Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and QoF in Bell's Palsy Patients.

January 10, 2025 updated by: Riphah International University

Comparative Effects of Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and Quality of Life in Bell's Palsy Patients.

Bell's palsy is a condition that causes sudden weakness in the muscles on one side of the face. The weakness makes half of the face appear to droop, difficulty in closing eyes and synkinesis. Mirror therapy and Motor imagery have shown promise in improving motor function and overall well-being.

Participant will be assigned two groups, A and B. All the groups will receive interventions for five days a week for 8 weeks and treatment time will be 35 minutes. The outcome measuring scales used will be facial Clinometric Scale (FaCE), Synkinesis Assessment Scale and Sunnybrook facial grading system to assess facial symmetry, synkinesis and facial movements, data will be collected on SPSS.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Bell's palsy is a condition that causes sudden weakness in the muscles on one side of the face. The weakness makes half of the face appear to droop, difficulty in closing eyes and synkinesis. These symptoms significantly impact facial symmetry and quality of life. Mirror therapy and Motor imagery have shown promise in improving motor function and overall well-being. The primary objective of this study is to compare the effects of the Mirror therapy and Motor Imagery on facial symmetry, synkinesis and quality of life in patients with Bell's palsy. This randomized clinical trial will be carried in 10 months after the approval of synopsis. Total number of 36 participants meeting the inclusion criteria will be included in this study through a non-probability convenience sampling technique. Participants will be randomly assigned into 2 groups using computer generated randomization method. Group A and Group participants will receive Motor Imagery and Mirror therapy, respectively. All the groups will receive interventions for five days a week for 8 weeks. Total treatment time will be 35 minutes. The outcome measuring scales used will be facial Clinometric Scale (FaCE), Synkinesis Assessment Scale and Sunnybrook facial grading system to assess facial symmetry, synkinesis and facial movements. The data will be analyze using SPSS version 28 for windows. Assessment will be carried out at baseline and four weeks, after discontinuation of treatment.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Sialkot, Punjab, Pakistan
        • Bashir Hospital.
      • Sialkot, Punjab, Pakistan
        • Sulehri Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years and above.
  • Both genders male and female will be included.
  • Patients diagnosed with Bell's palsy with relevant diagnostic criteria, including history. (tick bite, erythema migraine, pain), neurological examination including inspection of ear and infection of HIV, Herpes virus.
  • Patient having asymmetry in face (Sunnybrook Facial Grading Scale SFGS, use to check asymmetry in both sides of face).
  • Appearance of synkinesis on affected side (Synkinesis Assessment Scale)
  • Onset of symptoms must be first week.
  • Patient having sufficient, physical, and mental ability to understand instructions and cooperate throughout the session.

Exclusion Criteria:

  • Patients diagnosed with other than Bell's palsy (e.g., facial nerve trauma) (25).
  • Patients with severe co-morbidities (e.g., uncontrolled hypertension, diabetes, cardiovascular diseases).
  • Patients with significant cognitive impairment or communication difficulties who have undergone previous facial nerve surgery or interventions.
  • Patients with severe psychiatric conditions affecting compliance or participation and on psychiatric medications.
  • Patients with central nervous system tumor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motor Imagery with conventional Treatment.
21 patients will get the mirror therapy. Duration of sessions will be 35 minutes, with 5 sessions a week in 4 weeks.
Other: Motor Imagery with conventional Treatment
This treatment will be given 5 sessions a week in 4 consecutive weeks.
Other: Mirror therapy with conventional Treatment.
This treatment will be given 5 sessions a week in 4 consecutive weeks.
Active Comparator: Mirror therapy with conventional Treatment.
21 patients will get the mirror therapy. Duration of sessions will be 35 minutes, with 5 sessions a week in 4 consecutive weeks.
Other: Motor Imagery with conventional Treatment
This treatment will be given 5 sessions a week in 4 consecutive weeks.
Other: Mirror therapy with conventional Treatment.
This treatment will be given 5 sessions a week in 4 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Facial Clinometric Scale:
Time Frame: 4 weeks
The FaCE scale is a fascial palsy-related self-assessment QoL questionnaire comprising 15 questions based on a 5-point Likert-scale that evaluates the intensity and frequency of physical and psychosocial impairments in 6 domains of facial function: facial movement, facial comfort, eye comfort, oral function, lacrimal control and social function.
4 weeks
Sunnybrook Facial Grading Scale:
Time Frame: 4 weeks
Sunnybrook scale is considered the current standard in evaluating outcomes and synkinesis due to its comprehensive scope, ease of use, and rapid results interpretation (27). The Sunnybrook facial grading scale, unlike others, systematically focuses on each subunit of facial movement (eyebrows, eyelids, nasal base, upper lip, and lower lip), while subjects are instructed to make six simple facial expressions.
4 weeks
Synkinesis Assessment Scale:
Time Frame: 4 weeks
The phenomenon known as synkinesis occurs when there is intentional movement in one or more ipsilateral facial regions but involuntary movement in another area of the face.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sabiha Arshad, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC\RCR & AHS\24\0252

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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