<?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>IRCT20240726062547N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-10-01</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Cranial Nerve Seventh (VII) Mobilization versus Manual Manipulation of facial muscles for Bell’s palsy patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effectiveness of Cranial Nerve Seventh (VII) Mobilization versus Manual Manipulation of facial muscles for improving muscular movement and Synkinesis among Bell’s palsy patients; Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78220</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: A clinical trial to find out better effective treatment protocol for bell's palsy patients, Randomization description: A computer software called Online randomize generator was used. the software generated a random sequence. Allocation concealment was carried out, Blinding description: Participants were blinded in the study as they did not know which group were they being allocated to. Group allocation sequence was selected by a computer software called online randomize generator.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bell's palsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Manual Manipulation of facial muscles group. Intervention 2: Intervention group: Cranial Nerve seventh (VII) Mobilization group.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aleena Shabbir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gulistan colony no.1 W.E block house no.5, Faisalabad, Pakistan</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38610</zip>
        <telephone>+92 41 8750971</telephone>
        <email>aleena.shabbir06@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haniya Imran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Saeed Colony # 2, Yasir Street, House#p47, Faisalabad, Punjab, Pakistan</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 341 4812191</telephone>
        <email>Haniyaimran118@gmail.com</email>
        <affiliation>The University Of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Acute stage (onset within first week).
House Brackmann grading scale score gradeⅡ-Ⅲ (mild to moderate).
Sunny Brook facial grading scale score ≥40 (mild to moderate).
Diagnosed unilateral Bell’s palsy by clinical and neurological assessment.
No previous history of Bell’s palsy and stroke.
Diagnosed Bell’s palsy pt receiving standard drug treatment (SDT).
No previous History of physiotherapy treatment sessions for Bell’s palsy.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diagnosed Neurodegenerative Disorders (Multiple sclerosis, Myasthenia gravis and Guillain-Barre syndrome).
Diagnosed intra cranial Tumors(55), parotid gland tumors(56),facial nerve schwannomas (56)and squamous cell carcinoma.
Diagnosed Viral infection (herpes simplex, herpes zoster).
Diagnosed for more than 14 days.
Multiple episodes (more than 1) of Bell’s palsy.
Presence of severe comorbidities (diabetes, hypertension) that could impact the implementation of the treatment and performance.
Diagnosed Traumatic injury to the 7th cranial nerve.
Pacemakers or implanted electrical devices.
Unwilling to participate in the study.</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: Manual Manipulation of facial muscles group</i_keyword>
      <i_keyword>Intervention group: Cranial Nerve seventh (VII) Mobilization group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Voluntary movement. Timepoint: Before intervention and after 15th session. Method of measurement: House-Brackmann grading scale.</prim_outcome>
      <prim_outcome>Synkinesis. Timepoint: Before intervention and after 15th session. Method of measurement: Sunny Brook Facial Grading Scale.</prim_outcome>
      <prim_outcome>Facial expressions. Timepoint: Before intervention and after 15th session. Method of measurement: Sunny Brook Facial Grading Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Symmetry of face. Timepoint: Before intervention and after 15th session. Method of measurement: Sunnybrook Facial Grading Scale.</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 Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-08-13</approval_date>
        <contact_name>Ethical Institutional Review Board</contact_name>
        <contact_address>Gulistan colony no.1,  W.E block, House no.5, Faisalabad, Pakistan Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
