<?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>IRCT20220522054955N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-23</date_registration>
      <primary_sponsor>king edward medical university</primary_sponsor>
      <public_title>effect of kabat technique vs facial neuromuscular re-education technique to reduce facial disability and synkinesis in bell's palsy patients</public_title>
      <acronym></acronym>
      <scientific_title>effect of kabat technique vs facial neuromuscular re-education technique to reduce facial disability and synkinesis in bell's palsy patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>85</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67865</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: it was a single blinded randomized conrol trial.. all he participants who came o physiotherapy department diagnosed with bells palsy were considered . 70 patients were alotted in two groups via lottery method, Blinding description: in this study participants are blinded for treatment  technique. two different techniques  were provided to patients and they were blind about that which technique is given to which patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bells' palsy patients.</hc_freetext>
      <i_freetext>Intervention 1: Group A will recieve the Kabat technique . Kabat et al. invented it. It is a manual resistance exercise that stimulates fundamental movement patterns, activates proprioceptors, accelerates the neuromuscular mechanism's response, and either promotes facilitation or inhibits it. It also improves flexibility, strength, and coordination.Conventional treatment includes:• Galvanic current interrupted by 100 milliseconds, rectangular waveform, three sets, and three contractions in each set • Facial massage by hand: effleurage, kneading, wringing, hacking, tapping, and stroking from finger to thumb are all forms of exercise.•	For a total of six weeks, intervention was provided twice per week. One session of treatment lasted between 45 and an hour. Intervention 2: Intervention group: Received neuromuscular re-education techniqueThe patient was placed into one of four treatment-based categories—initiation, facilitation, movement control, and relaxation—based on their impairment on the Sunny Brook Facial Grading Scale (SFGS).Conventional treatment includes:• Galvanic current interrupted by 100 milliseconds, rectangular waveform, three sets, and three contractions in each set • Facial massage by hand: effleurage, kneading, wringing, hacking, tapping, and stroking from finger to thumb are all forms of exercise.•	For a total of six weeks, intervention was provided twice per week. One session of treatment lasted between 45 and an hour.</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:
EFFECT OF KABAT TECHNIQUE AND FACIAL NEUROMUSCULAR RE-EDUCATION TECHNIQUE TO REDUCE FACIAL DISABILITY AND SYNKINESIS IN BELLS PALSY PATIENTS

When:
study is completed and become available after its publication

To whom:
person in academic institute.patient data will not be shown

Conditions:
under the usage with terms in which journal is accessed / processed for publication it could be used on request

Where to obtain:
from the university office and responsible supervisor and from journal we will process in future

How to obtain:
can be on call or mail it will be only used in confidential way for improving reseaerch and benifit of humanity

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rabia Rahim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>86-B rehman pura lahore</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 321 4558408</telephone>
        <email>rabiarahim08@ymal.com</email>
        <affiliation>king edward medical university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr muhammad iqbal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>neela gumbad , new anarkali lahore</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>36121</zip>
        <telephone>+92 300 8020301</telephone>
        <email>iqbaldr1069@gmail.com</email>
        <affiliation>king edward medical university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 20-60 years
Diagnosed cases of Bell’s palsy
Non traumatic origin
onset(0-6 months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>a)	Psychiatric patients or non-cooperative patients
Patients complaining of other neurological deficit
Post-surgical cases
Neurotemesise
Upper motor neuron lesion
Any underlying terminal disease</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>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group A will recieve the Kabat technique . Kabat et al. invented it. It is a manual resistance exercise that stimulates fundamental movement patterns, activates proprioceptors, accelerates the neuromuscular mechanism's response, and either promotes facilitation or inhibits it. It also improves flexibility, strength, and coordination.Conventional treatment includes:• Galvanic current interrupted by 100 milliseconds, rectangular waveform, three sets, and three contractions in each set • Facial massage by hand: effleurage, kneading, wringing, hacking, tapping, and stroking from finger to thumb are all forms of exercise.•	For a total of six weeks, intervention was provided twice per week. One session of treatment lasted between 45 and an hour.</i_keyword>
      <i_keyword>Intervention group: Received neuromuscular re-education techniqueThe patient was placed into one of four treatment-based categories—initiation, facilitation, movement control, and relaxation—based on their impairment on the Sunny Brook Facial Grading Scale (SFGS).Conventional treatment includes:• Galvanic current interrupted by 100 milliseconds, rectangular waveform, three sets, and three contractions in each set • Facial massage by hand: effleurage, kneading, wringing, hacking, tapping, and stroking from finger to thumb are all forms of exercise.•	For a total of six weeks, intervention was provided twice per week. One session of treatment lasted between 45 and an hour.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Facial disability. Timepoint: baseline, after three weeks and after 6 weeks. Method of measurement: facial disability index.</prim_outcome>
      <prim_outcome>Synkinesis. Timepoint: baseline,after 3 weeks and after 6 weeks. Method of measurement: sunny brook facial grading score.</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>king edward medical university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-05</approval_date>
        <contact_name>advanced studies and research board</contact_name>
        <contact_address>Neela Gumbad, New anarkali, Lahore lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
