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Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy

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ClinicalTrials.gov Identifier: NCT06029855
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
University of Lahore

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bell Palsy Other: Kabat Therapy Other: Mime Therapy Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects Of Kabat Rehabilitation Versus Mime Therapy On Facial Disability And Synkinesis In Patients Of Bell's Palsy
Actual Study Start Date : May 1, 2023
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : October 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Kabat Therapy
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.
 Other: Kabat Therapy
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.
Experimental: Mime Therapy
Mime therapy utilizes emotional input to access better movement patterns. It is beneficial as it improves circulation and maintains muscle properties.
 Other: Mime Therapy
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Synkinesis [ Time Frame: It will be assessed at baseline, at the third week and at six week. ]
    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.

  2. Level of Facial Disability [ Time Frame: Change in functional status will be measured at the baseline, at 3rd week and at 6th week. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age group 25-50 years.
  2. Both male and female.
  3. Unilateral bell's paralysis.
  4. Not congenital in origin.
  5. Sub-acute and chronic cases.

Exclusion Criteria:

  1. Other neurological deficits include epilepsy and Alzheimer's disease.
  2. Traumatic onset.
  3. Surgical reconstruction (nerve or muscle reconstruction).
  4. Mental and psychological disorders i.e., schizophrenia, bipolar disorders.
  5. Skin diseases (eczema, urticarial) as electrical stimulation may affect the results.
  6. Any contraindications for massage like sunburn, bruising, or cuts.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06029855


Contacts
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Contact: Ayesha Amjad, MS +923054645864 ayeshaamjad056@gmail.com
Contact: Ayesha Jamil, M.Phil +923244481031 ayeshabutt031@gmail.com

Locations
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Pakistan
The University of Lahore Recruiting
Lahore, Punjab, Pakistan, 5400
Contact: Ayesha Amjad, MS    +923054645864    ayeshaamjad056@gmail.com   
Contact: Ayesha Jamil, M.Phil    +923244481031    ayesha.jamil@uipt.uol.edu.pk   
Principal Investigator: Ayesha Amjad, MS         
Sponsors and Collaborators
University of Lahore
Investigators
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Study Chair: Ashfaq Dr Ahmed, PhD The University of Lahore
More Information
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Responsible Party: University of Lahore
ClinicalTrials.gov Identifier: NCT06029855    
Other Study ID Numbers: REC-UOL-406-05-2023
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: Immediately after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Lahore:
Bell Palsy
Kabat Rehabilitation
Mime Therapy
Additional relevant MeSH terms:
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Bell Palsy
Facial Paralysis
Paralysis
Synkinesis
Neurologic Manifestations
Nervous System Diseases
Herpesviridae Infections
DNA Virus Infections
 Virus Diseases
Infections
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Dyskinesias