NCT06308250

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

March 4, 2024

Last Update Submit

July 16, 2024

Conditions

Keywords

Bell PalsyBreathing exerciseComparativeMIME ProtocolRandomized clinical trial

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

GROUP A ( MIME THERAPY)

EXPERIMENTAL

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: 1. Self massage of 10 minutes, 2. Breathing and relaxation exercises of 5 minutes, 3. Articulation of 5 minutes and 4. Facial expression exercises of 10 minutes.

Other: MIME THERAPY

GROUP B (ACTION OBSERVATION THERAPY)

EXPERIMENTAL

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

Interventions

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

GROUP A ( MIME 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).

GROUP B (ACTION OBSERVATION THERAPY)

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Bell's Palsy with acute onset of 1-3 weeks.
  • Unilateral loss of facial weakness.
  • Patients with intact taste sensation.
  • Bell's Palsy of House Brackmann grade 3 and 4.
  • Idiopathic Bell's Palsy.

You may not qualify if:

  • History of facial palsy recurrence.
  • Stroke associated Bells palsy.
  • History of pregnancy
  • Subjects with any disability, fracture, or tumor.
  • History of facial surgery.
  • Subject having skin allergy on face.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

Location

MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Muhmmad Kashif, PhD-PT

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 13, 2024

Study Start

February 25, 2024

Primary Completion

July 10, 2024

Study Completion

July 10, 2024

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations