Effect of Neural Mobilization in Bells Palsy: A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Bell Palsy

• Registration Number: NCT04280120
• Lead Sponsor: Majmaah University

Brief Summary

Bells palsy is a sudden paralysis of half of the facial muscle. The BP is idiopathic and 70% responds well with drug therapy. There are many complementary therapies such as , tapping, electrical stimulation, and massage that adds to the recovery of condition. However, efficacy of neural mobilization in BP is not reported in the scientific literature.

Detailed Description

Bells Palsy responds well with drug therapy such as prednisolone and antiviral drugs for the duration of 10-12 days. However, the administration of these drugs produce adverse side effect. Therapist use a number of techniques to maintain the physiological properties of facial muscles. However, adding a new technique would add to the arsenal of techniques available for the therapist. The research is intended to determine the effect of adding Neural mobilization in the recovery of Bells Palsy. A randomized controlled trail is intended to include 60 participants divided into two groups. Experimental group will receive Neural Mobilization with conservative treatment and control group will receive conservative treatment only.

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-21
• Study Start: 2020-03-01
• Primary Completion: 2021-05-15
• Study Completion: 2021-05-20
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• The first episode of Bell's palsy.
• Modified House-Brackmann scale III-IV.

Exclusion Criteria

• Diabetic
• Recurrent Bells palsy
• facial palsy
• History of stroke
• Any cerebrovascular accident
• epilepsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sunnybrook facial assessment scale	1 year	Sunnybrook facial assessment scale is a scale to assess quantitatively the facial asymmetry. It is a weighted scale based on evaluation of 3 different sub-scale including resting symmetry, the symmetry of voluntary movement, and severity of synkinesis to form one single composite score from 0 to 100. Firstly, the physiotherapist assesses the symmetry of the eye (0-1), cheek (0-2), and mouth (0-1) at rest. (0=normal, the weighted factor of 5). Secondly, the Physiotherapist rates facial movements during 5 standard facial expressions: a brow lift, gentile eye closure, open mouth smile, snarl and lip pucker, on a scale of 1 to 5 (1=no movement, to 5=normal movement). The values are added together and multiplied by 4. In the 3rd step, the severity of synkinesis on a 3-point scale (0=none, to 3=severe) during the 5 expressions as in the 2nd step. The overall score is given by the symmetry value of the voluntary movements minus the resting symmetry and the synkinesis.
Kinovea© tool for facial movement analysis	1 year	As a secondary outcome, we used Kinovea©, a free and open-source tool for movement analysis (Kinovea©, 0.8.15 2006 to 2011; Joan Charmant \& Contrib, Bordeaux, France). From plain video-recordings of movements, the software allows measuring distances and times, manually or using semi-automated tracking to follow points and check live values or trajectories. Facial distances were measured after maximal contractions movements of 3 selected facial muscles: frontalis, orbicularis oris, zygomatic. A symmetry ratio calculated comparing sides of each movement pattern. Subjects had to look straight ahead towards a specified target fixed on the facing wall and it was asked them not to move during video acquisitions. It was asked to keep the head lean the wall, keeping firm it during the 3 tested movements.

Trial Locations

Locations (2)

IAMR; 🇮🇳 Ghāziābād, UP, India

Faizan Kashoo; 🇮🇳 Meerut, UP, India