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

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

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.

Study Overview

• Status: Completed
• Conditions: Bell Palsy
• Intervention / Treatment: Other: MIME THERAPY; Other: ACTION OBSERVATION THERAPY

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54660
      • Riphah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GROUP A ( MIME THERAPY); Group A will receive mime therapy of 30 minutes with short resting intervals. Treatment will be given 5 times per week for 6 weeks. Mime therapy consist of: Self massage of 10 minutes,; Breathing and relaxation exercises of 5 minutes,; Articulation of 5 minutes and; Facial expression exercises of 10 minutes.	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
Experimental: GROUP B (ACTION OBSERVATION THERAPY); Group B will receive action observation therapy of 30 minutes with short resting interval. The treatment will be given 5 times per week for 6 weeks. During the presentation of a video clip, patients sit relaxed in front of the computer screen while observing it. After observing a motor act for 3 min (observation phase) patients are required to imitate what they observed for 2 min (execution phase).	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Study Chair: Muhmmad Kashif, PhD-PT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2024
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Breathing exercise; Bell Palsy; Comparative; MIME Protocol
• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis
• Other Study ID Numbers: REC/RCR&AHS/23/0294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No