<?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>IRCT20210816052201N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-16</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Proprioceptive neuromuscular facilitation with mime therapy and sensory exercises in patients with bell's palsy</public_title>
      <acronym>Proprioceptive neuromuscular facilitation</acronym>
      <scientific_title>PNF with mime therapy and sensory exercises in patients with bell's palsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79206</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A computer-operated random approach will be used to divide the subjects into two groups. Recruitment will be done for patients with Bell’s Palsy between the ages of 20 and 45, Blinding description: This is going to be a single blinded study and the outcome assessor will be blind. Assessor will independently collect the data through outcome measures from the patient of group A and B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bell’s palsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:PNF, Mime Therapy and Sensory Exercises. 3 sessions of 40 minutes will be given to the patient per week for 18 weeks (1.5 months). The baseline readings will be taken initially, second reading will be taken on 4th week. Follow up reading will be taken on 6th week. In the treatment session EMS will be applied for 10 minutes, PNF will be applied for 15 minutes along with stretching, Mime therapy will be applied for 10 minutes and sensory exercises will be performed with 5 repetitions each for 10 minutes. Intervention 2: Control group: PNF   3 sessions of 40 minutes will be given to the patient per week for 18 weeks (1.5 months). The baseline readings will be taken initially, second reading will be taken on 4th week. Follow up reading will be taken on 6th week. In the treatment session EMS will be applied for 10 minutes, PNF will be applied for 15 minutes along with stretching and strengthening exercises will be performed for 10 minutes.</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:
PNF WITH MIME THERAPY AND SENSORY EXCERCISE INPATIENTS WITH BELL'S PALSY

When:
data will be available after completion of treatment session. That will be march 2025

To whom:
data will be visible to academic institutions

Conditions:
another author of our study is also available for reviewing request
author: ayeshabutt031@gmail.com

Where to obtain:
kindly contact responsible persons of this study
1st Author: ahmadayesha460@gmail.com
corresponding author: sana.akram@uipt.uol.edu.pk

How to obtain:
contact to above mentioned person that will provide you as early as posssible

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ayesha Ahmad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University of Lahore, Defence Road Lahore ,Pakistan.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35183083</telephone>
        <email>ayesha.ahmad@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore, Lahore Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sana Akram</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University of Lahore, Defence Road Lahore ,Pakistan.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35183083</telephone>
        <email>sana.akram@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore, Lahore Pakistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 20-45 years
Both the genders
Acute cases Bell’s palsy (1-3 weeks)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dental metal prosthesis
Participants with cognitive disorders
Subject with surgery for ear &amp; facial nerve palsy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G51.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bell's 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>Intervention group:PNF, Mime Therapy and Sensory Exercises. 3 sessions of 40 minutes will be given to the patient per week for 18 weeks (1.5 months). The baseline readings will be taken initially, second reading will be taken on 4th week. Follow up reading will be taken on 6th week. In the treatment session EMS will be applied for 10 minutes, PNF will be applied for 15 minutes along with stretching, Mime therapy will be applied for 10 minutes and sensory exercises will be performed with 5 repetitions each for 10 minutes.</i_keyword>
      <i_keyword>Control group: PNF   3 sessions of 40 minutes will be given to the patient per week for 18 weeks (1.5 months). The baseline readings will be taken initially, second reading will be taken on 4th week. Follow up reading will be taken on 6th week. In the treatment session EMS will be applied for 10 minutes, PNF will be applied for 15 minutes along with stretching and strengthening exercises will be performed for 10 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The facial symmetry will be assessed by Sunnybrooke Facial Grading System. The system includes three components: (1) resting symmetry, (2) the symmetry of voluntary movements, and (3) synkinesis. The SFGS has high reliability and repeatability which is good to excellent. Timepoint: The baseline readings will be taken initially, second reading will be taken in 4th week and the follow up reading will be taken in the 6th week. Method of measurement: Functional disability measured by Facial Clinimetric Evaluation Scale (FaCE)                                   Facial symmetry is assessed by Sunnybrooke Facial Grading System.</prim_outcome>
      <prim_outcome>The Facial Clinimetric Evaluation Scale (FaCE) is a validated patient-based facial grading instrument developed in 2001. It measures both impairment and disability in facial paralysis and has the potential to be an invaluable adjunct to physician-graded scales. The FaCE scale is a 15-item (questions),five-point Likert scale that consists of six domains. The domains are facial movement, facial comfort, oral function, eye comfort, lacrimal control and social function. Transformed total and domain scores are calculated using specific formulas and the scores obtained range from 0 to 100. Timepoint: The baseline readings will be taken initially, second reading will be taken in 4th week and the follow up reading will be taken in the 6th week. Method of measurement: Functional disability measured by Facial Clinimetric Evaluation Scale (FaCE)                                   Facial symmetry is assessed by Sunnybrooke Facial Grading System.</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-08-13</approval_date>
        <contact_name>Research Ethics Committee</contact_name>
        <contact_address>The University of Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
