<?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>IRCT20230707058703N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-27</date_registration>
      <primary_sponsor>The university of faisalabad</primary_sponsor>
      <public_title>Effects Of Spider Cage Therapy On Motor Control Of Hemiplegic Cerebral Palsy Children</public_title>
      <acronym></acronym>
      <scientific_title>Effects Of Spider Cage Therapy On Motor Control Of Hemiplegic Cerebral Palsy Children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71157</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to inclusion criteria, all the enrolled participants would be allocated into two groups.
 Randomly allocated by lottery method.
 Participants would be randomly assigned to two groups one group was experimental group this group received spider cage therapy.
 While second group was control group received conventional therapy.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Hemiplegic cerebral palsy children.</hc_freetext>
      <i_freetext>Intervention 1: “Intervention group:” This group received spider cage therapy for motor control like kneeling, half kneeling, one leg standing and jumping by using gross motor function scale. Five days in a week. Start with general body warm exercises then spider cage therapy. Intervention 2: “Control group:” this group received conventional therapy in which stretching exercises were performed. Before this general body warm exercise were performed thẹn stretching exercises. 5 days in a week.</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:
Effects of spider cage therapy on motor control of hemiplegic cerebral palsy children.
 A randomization clinical trial

When:
Data will be available for other people almost 6 months after the completion of study

To whom:
Data will be available for other people almost 6 months after the completion of study

Conditions:
The data/document could be used by communicating with the principle investigator Aleena Mubarak gmail: aleenachaudhry42@gmail.com

Where to obtain:
Aleena Mubarak gmail: aleenachaudhry42@gmail.com

How to obtain:
The data/document could be used by communicating with the principle investigator Aleena Mubarak gmail: aleenachaudhry42@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aleena mubarak</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no 39, 40 block b cant view sargodha</address>
        <city>Sargodha</city>
        <country1>Pakistan</country1>
        <zip>40100</zip>
        <telephone>+92 48 3750816</telephone>
        <email>Aleenachaudhry42@gmail.com</email>
        <affiliation>The university of faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Areesha jameel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>709-b peoples colony no 1</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 321 7607141</telephone>
        <email>Baigasma95@gmail.com</email>
        <affiliation>Nusrat abdul rauf center of enablement</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children diagnosed with hemiplegic cerebral palsy
Age between 4-10
Both male and females
Modified Ashworth Scale ( Grade 2)
Able to cooperate and motivated was include in the study
Cp children who was able to understand and follow verbal commands was added in training and evaluation
Gross motor function scale level: II</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children with severe disability, seizure instability waiting for surgery
Mentally retarded
Multiple contractures
Multiple any bone diseases
Multiple deformity
Hemiplegic with meningitis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Hemiplegic</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>G80.2</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:” This group received spider cage therapy for motor control like kneeling, half kneeling, one leg standing and jumping by using gross motor function scale. Five days in a week. Start with general body warm exercises then spider cage therapy</i_keyword>
      <i_keyword>“Control group:” this group received conventional therapy in which stretching exercises were performed. Before this general body warm exercise were performed thẹn stretching exercises. 5 days in a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gross motor function scale -88(item b, c and d). Timepoint: Before intervention and 3,6 and 9 week after intervention. Method of measurement: Gross motor function scale-88 used to measure the motor ability of hemiplegic  cerebral palsy childeren by using spider cage unit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Modified Ashworth scale. Timepoint: Baseline , 3,6 and 9 week. Method of measurement: Modified ashworth scale used to measure the spasticity of hemiplegic cerebral palsy children.</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>Self funding</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-08</approval_date>
        <contact_name>Ethical Review Commitee</contact_name>
        <contact_address>University Avenue, Faisal town canal road, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
