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Kabat Rehabilitation Technique Versus Conventional Physical Therapy in Treatment of Bell's Palsy

Primary Purpose

Bell's Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
kabat technique for rehabilitation of facial palsy
electrotherapy
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell's Palsy focused on measuring rehabilitation facial palsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Clinical diagnosis acute unilateral Bell's palsy. Exclusion Criteria: Any concurrent acute ischemia either cardiovascular or cerebrovascular disease. Diabetic patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    traditional technique of facial exercises along with electrical stimulation of facial muscles.

    Kabat technique arm along with stimulation of facial muscles.

    Arm Description

    facial muscle exercise active exercises will be initiated, which is performed in front of a mirror in sitting position. The patient will be instructed for activities like blowing air in the mouth, nasal flaring, smiling, raising and frowning of the eyebrows, opening and closing of the eye, clenching of the teeth and holding straw in mouth, suck and blow out air, show as if blowing a balloon for 20 minutes each session, for 3 sessions/ week for 6 weeks.

    During the Kabat rehabilitation session, the patients will perform specific diagonal and spiral movements, involving the following three muscle fulcrums: Upper fulcrum: includes the frontalis, corrugator & orbicularis oculi muscles. Intermediate fulcrum: includes the common elevator muscle of the upper lip and nasalis. Lower fulcrum: includes the risorius, zygomaticus major, the orbicularis oris and buccinator. (Khanzada et al., 2018). The manipulation of these three fulcra will be carried out by utilizing contralateral contraction and the basic proprioceptive stimulation comprising stretching, maximal resistance, manual contact and verbal input. Kabat sessions will be 3 sessions / week for 6 weeks.

    Outcomes

    Primary Outcome Measures

    facial nerve ultrasonography
    Thickness of facial nerve measured at the thickest part (measured by millimeters)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 23, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Minia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06083389
    Brief Title
    Kabat Rehabilitation Technique Versus Conventional Physical Therapy in Treatment of Bell's Palsy
    Official Title
    The Role of Kabat Rehabilitation Technique Versus Conventional Physical Therapy Along With Electrical Stimulation in Treatment of Bell's Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Minia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate the comparative effectiveness of the Kabat rehabilitation technique with conventional physical therapy along with electrical stimulation in both, for reducing facial disability in patients with Bell's palsy. To assess the prognosis of patients with Bell's palsy, using the assay of serum level of ischemia-modified albumin, high-frequency ultrasonography (HFUS), and electrophysiological studies of the facial nerve.
    Detailed Description
    Bell's Palsy (BP), named after the Scottish anatomist and surgeon Sir Charles Bell who first described it, is a disease that occurs as a result of idiopathic usually unilateral, and isolated seventh cranial nerve (facial nerve) paralysis, leading to an inability to control the facial muscles on the affected side without a known cause . Bell's Palsy is the most common acute mononeuropathy, accounting for approximately 60%-75% of all cases of unilateral facial paralysis . The incidence of BP ranges from 11.5 to 40.2 in 100,000 cases. Although it may influence all ages, it is more commonly seen between 15 and 45 years old . The imbalance between pro-oxidants and antioxidants, if not deactivated by the cellular antioxidant system, results in oxidative stress status. Reactive oxygen species (ROS) derived from ischaemic events can generate products leading to cellular deregulation. Excess of these species can react with cellular macromolecules and results in lipid peroxidation, nucleic acid damages and protein modifications . Systemic markers of oxidative stress include ischemia-modified albumin (IMA). When tissue ischemia occurs, a newly formed albumin called IMA is produced. It is suggested that BP patients have higher serum levels of IMA due to excess ROS and so oxidative stress status providing information about the relationship between oxidative stress status and BP . Electro neurophysiology is the main diagnostic and prognostic tool in peripheral neuropathy. Facial nerve electrodiagnostic is a well-established and important tool for decision-making in patients with facial nerve diseases. Electro neurophysiological analyses of the facial nerve and facial muscles can assist in diagnosis, assess the lesion severity, and it is a valuable tool for predicting recovery. Ultrasonography has increasingly been used to investigate neuromuscular disorders. It enables real-time imaging acquisition, is easily accessible, and can be used at the bedside. Furthermore, it can be used to diagnose and predict prognosis in neuromuscular disorders, as well as to assess structural lesions in nerves. With advances in image resolution, some cranial nerves, including the facial nerve, have also become accessible to ultrasonographic imaging. Neuromuscular ultrasound may be helpful in the diagnosis and disease prognosis. Serial ultrasonographic scanning of the facial nerve from disease onset until recovery may also help advance this promising technique. Bell's palsy is commonly treated by various physical therapy strategies. Physiotherapy treatment for Bell's palsy includes kinesiotherapy, massage therapy, cryotherapy and electrotherapy. Electrical stimulation (ES) of paralyzed muscles has long been a popular intervention for patients with Bell palsy. Kabat rehabilitation is a type of motor control rehabilitation technique based on proprioceptive neuromuscular facilitation. Kabat technique with electrical stimulation of facial muscle is suggested to be effective in improving facial function and reducing facial disability after Bell's palsy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bell's Palsy
    Keywords
    rehabilitation facial palsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    traditional technique of facial exercises along with electrical stimulation of facial muscles.
    Arm Type
    Active Comparator
    Arm Description
    facial muscle exercise active exercises will be initiated, which is performed in front of a mirror in sitting position. The patient will be instructed for activities like blowing air in the mouth, nasal flaring, smiling, raising and frowning of the eyebrows, opening and closing of the eye, clenching of the teeth and holding straw in mouth, suck and blow out air, show as if blowing a balloon for 20 minutes each session, for 3 sessions/ week for 6 weeks.
    Arm Title
    Kabat technique arm along with stimulation of facial muscles.
    Arm Type
    Active Comparator
    Arm Description
    During the Kabat rehabilitation session, the patients will perform specific diagonal and spiral movements, involving the following three muscle fulcrums: Upper fulcrum: includes the frontalis, corrugator & orbicularis oculi muscles. Intermediate fulcrum: includes the common elevator muscle of the upper lip and nasalis. Lower fulcrum: includes the risorius, zygomaticus major, the orbicularis oris and buccinator. (Khanzada et al., 2018). The manipulation of these three fulcra will be carried out by utilizing contralateral contraction and the basic proprioceptive stimulation comprising stretching, maximal resistance, manual contact and verbal input. Kabat sessions will be 3 sessions / week for 6 weeks.
    Intervention Type
    Behavioral
    Intervention Name(s)
    kabat technique for rehabilitation of facial palsy
    Intervention Description
    To evaluate the comparative effectiveness of the Kabat rehabilitation technique with conventional physical therapy along with electrical stimulation in both, for reducing facial disability in patients with Bell's palsy.
    Intervention Type
    Device
    Intervention Name(s)
    electrotherapy
    Intervention Description
    electrical stimulation of facial nerve supplied muscles.3 sessions per week.
    Primary Outcome Measure Information:
    Title
    facial nerve ultrasonography
    Description
    Thickness of facial nerve measured at the thickest part (measured by millimeters)
    Time Frame
    at baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis acute unilateral Bell's palsy. Exclusion Criteria: Any concurrent acute ischemia either cardiovascular or cerebrovascular disease. Diabetic patients
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aya Hassan Elmahdy
    Phone
    +201015722101
    Email
    d_ayaelmahdy@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shereen Refaat Kamel
    Phone
    +201065800025
    Email
    sh_rr70@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27734980
    Citation
    Monini S, Iacolucci CM, Di Traglia M, Lazzarino AI, Barbara M. Role of Kabat rehabilitation in facial nerve palsy: a randomised study on severe cases of Bell's palsy. Acta Otorhinolaryngol Ital. 2016 Aug;36(4):282-288. doi: 10.14639/0392-100X-783.
    Results Reference
    background

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    Kabat Rehabilitation Technique Versus Conventional Physical Therapy in Treatment of Bell's Palsy

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