<?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>IRCT2015031521478N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-10</date_registration>
      <primary_sponsor>Vice- chancellor of  Research and Technology, Arak University of Medical Sciences</primary_sponsor>
      <public_title>Maternal handling training</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the  effects of maternal handling training on occupational performance of children with cerebral palsy and family caregiving satisfaction in Arak city.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18814</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cerebral Palsy.</hc_freetext>
      <i_freetext>Intervention 1: Interventions; for intervention group perform in four phases; pretest, before intervention, intervention and after intervention.&#13;
 Pretest phase: Intervention group receive routine occupational therapy interventions for 4 weeks. Occupational performance for children with CP and level of satisfaction for caregivers assess with COPM. This period is for determine the effectiveness of routine occupational therapy without maternal handling therapy.&#13;
 Before intervention phase: Again, we use COPM for identifying of maternal handling training priorities, occupational performance for children with CP and level of satisfaction for caregivers for intervening group.&#13;
Intervention phase: A 2-hour maternal handling training workshop held for caregivers of the intervention group based on identifying priorities in COPM. During this session, caregivers acquaint with educations for special care of children with CP. After that, a hand book entitled "knowing more about our children and acting better" and video CD in this regard gifts to the caregivers for studying. , Moreover, Over the 3-month period of intervention, intervention group kept on their routine occupational therapy interventions.&#13;
After intervention phase: Differences between occupational performance for children with CP and level of satisfaction for caregivers assess with COPM after 3 month intervention. Intervention 2: Interventions; for control group perform in four phases; pretest, before intervention, intervention and after intervention.&#13;
 Pretest phase: Control group receive routine occupational therapy interventions for 4 weeks. This period is for determine the effectiveness of routine occupational therapy without maternal handling therapy. Occupational performance for children with CP and level of satisfaction for caregivers assess with COPM. &#13;
 Before intervention phase: Again, we use COPM for identifying of maternal handling training priorities, occupational performance for children with CP and level of satisfaction for caregivers for control group.&#13;
Intervention phase: During three month intervention, control group do not receive maternal handling training, but they kept on their routine occupational therapy interventions.&#13;
After intervention phase: Differences between occupational performance for children with CP and level of satisfaction for caregivers assess with COPM after 3 month 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hamid Dalvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Medical science building number 2; Golestan town, Mostafakhomeini Street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381-869-3395</zip>
        <telephone>+98 86 3313 6090</telephone>
        <email>hamiddalvand@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hamid Dalvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Medical science building number 2; Golestan town, Mostafakhomeini Street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>381-869-3395</zip>
        <telephone>+98 86 3313 6090</telephone>
        <email>hamiddalvand@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:children with cerebral palsy (CP) be diagnose by pediatric neurologist ; children with CP aged between 4-12 years old ; children with CP in levels of  III-V Gross Motor Function Classification System Expanded &amp;Revised (GMFCS E&amp;R).&#13;
&#13;
Exclusion criteria: CP children with refractory seizure ; CP children with Muscular – skeleton surgery.</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral palsy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions; for intervention group perform in four phases; pretest, before intervention, intervention and after intervention.&#13;
 Pretest phase: Intervention group receive routine occupational therapy interventions for 4 weeks. Occupational performance for children with CP and level of satisfaction for caregivers assess with COPM. This period is for determine the effectiveness of routine occupational therapy without maternal handling therapy.&#13;
 Before intervention phase: Again, we use COPM for identifying of maternal handling training priorities, occupational performance for children with CP and level of satisfaction for caregivers for intervening group.&#13;
Intervention phase: A 2-hour maternal handling training workshop held for caregivers of the intervention group based on identifying priorities in COPM. During this session, caregivers acquaint with educations for special care of children with CP. After that, a hand book entitled "knowing more about our children and acting better" and video CD in this regard gifts to the caregivers for studying. , Moreover, Over the 3-month period of intervention, intervention group kept on their routine occupational therapy interventions.&#13;
After intervention phase: Differences between occupational performance for children with CP and level of satisfaction for caregivers assess with COPM after 3 month intervention.</i_keyword>
      <i_keyword>Interventions; for control group perform in four phases; pretest, before intervention, intervention and after intervention.&#13;
 Pretest phase: Control group receive routine occupational therapy interventions for 4 weeks. This period is for determine the effectiveness of routine occupational therapy without maternal handling therapy. Occupational performance for children with CP and level of satisfaction for caregivers assess with COPM. &#13;
 Before intervention phase: Again, we use COPM for identifying of maternal handling training priorities, occupational performance for children with CP and level of satisfaction for caregivers for control group.&#13;
Intervention phase: During three month intervention, control group do not receive maternal handling training, but they kept on their routine occupational therapy interventions.&#13;
After intervention phase: Differences between occupational performance for children with CP and level of satisfaction for caregivers assess with COPM after 3 month intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Occupational Performance of children with CP &amp; Caregiver Satisfaction. Timepoint: Data gather in three phases; pre-test (4 weeks before intervention), before interventions and 3 month  after interventions. Method of measurement: Occupational Performance of children with CP and  Caregiver Satisfaction (both) measure with Canadian Occupational Performance Measure (COPM).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Maternal Handling Training. Timepoint: Before and 3 months after intervention. Method of measurement: Canadian Occupational Performance Measure (COPM).</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>Vice- chancellor of  Research and Technology, Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-02</approval_date>
        <contact_name>Arak University of Medical Sciences</contact_name>
        <contact_address>School of Rehabilitation, Medical science building number 2; Golestan town, Mostafakhomeini Street. Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
