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

NCT06775717 | Enrolling By Invitation

• 1 other identifier: REC\RCR & AHS\24\0252
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Bell Palsy

Keywords

Facial asymmetry; Quality of life; Facial function; Mirror therapy; Motor Imagery

Outcome Measures

Primary Outcomes (3)

• The Facial Clinometric Scale:

  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:

  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:

  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

Study Arms (2)

Motor Imagery with conventional Treatment.

EXPERIMENTAL

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; Other: Mirror therapy with conventional Treatment.

Mirror therapy with conventional Treatment.

ACTIVE COMPARATOR

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; Other: Mirror therapy with conventional Treatment.

Interventions

Motor Imagery with conventional Treatment OTHER

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

Mirror therapy with conventional Treatment.; Motor Imagery with conventional Treatment.

Mirror therapy with conventional Treatment. OTHER

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

Mirror therapy with conventional Treatment.; Motor Imagery with conventional Treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Bashir Hospital.

Sialkot, Punjab Province, Pakistan

Location

Sulehri Children Hospital

Sialkot, Punjab Province, Pakistan

Location

Related Publications (6)

• Castaldo M, Sellitto G, Ruotolo I, Berardi A, Galeoto G. The Use of Mirror Therapy in Peripheral Seventh Nerve Palsy: A Systematic Review. Brain Sci. 2024 May 23;14(6):530. doi: 10.3390/brainsci14060530.

  PMID: 38928530 BACKGROUND

• Patel H, Landge P, Barot J. A Comparative Study to Analyse the Effect of Motor Imagery and Mirror Book Therapy Versus Mime Therapy for the Recovery in Patients with Acute Bell's Palsy. Int J Sci Res. 2023;12(12):2047-55.

  BACKGROUND

• Roh TS, Jung BK, Yun I, Lew DH, Kim YS. Effect of botulinum toxin A on vasoconstriction and sympathetic neurotransmitters in a murine random pattern skin flap model. Wound Repair Regen. 2017 Jan;25(1):75-85. doi: 10.1111/wrr.12501. Epub 2017 Jan 5.

  PMID: 27997734 BACKGROUND

• Khanzada K, Ijaz Gondal M, Qamar M, Basharat A, Ahmad W, Ali S. Comparison of efficacy of Kabat rehabilitation and facial exercises along with nerve stimulation in patients with Bell's palsy. BLDE Univ J Heal Sci. 2018;3(1):31.

  BACKGROUND

• Baugh RF, Basura GJ, Ishii LE, Schwartz SR, Drumheller CM, Burkholder R, Deckard NA, Dawson C, Driscoll C, Gillespie MB, Gurgel RK, Halperin J, Khalid AN, Kumar KA, Micco A, Munsell D, Rosenbaum S, Vaughan W. Clinical practice guideline: Bell's palsy. Otolaryngol Head Neck Surg. 2013 Nov;149(3 Suppl):S1-27. doi: 10.1177/0194599813505967.

  PMID: 24189771 BACKGROUND

• Singh A, Deshmukh P. Bell's Palsy: A Review. Cureus. 2022 Oct 11;14(10):e30186. doi: 10.7759/cureus.30186. eCollection 2022 Oct.

  PMID: 36397921 BACKGROUND

MeSH Terms

Conditions

Bell Palsy; Facial Asymmetry

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Sabiha Arshad

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: October 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)