Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy

Bell Palsy Clinical Trial

Official title:

Comparative Effects of Mime Therapy and Action Observation Therapy on Facial Symmetry and Quality of Life in Bell's Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308250
• Other study ID #: REC/RCR&AHS/23/0294
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2024
• Est. completion date: May 15, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: Muhammad Kashif, PhD-PT
• Phone: 03333125303
• Email: kashif.shaffi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine comparative effects of mime therapy and action observation therapy on facial symmetry and quality of life in Bell's palsy. Bell's palsy is characterized as an abrupt paralysis of the peripheral facial nerve, typically without a known cause. Mime Therapy is a performing technique that helps patients regain the ability to use their face muscles. Action observation therapy is novel rehabilitation approach exploiting this mirror mechanism.

Description:

This randomized clinical trial will be conducted at Sir Ganga Ram Hospital in 7 months. 62 participants with Bell's palsy will be included as per sample size calculation through convenience sampling technique. Participants which meet inclusion criteria will be randomly allocated using online randomization tool into two groups. Group A will receive Mime therapy for 30 minutes with short resting interval and Group B will receive action observation therapy for 30 minutes. Each group will receive treatment session of 5 days per week for 6 weeks.

Facial symmetry will be measured using the 13-item Sunny Brook facial Grading System, Facial disability index will be used to assess the quality of life and The House-Brackmann Facial Nerve Grading System will be used to characterize the degree of facial paralysis. The data will be analyzed using SPSS version 24 for Windows software.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: May 15, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Bell's Palsy with acute onset of 1-3 weeks.

2. Unilateral loss of facial weakness.

3. Patients with intact taste sensation.

4. Bell's Palsy of House Brackmann grade 3 and 4.

5. Idiopathic Bell's Palsy.

Exclusion Criteria:

1. History of facial palsy recurrence.

2. Stroke associated Bells palsy.

3. History of pregnancy

4. Subjects with any disability, fracture, or tumor.

5. History of facial surgery.

6. Subject having skin allergy on face.

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Paralysis

Intervention

Other:
• MIME THERAPY
Mime therapy consist of: Self massage: patients will be taught to massage their face and neck daily for about 10 minutes which includes effleurage and kneading of both sides of face. Breathing exercises: patient will be taught to recognize tension and feel the difference between tension and relaxation in facial musculature for 5 minutes. Expiration exercises will be used to induce relaxation. Articulation: vowels such as a,e,i,o,u and consonants such as p and b will be used to teach position of the lips for 5 minutes. Facial expression exercises: forehead wrinkle, smiling, eye closure, frowning, disgust, surprise, anger, sadness will be performed for 10 minutes
• ACTION OBSERVATION THERAPY
Function of each of the muscle is observed for 3 minutes and then executed for 2 minutes. Frontalis (Raising eyebrows and forehead wrinkling). Corrugator Supercili (Moving the eyebrow down and inward toward the nose and inner eye). Orbicularis oculi (Closing the eyelids). Buccinator (Blowing air in and out of the mouth). Zygomaticus major (Smiling). Orbicularis oris (Lip pursing or puckering).

Locations

Country	Name	City	State
Pakistan	Riphah International University	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sunny Brook Facial Grading System	The system includes three components: resting symmetry, the symmetry of voluntary movements, and synkinesis. A composite facial symmetry score is calculated as [4 × symmetry of voluntary movement - 5 × resting asymmetry + 1 × synkinesis] with 100 representing normal facial symmetry.	6th week
Primary	Facial Disability Index	it is used to assess the quality of life in patients with bell's palsy. It also helps to measure the difficulties of the face in activities of daily living. It represents the relationship between impairments, disability, and psychosocial status and also focuses on the disability of individuals with disorders of the facial motor system. The individual subscales are scored out of a total of 100 where the highest score is the best result.	6th week