xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06029855</url>
    </required_header>
    <id_info>
      <org_study_id>REC-UOL-406-05-2023</org_study_id>
      <nct_id>NCT06029855</nct_id>
    </id_info>
    <brief_title>Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy</brief_title>
    <official_title>Effects Of Kabat Rehabilitation Versus Mime Therapy On Facial Disability And Synkinesis In Patients Of Bell's Palsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Lahore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Lahore</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Bell's palsy, also called idiopathic facial paralysis, is a common cause of unilateral facial&#xD;
        paralysis. It is one of the most common neurological disorders of the cranial nerves.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Bell's palsy is an alarming condition of rapid onset, which paralyzes half of the facial&#xD;
        muscles. Kabat rehabilitation is a manual resistance technique that promotes a basic pattern&#xD;
        of movement through facilitation, inhibition, and resistance of a group of muscles. It&#xD;
        increases the functioning and power of facial muscles while Mime therapy results in immediate&#xD;
        improvement of function and integrity of facial muscles. It also mitigates synkinesis in&#xD;
        Bell's palsy. Both techniques are easy to apply. They are clinically important techniques&#xD;
        that are easily understood by patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Synkinesis</measure>
      <time_frame>It will be assessed at baseline, at the third week and at six week.</time_frame>
      <description>Synkinesis will be accessed through the &quot;House-Brackmann Scale&quot;. It is classified as a universal scale. This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face. It is divided into six categories (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) and is a 0-6-point scale with 6 representing total paralysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Level of Facial Disability</measure>
      <time_frame>Change in functional status will be measured at the baseline, at 3rd week and at 6th week.</time_frame>
      <description>The level of Facial disability will be measured through the &quot;Facial Disability Index Scale&quot;. This scale has ten items that evaluate the patient's physical and social aspects (mastication, deglutition, communication, labial mobility, emotional alterations, and social integration). It uses a hundred-point scale with a higher score indicating less impairment. 24 Minimum score for physical functioning: 0, Maximum score for physical functioning: 25, Minimum score for social and well-being: 5, Maximum score for social and well-being.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">85</enrollment>
    <condition>Bell Palsy</condition>
    <arm_group>
      <arm_group_label>Kabat Therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Kabat exercises primarily assist functional response in defective muscles through the general structure of muscles experiencing resistance. After 6th week, resting and voluntary symmetries were recorded.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mime Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Mime therapy utilizes emotional input to access better movement patterns. It is beneficial as it improves circulation and maintains muscle properties.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Kabat Therapy</intervention_name>
      <description>The participants of group A will receive Kabat Rehabilitation with routine physical therapy. The protocol will be given to the participants for three sessions/week for six weeks. Each session will be of 30 minutes.</description>
      <arm_group_label>Kabat Therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mime Therapy</intervention_name>
      <description>The participants of group B will receive Mime Therapy in addition to routine physical therapy. The protocol will be given to the participants once a week for six weeks, while physical therapy will be given on alternate days. Each session will be of 30 minutes.</description>
      <arm_group_label>Mime Therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age group 25-50 years.&#xD;
  &#xD;
            2. Both male and female.&#xD;
  &#xD;
            3. Unilateral bell's paralysis.&#xD;
  &#xD;
            4. Not congenital in origin.&#xD;
  &#xD;
            5. Sub-acute and chronic cases.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Other neurological deficits include epilepsy and Alzheimer's disease.&#xD;
  &#xD;
            2. Traumatic onset.&#xD;
  &#xD;
            3. Surgical reconstruction (nerve or muscle reconstruction).&#xD;
  &#xD;
            4. Mental and psychological disorders i.e., schizophrenia, bipolar disorders.&#xD;
  &#xD;
            5. Skin diseases (eczema, urticarial) as electrical stimulation may affect the results.&#xD;
  &#xD;
            6. Any contraindications for massage like sunburn, bruising, or cuts.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ashfaq Dr Ahmed, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>The University of Lahore</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ayesha Amjad, MS</last_name>
      <phone>+923054645864</phone>
      <email>ayeshaamjad056@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ayesha Jamil, M.Phil</last_name>
      <phone>+923244481031</phone>
      <email>ayeshabutt031@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Lahore</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>5400</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ayesha Amjad, MS</last_name>
        <phone>+923054645864</phone>
        <email>ayeshaamjad056@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Ayesha Jamil, M.Phil</last_name>
        <phone>+923244481031</phone>
        <email>ayesha.jamil@uipt.uol.edu.pk</email>
      </contact_backup>
      <investigator>
        <last_name>Ayesha Amjad, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Bell Palsy</keyword>
    <keyword>Kabat Rehabilitation</keyword>
    <keyword>Mime Therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bell Palsy</mesh_term>
      <mesh_term>Facial Paralysis</mesh_term>
      <mesh_term>Paralysis</mesh_term>
      <mesh_term>Synkinesis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Immediately after publication</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06029855
  org study id: REC-UOL-406-05-2023
  nct id: NCT06029855
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Bell's palsy, also called idiopathic facial paralysis, is a common cause of unilateral facial
        paralysis. It is one of the most common neurological disorders of the cranial nerves.
  Bell's palsy is an alarming condition of rapid onset, which paralyzes half of the facial
        muscles. Kabat rehabilitation is a manual resistance technique that promotes a basic pattern
        of movement through facilitation, inhibition, and resistance of a group of muscles. It
        increases the functioning and power of facial muscles while Mime therapy results in immediate
        improvement of function and integrity of facial muscles. It also mitigates synkinesis in
        Bell's palsy. Both techniques are easy to apply. They are clinically important techniques
        that are easily understood by patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Change in Synkinesis
  time frame: It will be assessed at baseline, at the third week and at six week.
  description: Synkinesis will be accessed through the "House-Brackmann Scale". It is classified as a universal scale. This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face. It is divided into six categories (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) and is a 0-6-point scale with 6 representing total paralysis.
  measure: Level of Facial Disability
  time frame: Change in functional status will be measured at the baseline, at 3rd week and at 6th week.
  description: The level of Facial disability will be measured through the "Facial Disability Index Scale". This scale has ten items that evaluate the patient's physical and social aspects (mastication, deglutition, communication, labial mobility, emotional alterations, and social integration). It uses a hundred-point scale with a higher score indicating less impairment. 24 Minimum score for physical functioning: 0, Maximum score for physical functioning: 25, Minimum score for social and well-being: 5, Maximum score for social and well-being.
  arm group label: Kabat Therapy
  arm group type: Active Comparator
  description: Kabat exercises primarily assist functional response in defective muscles through the general structure of muscles experiencing resistance. After 6th week, resting and voluntary symmetries were recorded.
  arm group label: Mime Therapy
  arm group type: Experimental
  description: Mime therapy utilizes emotional input to access better movement patterns. It is beneficial as it improves circulation and maintains muscle properties.
  intervention type: Other
  intervention name: Kabat Therapy
  description: The participants of group A will receive Kabat Rehabilitation with routine physical therapy. The protocol will be given to the participants for three sessions/week for six weeks. Each session will be of 30 minutes.
  arm group label: Kabat Therapy
  intervention type: Other
  intervention name: Mime Therapy
  description: The participants of group B will receive Mime Therapy in addition to routine physical therapy. The protocol will be given to the participants once a week for six weeks, while physical therapy will be given on alternate days. Each session will be of 30 minutes.
  arm group label: Mime Therapy
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Ashfaq Dr Ahmed, PhD
  role: Study Chair
  affiliation: The University of Lahore
  last name: Ayesha Amjad, MS
  phone: +923054645864
  email: ayeshaamjad056@gmail.com
  last name: Ayesha Jamil, M.Phil
  phone: +923244481031
  email: ayeshabutt031@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Bell Palsy
  mesh term: Facial Paralysis
  mesh term: Paralysis
  mesh term: Synkinesis
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd time frame: Immediately after publication