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/NCT06028191</url>
    </required_header>
    <id_info>
      <org_study_id>REC/RCR &amp; AHS/23/0229</org_study_id>
      <nct_id>NCT06028191</nct_id>
    </id_info>
    <brief_title>Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy</brief_title>
    <official_title>Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</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>
        The objective of this current study is to determine the combined effects of Low-Level Laser&#xD;
        Therapy (LLLT) and the Kabat technique on quality of life, synkinetic movements and&#xD;
        functional outcome in patients of Bell's palsy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Bell's palsy is an acute condition which occurs by the damage of 7th cranial nerve along its&#xD;
        course at the level which is distal to Pons. Basically it is an idiopathic facial condition.&#xD;
  &#xD;
        The yearly incidence of Bell's palsy is 15 to 30 per 100,000 people, which affect both sexes&#xD;
        equally. This study aims to see combined effects of Low Level Laser Therapy and Kabat&#xD;
        technique in the treatment of Bell's palsy.&#xD;
  &#xD;
        Synkinesis, which is described as an involuntary movement in one part of the face produced&#xD;
        during voluntary movement in another region of the face, is a problematic Bell's palsy&#xD;
        sequel. The mechanism behind the formation of synkinesis is unknown. According to the&#xD;
        predominant idea, damaged axons regenerate abnormally, innervating facial muscles that&#xD;
        weren't originally innervated. The yearly incidence of Bell's palsy is 15 to 30 per 100,000&#xD;
        people, which affect both sexes equally.&#xD;
  &#xD;
        Kabat Technique is neurorehabilitation technique that uses diagonal and spiral patterns for&#xD;
        movement in conjunction with stretch and resistance and other PNF techniques to reinforce&#xD;
        neuromuscular recruitment. It mainly concerns the stimulation of these muscles: Orbicularis&#xD;
        occuli, ztgomaticus, Levator labii, nasalis, buccinator, frontalis, corrugator.&#xD;
  &#xD;
        For all BP patients, including those who are unable to take corticosteroids due to diabetes&#xD;
        or hypertension, laser therapy offers a non-invasive, painless means of treatment. However,&#xD;
        just a few researches have examined the effectiveness of low- dose laser therapy in BP&#xD;
        patients.&#xD;
  &#xD;
        Low Level Laser Therapy has the potential to promote nerve regeneration, reduce inflammation,&#xD;
        and accelerate tissue healing in the affected facial nerve. On the other hand, the Kabat&#xD;
        technique focuses on restoring neuromuscular control and improving muscle function. By&#xD;
        combining Low Level Laser Therapy and the Kabat technique, a synergistic effect may be&#xD;
        achieved, maximizing the potential benefits of both interventions. Therefore, this study aims&#xD;
        to determine the specific parameters and protocols for the combined use of Low Level Laser&#xD;
        Therapy and the Kabat technique in Bell's palsy&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 17, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">October 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>Sunnybrook Facial Grading system</measure>
      <time_frame>6 weeks</time_frame>
      <description>Sunnybrook facial grading system was used to quantify the symmetry of voluntary and resting muscles</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Facial disability index</measure>
      <time_frame>6 weeks</time_frame>
      <description>it has two components. The physical function subscale detects problems in drinking, speaking eating, lacrimation, and oral hygiene. The social/well-being function subscale detects subjective irritation, perception of anxiety, and isolation; problems in sleeping; and limitations in social participation.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Bell Palsy</condition>
    <arm_group>
      <arm_group_label>Kabat Technique along with baseline treatment</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Kabat technique will be performed for 15 min along with baseline treatment will be given to Group A. They will have 45 min-1 hour session thrice a week in duration of six weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Kabat Technique and LLLT along with baseline treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Kabat technique will be performed for 15 min and LLLT will be performed for 10 min to eight points of the effected side for 2 min at each point along with baseline treatment. They will have 45 min-1 hour session thrice a week in duration of six weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Kabat Technique along with baseline treatment</intervention_name>
      <description>Group A will receive Kabat Technique along with baseline treatment. Electrical muscle stimulation for 15 min which includes faradic current to the facial nerve trunks given by DL-2 electro pulse stimulator, Effleurage and Kneading for 5 min and resistive exercise for 5 min and facial expression exercises for 5 min, which included eye closure, eyebrow raise, frown, smile, snarl, pucker and pout as baseline treatment.&#xD;
  Kabat Technique is neurorehabilitation technique that uses diagonal and spiralpatterns for movement in conjunction with stretch and resistance and other PNF techniques to reinforce neuromuscular recruitment. It mainly concerns the stimulation of these muscles: Orbicularis occuli, ztgomaticus, Levator labii, nasalis, buccinator, frontalis, corrugator</description>
      <arm_group_label>Kabat Technique along with baseline treatment</arm_group_label>
      <other_name>Group A</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Kabat Technique and LLLT along with baseline treatment</intervention_name>
      <description>Group B will receive Kabat Technique and LLLT along with baselinetreatment. Kabat technique is same as mentioned in group A. Laser treatment will be administered to eight points of the affected side for 2 min at each point at a wavelength of 830 nm, output power of 100 Mw, and frequency of 1 KHz. Endo laser 422 is the model name and number of device which will be used in this study to administered low level laser therapy.</description>
      <arm_group_label>Kabat Technique and LLLT along with baseline treatment</arm_group_label>
      <other_name>Group B</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-40&#xD;
  &#xD;
            -  Both genders will be included&#xD;
  &#xD;
            -  Unilateral Facial paralysis/paresis&#xD;
  &#xD;
            -  Patients presented within onset of 12 days - 3 weeks (sub-acute Bell's Palsy)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous surgery of facial reconstruction&#xD;
  &#xD;
            -  Traumatic Brain Injury&#xD;
  &#xD;
            -  Any other neurological deficit&#xD;
  &#xD;
            -  Congenital Deformities&#xD;
  &#xD;
            -  Recurrent Bell's palsy will be excluded&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fatima Tariq, Mphil</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fatima Tariq, Mphil</last_name>
      <phone>03344255033</phone>
      <email>fatima.tariq@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Allied Hospital</name>
        <address>
          <city>Faisalābad</city>
          <state>Punjab</state>
          <zip>38000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fatima Tariq, Mphil</last_name>
        <phone>03344255033</phone>
        <email>fatima.tariq@riphah.edu.pk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Physiofit</name>
        <address>
          <city>Faisalābad</city>
          <state>Punjab</state>
          <zip>38000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fatima Tariq, Mphi;</last_name>
        <phone>03344255033</phone>
        <email>fatima.tariq@riphah.edu.pk</email>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Bell's Palsy</keyword>
    <keyword>Facial Disability Index</keyword>
    <keyword>Kabat Technique</keyword>
    <keyword>Low Level Laser Therapy</keyword>
    <keyword>Sunnybrook facial grading system</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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06028191
  org study id: REC/RCR & AHS/23/0229
  nct id: NCT06028191
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this current study is to determine the combined effects of Low-Level Laser
        Therapy (LLLT) and the Kabat technique on quality of life, synkinetic movements and
        functional outcome in patients of Bell's palsy
  Bell's palsy is an acute condition which occurs by the damage of 7th cranial nerve along its
        course at the level which is distal to Pons. Basically it is an idiopathic facial condition.
  
        The yearly incidence of Bell's palsy is 15 to 30 per 100,000 people, which affect both sexes
        equally. This study aims to see combined effects of Low Level Laser Therapy and Kabat
        technique in the treatment of Bell's palsy.
  
        Synkinesis, which is described as an involuntary movement in one part of the face produced
        during voluntary movement in another region of the face, is a problematic Bell's palsy
        sequel. The mechanism behind the formation of synkinesis is unknown. According to the
        predominant idea, damaged axons regenerate abnormally, innervating facial muscles that
        weren't originally innervated. The yearly incidence of Bell's palsy is 15 to 30 per 100,000
        people, which affect both sexes equally.
  
        Kabat Technique is neurorehabilitation technique that uses diagonal and spiral patterns for
        movement in conjunction with stretch and resistance and other PNF techniques to reinforce
        neuromuscular recruitment. It mainly concerns the stimulation of these muscles: Orbicularis
        occuli, ztgomaticus, Levator labii, nasalis, buccinator, frontalis, corrugator.
  
        For all BP patients, including those who are unable to take corticosteroids due to diabetes
        or hypertension, laser therapy offers a non-invasive, painless means of treatment. However,
        just a few researches have examined the effectiveness of low- dose laser therapy in BP
        patients.
  
        Low Level Laser Therapy has the potential to promote nerve regeneration, reduce inflammation,
        and accelerate tissue healing in the affected facial nerve. On the other hand, the Kabat
        technique focuses on restoring neuromuscular control and improving muscle function. By
        combining Low Level Laser Therapy and the Kabat technique, a synergistic effect may be
        achieved, maximizing the potential benefits of both interventions. Therefore, this study aims
        to determine the specific parameters and protocols for the combined use of Low Level Laser
        Therapy and the Kabat technique in Bell's palsy
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Sunnybrook Facial Grading system
  time frame: 6 weeks
  description: Sunnybrook facial grading system was used to quantify the symmetry of voluntary and resting muscles
  measure: Facial disability index
  time frame: 6 weeks
  description: it has two components. The physical function subscale detects problems in drinking, speaking eating, lacrimation, and oral hygiene. The social/well-being function subscale detects subjective irritation, perception of anxiety, and isolation; problems in sleeping; and limitations in social participation.
  arm group label: Kabat Technique along with baseline treatment
  arm group type: Other
  description: Kabat technique will be performed for 15 min along with baseline treatment will be given to Group A. They will have 45 min-1 hour session thrice a week in duration of six weeks.
  arm group label: Kabat Technique and LLLT along with baseline treatment
  arm group type: Experimental
  description: Kabat technique will be performed for 15 min and LLLT will be performed for 10 min to eight points of the effected side for 2 min at each point along with baseline treatment. They will have 45 min-1 hour session thrice a week in duration of six weeks
  intervention type: Other
  intervention name: Kabat Technique along with baseline treatment
  description: Group A will receive Kabat Technique along with baseline treatment. Electrical muscle stimulation for 15 min which includes faradic current to the facial nerve trunks given by DL-2 electro pulse stimulator, Effleurage and Kneading for 5 min and resistive exercise for 5 min and facial expression exercises for 5 min, which included eye closure, eyebrow raise, frown, smile, snarl, pucker and pout as baseline treatment.
  Kabat Technique is neurorehabilitation technique that uses diagonal and spiralpatterns for movement in conjunction with stretch and resistance and other PNF techniques to reinforce neuromuscular recruitment. It mainly concerns the stimulation of these muscles: Orbicularis occuli, ztgomaticus, Levator labii, nasalis, buccinator, frontalis, corrugator
  arm group label: Kabat Technique along with baseline treatment
  other name: Group A
  intervention type: Device
  intervention name: Kabat Technique and LLLT along with baseline treatment
  description: Group B will receive Kabat Technique and LLLT along with baselinetreatment. Kabat technique is same as mentioned in group A. Laser treatment will be administered to eight points of the affected side for 2 min at each point at a wavelength of 830 nm, output power of 100 Mw, and frequency of 1 KHz. Endo laser 422 is the model name and number of device which will be used in this study to administered low level laser therapy.
  arm group label: Kabat Technique and LLLT along with baseline treatment
  other name: Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Fatima Tariq, Mphil
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Fatima Tariq, Mphil
  phone: 03344255033
  email: fatima.tariq@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Pakistan
  responsible party type: Sponsor
  mesh term: Bell Palsy
  mesh term: Facial Paralysis
  mesh term: Paralysis
  sharing ipd: No