Kabat Technique and Neuromuscular Effect in Patients With Bell's Palsy
Primary Purpose
Bell Palsy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Kabat Technique's
Neuromuscular Re-Education
Sponsored by
About this trial
This is an interventional treatment trial for Bell Palsy focused on measuring Bell Palsy, PNF, Kabat therapy, synkinesis
Eligibility Criteria
Inclusion Criteria:
- Diagnosed cases of bell's palsy
- Non traumatic onset ( conditions like infectious, hypertensive patients, diabetic patients
Exclusion Criteria:
• History of significant psychiatric illness
- Upper motor neuron disease ( stroke, TBI, tumor)
- Non co-operative patients
- Post-surgical case
Sites / Locations
- Riphah International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Kabat Technique's
Neuromuscular Re-Education:
Arm Description
Kabat exercises on Upper fulcrum, Intermediate fulcrum and lower fulcrum
For initiation, Facilitation, Movement control and movement control
Outcomes
Primary Outcome Measures
SunnyBrook Facial Grading System
the tool is used to assess changes from baseline to 4 weeks The Sunnybrook scale is a regional weighted scale based on evaluation of different regions including resting symmetry, symmetry of voluntary movement and severity of Synkinesis to form one single composite score from 0 to 100. It was devised and established at the Sunnybrook Health Sciences Centre in Toronto having an intraclass correlation coefficient (ICC) of 0.890. The Facial Grading System is a tool used for clinical evaluation of Facial Nerve function. It is intended to use on peoples with facial nerve weaknes.
Secondary Outcome Measures
Facial Disability Index
the tool is used to assess changes from baseline to 4 weeks The Facial Disability Index (FDI) is a condition-specific scale that is proposed to be used to help clinicians in making decisions about individual patients and to differentiate among individuals with different levels of disability and to evaluate change within a person over time. It have 2 domains, i.e. physical function and social wellbeing. It have total 10 questions, 5/domain. Each item is rated on a 6-point scale, ranging from severe disability to absence of disability. Both subscales are transformed to a score on a 100-point scale, with 100 indicating unimpaired physical or social/well-being function.
Full Information
NCT ID
NCT04807491
First Posted
December 21, 2020
Last Updated
March 18, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04807491
Brief Title
Kabat Technique and Neuromuscular Effect in Patients With Bell's Palsy
Official Title
Effects of Kabat Technique and Neuromuscular Re-Education in Patients With Bell's Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bell's palsy is the sudden one-sided peripheral weakness of seventh cranial nerve (Facial nerve), represents 50% to 75% of all etiologies with a rate of 58.2 to 8 new cases per 1 million per year. The objective is to compare the effects of Kabat techniques and Neuromuscular Re-Education on facial disability and synkinesis in patients with bell's palsy. A Randomized Control Trial was conducted on 20 participants, equally allocated in Kabat and PNF training group from February-2020 until December- 2020. Participants were selected according to inclusion and exclusion criteria on purposive sampling technique and randomization was done by sealed envelope method. The assessment was done after taking consent before the first and last session. The tools included Facial disability index, Sunnybrook facial grading system and synkinesis assessment questionnaire. Data were analyzed using SPSS v.20.
Detailed Description
Bell's palsy is the sudden one-sided peripheral weakness of seventh cranial nerve (Facial nerve), represents 50% to 75% of all etiologies with the rate of 58.2 to 8 new cases per 1 million per year. It can be either a complete palsy or weakness of facial nerve. This condition may start with pain over half of face especially mastoid region with other symptoms like decreased sensation over half of face, decrease lacrimation, hyperacusis, pain and numbness over half of face. Bell's palsy patients may show signs of absent/decrease facial creases, positive bells phenomenon and forehead folds, associated with other disabilities like contracture in facial muscles and synkinesis due to which patient cannot close his eye.The cause of bell's palsy is unknown therefore it is also called idiopathic facial palsy but recent studies claim that "herpes simplex virus" can be a cause of bell's palsy.Other causes such as tooth extraction, removal of the tumour, local anaesthesia, TMJ surgery, ischemic neuropathy, facial fracture can also be considered. Different studies were carried out on the incidence, risk factors and treatments methods of bell's palsy.The most common risk factors for bell's palsy, reported by a study, is diabetes, and hypertension. A study reported that patients with diabetes are 4 to 5 times more likely to have Bell's palsy.Men and women are equally affected by this disorder.There are different treatment methods for Bells palsy i.e. medical management, physical therapy management, surgical management etc.Although Physical therapy management is not considered to be treatment of choice in treating bell's palsy but there is several clinical studies which claims the benefits of rehabilitation if applied in early stage. Physical therapy managements include different techniques, namely Proprioceptive neuromuscular facilitation, Kabat rehabilitation, Kinisio taping, cryotherapy, massage therapy biofeedback, muscular reeducation.As claimed in a study in 2013, Kabat technique is quite effective in treating the facial disabilities if the therapist is trained. In this study different Kabat techniques namely "rhythmic initiation on those patients who did not perform any movement, repeated stretch was used at the start and also through full ROM in case of muscular weakness, isotonic were used when patients had voluntary movement control, were used on three patients .A study claimed in a case report in 2017 that PNF techniques are very effective in improving functional outcomes in Childs with "bell's palsy".Several studies were done on effects of "Kabat rehabilitation" in "Bell's Palsy". As another conducted a study in 2017.Two groups of Bell's palsy were compared after application of two different treatment protocols. Participants of group A was given Kabat exercises with electrical stimulation and kinesio taping while group B was given electrical stimulation plus home exercises. Study reported that Kabat exercise is quite effective in improving facial asymmetry in bell's palsy.A study was done in 2015 in Islamabad compare the effects of Kabat exercises and Taping in reducing facial synkinesis and disability.The study reported that Kabat exercises are more effective in reducing facial synkinesis and disability.A study was done in 2007, Comparing Neuromuscular reeducation techniques with conventional physical therapy in treating Bell's palsy. This study was done in manipal, India in which he reported that neuromuscular reeducation techniques are more effective in improving facial asymmetry in patients with bell's palsy .The previous studies showed that clinician have worked either with Neuromuscular Re-Education or with kabat in treating Bell's palsy. There is no study done which compare the effects of Neuromuscular Re-Education vs. Kabat in treating Bell's palsy. So the aim of this study is to determine the effect of Kabat and Neuromuscular Re-Education on facial disability and synkinesis and to compare both treatments effects.Kabat Exercises rehabilitation of the facial nerve, 3 fulcrums are found, whose muscles can be stimulated. Upper fulcrum: includes the frontalis, corrugator and orbicularis muscles of the eye.Intermediate fulcrum: Includes the common elevator muscle of the upper lip and wing of nose, the dilator naris and the multiform. Lower fulcrum includes the zygomaticus major, the zygomaticus minor, the risorius, the orbicularis, the triangular of the lower lip, buccinator, chin muscle and square muscle of the chin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
Keywords
Bell Palsy, PNF, Kabat therapy, synkinesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kabat Technique's
Arm Type
Active Comparator
Arm Description
Kabat exercises on Upper fulcrum, Intermediate fulcrum and lower fulcrum
Arm Title
Neuromuscular Re-Education:
Arm Type
Experimental
Arm Description
For initiation, Facilitation, Movement control and movement control
Intervention Type
Other
Intervention Name(s)
Kabat Technique's
Intervention Description
As with all cranial nerves, some specific techniques can also be applied on the facial nerve to enhance responses and improve recovery; the most important are: The rhythmic start: shows and guides the subject into the movements and the scheme; agonist investigation utilizes sequential concentric and eccentric contractions; The inversion of the antagonist: reinforces responses through the induction phenomenon; Repeated contractions: calls for a response with repeated stretching that briefly enables movement; Isometric contractions: for stabilizing and reinforcing the response.
Conventional therapy exercises
Intervention Type
Other
Intervention Name(s)
Neuromuscular Re-Education
Intervention Description
After the baseline assessment, the participant in the control will receive Neuromuscular Re-Education. The duration of session will be 45 minutes.Neuromuscular Re-Education: For initiation (acute phase): Active-assisted exercise,Massage and stretch for affected side.For Facilitation ,Active-assisted exercise.For Movement control:Massage and stretching for facial retraction,Assisted and active exercises on involved side.
For Relaxation,Thermotherapy,Relaxation exercises,Alternating rhythmic movements.
Conventional therapy exercises
Primary Outcome Measure Information:
Title
SunnyBrook Facial Grading System
Description
the tool is used to assess changes from baseline to 4 weeks The Sunnybrook scale is a regional weighted scale based on evaluation of different regions including resting symmetry, symmetry of voluntary movement and severity of Synkinesis to form one single composite score from 0 to 100. It was devised and established at the Sunnybrook Health Sciences Centre in Toronto having an intraclass correlation coefficient (ICC) of 0.890. The Facial Grading System is a tool used for clinical evaluation of Facial Nerve function. It is intended to use on peoples with facial nerve weaknes.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Facial Disability Index
Description
the tool is used to assess changes from baseline to 4 weeks The Facial Disability Index (FDI) is a condition-specific scale that is proposed to be used to help clinicians in making decisions about individual patients and to differentiate among individuals with different levels of disability and to evaluate change within a person over time. It have 2 domains, i.e. physical function and social wellbeing. It have total 10 questions, 5/domain. Each item is rated on a 6-point scale, ranging from severe disability to absence of disability. Both subscales are transformed to a score on a 100-point scale, with 100 indicating unimpaired physical or social/well-being function.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Synkinesis Assessment Questionnair:
Description
the tool is used to assess changes from baseline to 4 weeks The Synkinesis Assessment Questionnaire (SAQ) is a valid, reliable, and easily administered instrument for the self-assessment of synkinesis in patients with facial palsy. This instrument was developed and validated in the Facial Nerve Center at the Massachusetts Eye and Ear Infirmary (Boston, USA) in 2007. The questionnaire consists of nine items. Total scores range from 0 (no synkinesis) to 100 (severe synkinesis, all the time). The SAQ is a reliable and valid tool having the Cronbach alpha for the final SAQ was 0.859
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosed cases of bell's palsy
Non traumatic onset ( conditions like infectious, hypertensive patients, diabetic patients
Exclusion Criteria:
• History of significant psychiatric illness
Upper motor neuron disease ( stroke, TBI, tumor)
Non co-operative patients
Post-surgical case
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Aruba Saeed, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27734980
Citation
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Results Reference
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Citation
Nicastri M, Mancini P, De Seta D, Bertoli G, Prosperini L, Toni D, Inghilleri M, Filipo R. Efficacy of early physical therapy in severe Bell's palsy: a randomized controlled trial. Neurorehabil Neural Repair. 2013 Jul-Aug;27(6):542-51. doi: 10.1177/1545968313481280. Epub 2013 Apr 2.
Results Reference
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25785922
Citation
Ferreira M, Marques EE, Duarte JA, Santos PC. Physical therapy with drug treatment in Bell palsy: a focused review. Am J Phys Med Rehabil. 2015 Apr;94(4):331-40. doi: 10.1097/PHM.0000000000000255.
Results Reference
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PubMed Identifier
22161401
Citation
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Results Reference
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Citation
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Citation
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Citation
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Citation
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Kabat Technique and Neuromuscular Effect in Patients With Bell's Palsy
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