Clinical trial NCT06775717: Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and QoF in Bell's Palsy Patients.
Official title: Comparative Effects of Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and Quality of Life in Bell's Palsy Patients.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Bell Palsy
Keywords: Facial asymmetry
Quality of life
Facial function
Mirror therapy
Motor Imagery
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Facial Clinometric Scale:
timeFrame: 4 weeks
measure: Sunnybrook Facial Grading Scale:
timeFrame: 4 weeks
measure: Synkinesis Assessment Scale:
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Bashir Hospital.
state: Punjab
city: Sialkot
country: Pakistan
facility: Sulehri Children Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sabiha Arshad
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Singh A, Deshmukh P. Bell's Palsy: A Review. Cureus. 2022 Oct 11;14(10):e30186. doi: 10.7759/cureus.30186. eCollection 2022 Oct.