<?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>IRCT20230721058872N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-24</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Effects of Neural Mobilization and PNF for Bell's palsy</public_title>
      <acronym>PNF</acronym>
      <scientific_title>COMPARATIVE EFFECTS OF NEURAL MOBILIZATION AND PROPRIORECEPTIVE NEUROMUSCULAR FACILITATION IN PATIENTS WITH BELL'S PALSY</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72610</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Tools used in randomization such as table of random numbers.  (eg: chit draw by lottary method), Blinding description: single blinded at subject/participant level.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bell's Palsy.</hc_freetext>
      <i_freetext>Intervention group: PNF.</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:
Comaprative Effects of Neural Mobilization and PNF stretching in patients with Bell's Palsy

When:
(staring in september 2023)- (staring 12 months after publication)

To whom:
academics institutions

Conditions:
under the RCT studies

Where to obtain:
https://www.linkedin.com/in/maidah-bashir-6a22621a1/

How to obtain:
https://www.linkedin.com/in/maidah-bashir-6a22621a1/

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>The University Of Faisalabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House No 126, Chambeli Block; The Four Seasons Housing Society - Faisalabad.</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+93 22 781 0920</telephone>
        <email>maidahbashir@gmail.com</email>
        <affiliation>Maidah Bashir</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Marium Zafar; PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Avenue, Faisal Town Canal Road, Faisalabad, Punjab /Dr. Tusi Rd, Faisalabad, Punjab.</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 300 4561972</telephone>
        <email>marium.zafar@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with idiopathic bell’s palsy.
Patient who are at grade 2 (mild dysfunction) and grade 3 (moderate dysfunction) according to House Brakmann scale.
Patients with unilateral bell’s palsy.
People who are ranging from 15 years to 45 years of age.
Patients who are not taking medical treatment for it (For Example NSAIDS or steroids).</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients taking any other treatment for the bell's palsy.
Those who refuse for the consent
Those who have any head injury, trauma, psychological disorders or recent surgery
Those who have any other serious co morbidity like malignancy, tumor and neurogenic shock.
Patients who have autoimmune disorders.
Patients who had recent surgery related to dental, ear, nose or throat.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Facial nerve disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: PNF</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>House Brackmann Scale (HBS) &amp; Facial Disability Index Scale (FDI). Timepoint: Primary Outcome measure was taken at baseline of treatment at 1st week, before giving intervention and than measure at end of three weeks after giving treatment. Method of measurement: primary outcome measurement was taken by analaysis of grade 2, 3 and grade 4 by using House Brackmann scale and Facial Disability Scale by using two dimensions of it that are physical impairement and pschological impairment of Bell's Palsy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>House Brackmann Scale (HBS) and Facial Disability Index Scale (FDI). Timepoint: 3 Weeks. Method of measurement: At end of treatment session of 3 weeks we analysed grades by House Brackmann Scale (HBS) and physcial and social/psychological impairement by Facial Disability Index Scale (FDI).</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>N/A</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-24</approval_date>
        <contact_name>The University Of Faisalabad.</contact_name>
        <contact_address>University Avenue, Faisal Town Canal Road, Faisalabad, Punjab (Pakistan) Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
