Clinical trial NCT06083389: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bell's Palsy
Keywords: rehabilitation facial palsy
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis acute unilateral Bell's palsy.

Exclusion Criteria:

1. Any concurrent acute ischemia either cardiovascular or cerebrovascular disease.
2. Diabetic patients

Primary outcomes:
measure: facial nerve ultrasonography
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.