<?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>IRCT20200905048619N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-09</date_registration>
      <primary_sponsor>Kharazmi university</primary_sponsor>
      <public_title>To study the role of CPF motor learning on balance control in hemiplegic CP children</public_title>
      <acronym></acronym>
      <scientific_title>Use of Challenge Point Framework to Guide Motor Learning of Stepping Reactions for Improved Balance Control in Children with Unilateral Cerebral Palsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50748</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Balance disorder in unilateral cerebral palsied children.</hc_freetext>
      <i_freetext>Intervention group: received 12 sessions (twice a week) exercises based on challenge point framework. Each session lasted for 45 minutes.  In this procedure, the person was asked to bend from the ankle joint in four directions, forward, backward, right and left, while standing. People should not try to prevent falling, but should allow themselves to fall like a fallen tree, to the point where they feel they have to take a step to prevent it from falling..</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 If it is necessary, it will be send</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Somayeh Ashouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kharazmi university, Kousha St., Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>158754398</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>so_ashouri@yahoo.com</email>
        <affiliation>Kharazmi university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Somayeh Ashouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kharazmi university, Kousha St.,Mirdamad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>158754398</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>so_ashouri@yahoo.com</email>
        <affiliation>Kharazmi university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to walk without the help of a person or assistive device for at least six minutes
Ability to understand and follow the therapist's guidelines
Levels one to three of the GMFCS
Hemiplegic cerebral palsied children aged 4 to 12</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Convulsion during the study or any disease that interfered with the study process.  ,
Failure to attend three consecutive sessions
Heart disease, and severe vision or hearing problems
Refusing to complete the training sessions</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: received 12 sessions (twice a week) exercises based on challenge point framework. Each session lasted for 45 minutes.  In this procedure, the person was asked to bend from the ankle joint in four directions, forward, backward, right and left, while standing. People should not try to prevent falling, but should allow themselves to fall like a fallen tree, to the point where they feel they have to take a step to prevent it from falling.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Step length in stepping reaction. Timepoint: Pre-test1, pre-test2, post-test. Method of measurement: Tracker software to estimate  step length.</prim_outcome>
      <prim_outcome>Step velocity in stepping reaction. Timepoint: Pre-test1, pre-test2, post-test. Method of measurement: Tracker software to estimate  step velocity.</prim_outcome>
      <prim_outcome>Statics and Dynamic balance. Timepoint: Pre-test1, pre-test2, post-test. Method of measurement: Pediatric Balance Scale (PBS) to test static and dynamic balance.</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>Kharazmi university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-28</approval_date>
        <contact_name>Ethics committee of research of Kharazmi university</contact_name>
        <contact_address>No.2,Shaqayeq Alley,Golha town,Southern Nabard St.,Pirouzi Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
