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Enrolling by Invitation

NCT Number: NCT06775717

Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and QoF 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bashir Hospital., Sialkot, Punjab Province, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motor Imagery with conventional Treatment

Other

This treatment will be given 5 sessions a week in 4 consecutive weeks.

Mirror therapy with conventional Treatment.

Other

This treatment will be given 5 sessions a week in 4 consecutive weeks.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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