<?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>IRCT20210805052088N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-15</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>comparison between Rood inhibitory approach and Bobath Reflex inhibiting pattern to improve Gross motor function and reduce spasticity in hemiplegic children of encephalitis</public_title>
      <acronym></acronym>
      <scientific_title>comparison between Rood inhibitory approach and Bobath Reflex inhibiting pattern to improve Gross motor function and reduce spasticity in hemiplegic children of encephalitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57957</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized clinical design, Randomization description: Non-probability purposive sampling technique will be utilized to collect sample and the sample will be allocated to treatment group 1 and 2 by using lottery method.Screening of population will be done by using, selected inclusion and exclusion criteria.Lottery method basically is a chit and draw method during allocation make the chits and than said the patients that please collect any one chit than enrolled the patient in respective group.In a chit-pull system, a number of chits is first placed in a container (often a bag or cup). ... In the course of the game, chits are drawn randomly out of this container, triggering certain game effects. This is essentially just another way of producing random results.Patients who met the eligibility criteria will be enrolled in the study.During randomization patients fully blinded than allocate the patients into treatment group 1(Rood inhibitory approach) and treatment group 
2(Bobath reflex inhibiting pattern), Blinding description: Patients will be kept blind through allocation concealment to treatment groups.Patients will be unaware of their respective group treatment plans.Patients who met the eligibility criteria will be enrolled in the study.During randomization patients fully blinded than allocate the patients into treatment group 1(Rood inhibitory approach) and treatment group 2(Bobath reflex inhibiting pattern).Basically blinding in research prevent biasness in the study.Patients will be fully unknown about the allocation procedure because used lottery method for allocation of the patients.</study_design>
      <phase>3</phase>
      <hc_freetext>Encephalitis is defined as inflamation of brain caused by any viral and bacterial infection but in different researches cause of encephalitis is unknown due to encephalitis patients present with the symptoms of fever,vomiting,headach,spasticity,muscle weakness etc..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:Rood Inhibitory Approach will be receive of group 1 in alternatives days for 4 month duration after the approval of synopsis.•After allocation to treatment Group A and B, level of spasticity will be recorded using modified Ashworth Scale.•GMFM-88 and GMFM-66 scale will also be used to record the improvement of Gross Motor Functional Movements.•Measurement will  also be recorded pretreatment.•First reading will be taken on baseline before treatment session•Each reading was taken after the treatment session of 15 days •Data will be collected before treatment and after 2, 4 and 6 weeks of intervention.•Infrared: On baseline for 15 min.•Rood (Inhibitory): Group 1 will be receiving Rolling, Shaking, Slow joint compression, Maintain stretch for 30 mints in alternative days.	.Rood inhibitory approach basically is generally accepted.This approach is used to homogenize the muscle tone,correcting the body postures,positioning and improve gross motor functions. Basically its a stretching and specialized method of handling. Intervention 2: Intervention group 2: Bobath reflex inhibiting patterns technique will be apply in group 2 patients in alternatives days for 4 month duration after the approval of synopsis.•After allocation to treatment Group A and B, level of spasticity will recorded using modified Ashworth Scale.•GMFM-88 and GMFM-66 scale will also be used to record the improvement of Gross Motor Functional Movements.•Measurement will also be recorded pretreatment.•First reading will taken on baseline before treatment session•Each reading will taken after the treatment session of 15 days•	Data will be collected before treatment and after 2, 4 and 6 weeks of intervention.Group 2 will be received infrared on baseline for 15 minutes and bobath reflex inhibiting pattern in which traction and light joint compression will be receive for 30 minutes in alternative days. Bobath reflex inhibiting pattern and posture also called tone influencing pattern and postures includes spasticity inhibiting position and postures so the person can move his body parts by his/her on wil. This make the person independent in his daily activities.When the stimulation is given in inhibitory postures than the chance in increase spasticity decrease rapidly.</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 It will be decided later on as per the advice of supervisor and the requirements of the journal in which the article will be sent for publication</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Noor-ul-ain</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamalia Road banglaw chowk mamunkanjan faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8502460</telephone>
        <email>noorulainjerry@yahoo.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Noor-ul-ain</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kamalia road banglaw chowk mamunkanjan faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8502460</telephone>
        <email>noorulainjerry@yahoo.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both gender
Hemiplegic Spastic Encephalitis Children
Age should be between 2 year to 15 years
Spasticity of grade 1 to 3 through Modified Ashworth Scale
Written Informed Consent.
Chronic Encephalitis children</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Spasticity because of any other disease e.g. CP and stroke etc
Children having fits and tremors and any red flag sign
Children taking any other physical therapy treatment during this study
Severe Mental Retardation, Contractures, Decrease Tone
Tumor, fractures and any other severe infections
Red flag signs that may indicate cauda equina syndrome, such as bladder and bowel  Dysfunction and saddle anesthesia
History of spinal surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G04.90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encephalitis and encephalomyelitis, unspecified</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 1:Rood Inhibitory Approach will be receive of group 1 in alternatives days for 4 month duration after the approval of synopsis.•After allocation to treatment Group A and B, level of spasticity will be recorded using modified Ashworth Scale.•GMFM-88 and GMFM-66 scale will also be used to record the improvement of Gross Motor Functional Movements.•Measurement will  also be recorded pretreatment.•First reading will be taken on baseline before treatment session•Each reading was taken after the treatment session of 15 days •Data will be collected before treatment and after 2, 4 and 6 weeks of intervention.•Infrared: On baseline for 15 min.•Rood (Inhibitory): Group 1 will be receiving Rolling, Shaking, Slow joint compression, Maintain stretch for 30 mints in alternative days.	.Rood inhibitory approach basically is generally accepted.This approach is used to homogenize the muscle tone,correcting the body postures,positioning and improve gross motor functions. Basically its a stretching and specialized method of handling.</i_keyword>
      <i_keyword>Intervention group 2: Bobath reflex inhibiting patterns technique will be apply in group 2 patients in alternatives days for 4 month duration after the approval of synopsis.•After allocation to treatment Group A and B, level of spasticity will recorded using modified Ashworth Scale.•GMFM-88 and GMFM-66 scale will also be used to record the improvement of Gross Motor Functional Movements.•Measurement will also be recorded pretreatment.•First reading will taken on baseline before treatment session•Each reading will taken after the treatment session of 15 days•	Data will be collected before treatment and after 2, 4 and 6 weeks of intervention.Group 2 will be received infrared on baseline for 15 minutes and bobath reflex inhibiting pattern in which traction and light joint compression will be receive for 30 minutes in alternative days. Bobath reflex inhibiting pattern and posture also called tone influencing pattern and postures includes spasticity inhibiting position and postures so the person can move his body parts by his/her on wil. This make the person independent in his daily activities.When the stimulation is given in inhibitory postures than the chance in increase spasticity decrease rapidly.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gross motor functional scale will use to measure the Gross motor functions and it is a primary outcome measure scale. Timepoint: two times reading will be measure before treatment and after the treatment session in last follow up. Method of measurement: Gross motor functional scale will be utilized to asses the gross motor functional movements.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Secondary outcome measure of this study will be Modified Ashworth scale.Modified ashworth scale will be used to measure the spasticity. Timepoint: Reading will be measure before treatment session and after 1st follow up,2nd follow up,3rd follow up,4th follow up and in last follow up each reading will be taken after 15 days of treatment in alternative days. Method of measurement: Modified Ashworth scale will be used to measure the spasticity.</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 Financed</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-17</approval_date>
        <contact_name>Ethical committee of the university of faisalabad</contact_name>
        <contact_address>Sargodha Rd,University Town,Faisalabad,Punjab 38000 Faisalabad punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
