<?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>IRCT20150531022498N33</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-06</date_registration>
      <primary_sponsor>Occupational therapy center</primary_sponsor>
      <public_title>Effect of circuit training on cerebral palsy children</public_title>
      <acronym></acronym>
      <scientific_title>Effect of circuit training on some physiological factors, lower leg muscle activity, gross motor function and activity daily living on spastic cerebral palsy children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48010</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: The present study is a randomized controlled trial that thirty four children were selected as participants in the research process. After the necessary investigations and based on the information of the completed questionnaires, the subjects were divided into two groups of 17 people using a lottery by simple random method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cerebral Palsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 12 weeks of high intensity circuit training, three sessions per week, in each training session of 3 round of training circle, which consists of 6 training stations, with 30 seconds of exercise and 30 seconds break between, them as: sit to stand exercise, heel rises, forward lunges, and a lateral step-up exercise, lifting the medicine ball of the floor and placing on the chair and a motivational game station throwing off the ball Within the basket of 5 meters from a warm-up at the beginning of the session and a cool down at the end of the session. in addition 12 weeks and one session per week of normal occupational therapy training. Intervention 2: Control group: 12 weeks and one session per week of normal occupational therapy.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No decision has been made yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arash Nasiri Woshmesaraei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4153911900</zip>
        <telephone>+98 13 4466 5179</telephone>
        <email>arashnasiriot@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ramin Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 2153</telephone>
        <email>shabani_msn@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having age ranges of 7-16 years
Spastic diplegia cerebral palsy
Ambulation ability</inclusion_criteria>
      <agemin>7 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>More than three session absence from the training
Botox injection or surgery in period of intervention</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 12 weeks of high intensity circuit training, three sessions per week, in each training session of 3 round of training circle, which consists of 6 training stations, with 30 seconds of exercise and 30 seconds break between, them as: sit to stand exercise, heel rises, forward lunges, and a lateral step-up exercise, lifting the medicine ball of the floor and placing on the chair and a motivational game station throwing off the ball Within the basket of 5 meters from a warm-up at the beginning of the session and a cool down at the end of the session. in addition 12 weeks and one session per week of normal occupational therapy training</i_keyword>
      <i_keyword>Control group: 12 weeks and one session per week of normal occupational therapy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gross Motor Function. Timepoint: Before an after of end of intervention. Method of measurement: Using Gross Motor Function Measure (GMFM).</prim_outcome>
      <prim_outcome>Lower leg muscle activity. Timepoint: Before an after of end of intervention. Method of measurement: Using Electromyography device ( EMG and evoked-potentialemg-meb-9400k ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body composition. Timepoint: before and after the end of intervention. Method of measurement: With the use of weights, height, gender and SAEHAN Hand Calipers and the Slater Kids Body Composition formula.</sec_outcome>
      <sec_outcome>Strength. Timepoint: Before an after of end of intervention. Method of measurement: Using SAEHAN Hand-Grip Dynamometer and SAEHAN Back, Leg &amp; Chest Dynamometer.</sec_outcome>
      <sec_outcome>Balance. Timepoint: Before an after of end of intervention. Method of measurement: Using Berg Balance Scale.</sec_outcome>
      <sec_outcome>6 Minute Walk Distance. Timepoint: Before an after of end of intervention. Method of measurement: 6 Minute Walk Test.</sec_outcome>
      <sec_outcome>Activity Daily Living. Timepoint: Before an after of end of intervention. Method of measurement: Using Activity Scale for Kids (ASK).</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>Occupational therapy center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-06</approval_date>
        <contact_name>Ethics Committee of Azad University Rasht Branch</contact_name>
        <contact_address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
