Bell's PalsyNCT06083389
Kabat Rehabilitation Technique Versus Conventional Physical Therapy in Treatment of Bell's Palsy
A study testing kabat technique for rehabilitation of facial palsy and electrotherapy in people with Bell's Palsy, run by Minia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- kabat technique for rehabilitation of facial palsy and electrotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis acute unilateral Bell's palsy.
Who cannot join
- Any concurrent acute ischemia either cardiovascular or cerebrovascular disease.
- Diabetic patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Kabat Rehabilitation Technique Versus Conventional Physical Therapy Along With Electrical Stimulation in Treatment of Bell's Palsy
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.
Read the 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
- Conditions
- Bell's Palsy
- Being tested
- kabat technique for rehabilitation of facial palsy, electrotherapy
- Keywords
- rehabilitation facial palsy
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kabat technique for rehabilitation of facial palsyBehavioural
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.
electrotherapyDevice
electrical stimulation of facial nerve supplied muscles.3 sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| traditional technique of facial exercises along with electrical stimulation of facial muscles. | Active comparator | 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. Receives: Device: electrotherapy |
| Kabat technique arm along with stimulation of facial muscles. | Active comparator | 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. Receives: Behavioral: kabat technique for rehabilitation of facial palsy; Device: electrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
facial nerve ultrasonography
Thickness of facial nerve measured at the thickest part (measured by millimeters)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study startDec 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bell's PalsyStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Hassan AbdelAzeem Ahmed, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083389
- Sponsor's protocol ID
- rehabilitation of facial balsy
- Status last verified
- Oct 2023
- First submitted
- 23 Mar 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27734980
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Kabat Rehabilitation Technique Versus Conventional Physical Therapy Along With Electrical Stimulation in Treatment of Bell's Palsy
- ClinicalTrials.gov ID
- NCT06083389
- Acronym / sponsor ID
- rehabilitation of facial balsy
- Conditions
- Bell's Palsy
- Keywords
- rehabilitation facial palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional technique of facial exercises along with electrical stimulation of facial muscles. | Active comparator | Device: electrotherapyfacial 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. |
| Kabat technique arm along with stimulation of facial muscles. | Active comparator | Behavioral: kabat technique for rehabilitation of facial palsy, Device: electrotherapyDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis acute unilateral Bell's palsy.
Key exclusion criteria (2 listed)
- Any concurrent acute ischemia either cardiovascular or cerebrovascular disease.
- Diabetic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kabat technique for rehabilitation of facial palsyTo 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. | Behavioural | Kabat technique arm along with stimulation of facial muscles. |
| electrotherapyelectrical stimulation of facial nerve supplied muscles.3 sessions per week. | Device | Kabat technique arm along with stimulation of facial muscles., traditional technique of facial exercises along with electrical stimulation of facial muscles. |
Primary outcome
facial nerve ultrasonography
Time frame: at baseline
Thickness of facial nerve measured at the thickest part (measured by millimeters)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Background: PubMed 27734980Monini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing kabat technique for rehabilitation of facial palsy and electrotherapy in people with Bell's Palsy, run by Minia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Hassan Elmahdy (+201015722101, d_ayaelmahdy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
facial nerve ultrasonography (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06083389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.