the control group includes current occupational therapy approaches ( facilitatory techniques of  neurodevelopmental therapy ( NDT) and rotary vestibular stimulation).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gross motor development score of GMFM (Gross Motor Function Measure). Timepoint: 4 times evaluations ( before, during, after intervention) every 1.5 month. Method of measurement: GMFM ( gross motor function measure).</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>Research center of University of Social Welfare and Rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-03-12</approval_date>
        <contact_name>Ethics committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koodakyar Street, Daneshjoo Boulevard Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
