Eye Soft Surgery for Facial Sinkynesis

Not Applicable

Completed

• Conditions: Facial Paralysis; Sinkynesis
• Interventions: Other: Physical Rehabilitation; Procedure: Eye soft surgery

• Registration Number: NCT06538103
• Lead Sponsor: University of Catania

Brief Summary

Facial synkinesis (FS) is a distressing sequela of facial palsy (FP) characterized by involuntary, simultaneous movements of facial muscles occurring during voluntary facial expressions. Treatment of synkinesis is challenging, and preventive methods are needed.

This study evaluates the efficacy of physical facial nerve rehabilitation (PFNR) therapy alone versus PNFR with eyelid surgery to correct lagophthalmos and prevent the onset of synkinesis.

25 outpatients are randomized to receive either PFNR alone (neuromuscular retraining and Kabat proprioceptive neuromuscular facilitation) or PNFR and early (90 days after FP onset) eyelid surgery (involving a conservative oculoplastic correction for lagophthalmos with epiphora or ectropion). Comprehensive otolaryngological assessments and Magnetic Resonance Imaging (MRI) will be conducted. Synkinesis progression was measured using Another Disease Scale (ADS) at baseline, 3 months 6 months, 12 months, and 24-months post-treatment. The data were analyzed with ANOVA, t-test, Chi-Square analyses.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Primary Completion: 2023-03-15
• Study Completion: 2023-11-30
• Status Verified: 2024-07
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• people over 18 years old
• willingness to participate
• acute/new onset of FP (less than 15 days)

Exclusion Criteria

• neuro-inflammatory diseases (e.g., Multiple Sclerosis)
• FP from systemic disorders (e.g., Guillain-Barré syndrome, Lyme disease, encephalitis)
• FP from middle ear infections or untreated cholesteatoma
• severe cognitive or psychological disorders
• non-consent to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Physical Rehabilitation	Kabat therapy and neuromuscular reeducation (NMR) at home
Treatment	Eye soft surgery	Kabat therapy home NMR, and eyelid surgery at 90 days (if lagophthalmos with epiphora or ectropion was present)
Treatment	Physical Rehabilitation	Kabat therapy home NMR, and eyelid surgery at 90 days (if lagophthalmos with epiphora or ectropion was present)

Primary Outcome Measures

Name	Time	Method
Sinkinesis	3, 6, 12, 24 months	Presence or absence

Secondary Outcome Measures

Name	Time	Method
Time to recover facial motility	3, 6, 12, 24 months	Evaluation of months needed to recover
Recovery of Facial motility	3, 6, 12, 24 months	ADS will be used to evaluate the recovery of facial motility

Trial Locations

Locations (1)

Arianna Di Stadio; 🇮🇹 Catania, Sicily, Italy