<?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>IRCT20200909048676N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-24</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>EFFECTS OF 8 WEEKS FUNCTIONAL TRAINING PROGRAM IN POSTURE CONTROL AND FUNCTIONAL MOBILITY IN SPASTIC HEMIPLEGIC CEREBERAL PALSY</public_title>
      <acronym></acronym>
      <scientific_title>EFFECTS OF 8 WEEKS FUNCTIONAL TRAINING PROGRAM IN POSTURE CONTROL AND FUNCTIONAL MOBILITY IN SPASTIC HEMIPLEGIC CEREBERAL PALSY</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>14</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50920</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Non probability convenient sampling will be used to recruit the individuals for the study. Randomization will be done by lottery method to divide the individuals to 2 treatment groups. sealed envelop will be used for allocation concealment, Randomization description: Randomization by lottery method. Allocation concealment through sealed envelope, Blinding description: Participants will be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Spastic Hemiplegic Cerebral Palsy.</hc_freetext>
      <i_freetext>Intervention 1: Subjects will receive 8 weeks treatment 3 times a week. session will be of 45 mints to 1 hour. Group A will receive conventional training program consist on TENS, hot pack, ROMs, stretching, bridging , balance training, supine to sit exercise, diagonal pattern ex with resistance, lateral walk, step ups, gait training, sit to stand, stair climbing, single leg standing, weight shift, cat position. Intervention 2: Intervention group: Subjects will receive 8 weeks treatment 3 times a week. session will be of 45 mints to 1 hour. Group B will receive functional training program consist on Gym ball exercises, ex with resistance bands, unilateral pelvic bridging, Bosu ball ex , trampoline jumping, resistance kneeling, Treadmill walk, squats, cycling, cat walk, back walk, stepper ex, stair climbing.</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 there is no further decision and information decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aeysha Gulzar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madar-e-Millat Road, Quaid-e-Azam Industrial Estate</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54770</zip>
        <telephone>+92 42 35126110</telephone>
        <email>ash.gul2012@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aeysha Gulzar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madar-e-Millat Road, Quaid-e-Azam Industrial Estate</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54770</zip>
        <telephone>+92 42 35126110</telephone>
        <email>ash.gul2012@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children diagnosed with cerebral palsy
Ages between 4 to 14 years
Children with gross motor functional classification system (GMFCS) level II or lll
Children with no mental retardation
The degree of spasticity according to Modified Ashworth Scale ranged between grade 1 to 3</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>14 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children who have had orthopedic surgery or Botulinum toxin injection
Children with severe visual defect
Children having auditory impairment
Children having vestibular problem
Children with severe perceptual deficit.
Parents of children who don't want to participate in study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G80.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spastic hemiplegic 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>Subjects will receive 8 weeks treatment 3 times a week. session will be of 45 mints to 1 hour. Group A will receive conventional training program consist on TENS, hot pack, ROMs, stretching, bridging , balance training, supine to sit exercise, diagonal pattern ex with resistance, lateral walk, step ups, gait training, sit to stand, stair climbing, single leg standing, weight shift, cat position</i_keyword>
      <i_keyword>Intervention group: Subjects will receive 8 weeks treatment 3 times a week. session will be of 45 mints to 1 hour. Group B will receive functional training program consist on Gym ball exercises, ex with resistance bands, unilateral pelvic bridging, Bosu ball ex , trampoline jumping, resistance kneeling, Treadmill walk, squats, cycling, cat walk, back walk, stepper ex, stair climbing</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postural control and functional mobility. Timepoint: Total 8 week program and no follow up. Primary outcome will be measured on 8th week. Method of measurement: Pediatric Balance scale, Trunk control measurement scale, Five Times Sit to Stand Test , Timed Up and Go.</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>Riphah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-01</approval_date>
        <contact_name>Ethics committee of Riphah College of Rehabilitation &amp; Allied health Sciences</contact_name>
        <contact_address>Madar-e-Millat Road, Quaid-e-Azam Industrial Estate. Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
