NCT04807491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

December 21, 2020

Last Update Submit

March 18, 2021

Conditions

Keywords

Bell PalsyPNFKabat therapysynkinesis

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (1)

  • Facial Disability Index

    4 weeks

Other Outcomes (1)

  • Synkinesis Assessment Questionnair:

    4 weeks

Study Arms (2)

Kabat Technique's

ACTIVE COMPARATOR

Kabat exercises on Upper fulcrum, Intermediate fulcrum and lower fulcrum

Other: Kabat Technique's

Neuromuscular Re-Education:

EXPERIMENTAL

For initiation, Facilitation, Movement control and movement control

Other: Neuromuscular Re-Education

Interventions

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

Kabat Technique's

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

Neuromuscular Re-Education:

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed cases of bell's palsy
  • Non traumatic onset ( conditions like infectious, hypertensive patients, diabetic patients

You may not qualify if:

  • History of significant psychiatric illness
  • Upper motor neuron disease ( stroke, TBI, tumor)
  • Non co-operative patients
  • Post-surgical case

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (12)

  • 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.

    PMID: 27734980BACKGROUND
  • 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.

    PMID: 23549520BACKGROUND
  • 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.

    PMID: 25785922BACKGROUND
  • 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.

    PMID: 22161401BACKGROUND
  • 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.

    PMID: 19430987BACKGROUND
  • 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.

    PMID: 24505900BACKGROUND
  • 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.

    PMID: 28539869BACKGROUND
  • 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. doi: 10.1177/0269215507070790.

    PMID: 17613574BACKGROUND
  • Mehta RP, WernickRobinson M, Hadlock TA. Validation of the Synkinesis Assessment Questionnaire. Laryngoscope. 2007 May;117(5):923-6. doi: 10.1097/MLG.0b013e3180412460.

    PMID: 17473697BACKGROUND
  • 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.

    PMID: 20422701BACKGROUND
  • 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.

    PMID: 25357164BACKGROUND
  • 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.

    PMID: 26377698BACKGROUND

MeSH Terms

Conditions

Bell PalsySynkinesis

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Aruba Saeed, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2020

First Posted

March 19, 2021

Study Start

November 15, 2020

Primary Completion

December 15, 2020

Study Completion

December 30, 2020

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations