- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04807491
Kabat Technique and Neuromuscular Effect in Patients With Bell's Palsy
Effects of Kabat Technique and Neuromuscular Re-Education in Patients With Bell's Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Islamabad, Pakistan, 44000
- Riphah International University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Kabat Technique's
Kabat exercises on Upper fulcrum, Intermediate fulcrum and lower fulcrum
|
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 |
Experimental: Neuromuscular Re-Education:
For initiation, Facilitation, Movement control and movement control
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SunnyBrook Facial Grading System
Time Frame: 4 weeks
|
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.
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4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Facial Disability Index
Time Frame: 4 weeks
|
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.
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4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Synkinesis Assessment Questionnair:
Time Frame: 4 weeks
|
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
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4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr Aruba Saeed, PHD*, Riphah International University
Publications and helpful links
General 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.
- 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.
- 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. Review.
- Teixeira LJ, Valbuza JS, Prado GF. Physical therapy for Bell's palsy (idiopathic facial paralysis). Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006283. doi: 10.1002/14651858.CD006283.pub3.
- Barbara M, Antonini G, Vestri A, Volpini L, Monini S. Role of Kabat physical rehabilitation in Bell's palsy: a randomized trial. Acta Otolaryngol. 2010;130(1):167-72. doi: 10.3109/00016480902882469.
- Sardaru D, Pendefunda L. Neuro-proprioceptive facilitation in the re-education of functional problems in facial paralysis. A practical approach. Rev Med Chir Soc Med Nat Iasi. 2013 Jan-Mar;117(1):101-6.
- Aranha VP, Samuel AJ, Narkeesh K. Correct the smile of a child by neuromuscular facilitation technique: An interesting case report. Int J Health Sci (Qassim). 2017 Apr-Jun;11(2):83-84.
- Manikandan N. Effect of facial neuromuscular re-education on facial symmetry in patients with Bell's palsy: a randomized controlled trial. Clin Rehabil. 2007 Apr;21(4):338-43.
- Mehta RP, WernickRobinson M, Hadlock TA. Validation of the Synkinesis Assessment Questionnaire. Laryngoscope. 2007 May;117(5):923-6. doi: 10.1097/MLG.0b013e3180412460.
- Neely JG, Cherian NG, Dickerson CB, Nedzelski JM. Sunnybrook facial grading system: reliability and criteria for grading. Laryngoscope. 2010 May;120(5):1038-45. doi: 10.1002/lary.20868.
- Fattah AY, Gurusinghe ADR, Gavilan J, Hadlock TA, Marcus JR, Marres H, Nduka CC, Slattery WH, Snyder-Warwick AK; Sir Charles Bell Society. Facial nerve grading instruments: systematic review of the literature and suggestion for uniformity. Plast Reconstr Surg. 2015 Feb;135(2):569-579. doi: 10.1097/PRS.0000000000000905. Review.
- Kleiss IJ, Beurskens CH, Stalmeier PF, Ingels KJ, Marres HA. Synkinesis assessment in facial palsy: validation of the Dutch Synkinesis Assessment Questionnaire. Acta Neurol Belg. 2016 Jun;116(2):171-8. doi: 10.1007/s13760-015-0528-7. Epub 2015 Sep 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00659 Muhammad Kashif
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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