Facial Paralysis, Sinkynesis
Conditions
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.
Interventions
PROCEDUREEye soft surgery
Early lower eyelid surgery will be performed in accordance with the protocol previously described by Di Stadio, with medial or lateral eyelid lifting surgery as indicated. The indication for eye surgery are in case of ectropion (exposure of the conjunctiva due to a reduction in tension of the anterior compartment of the eye muscle) and lagophthalmos (incomplete /abnormal closure of the eye with eyelid in closed position) a lateral lower eyelid lifting surgery is performed. otherwise, in presence of epiphora (the eversion of the lachrymal point) and lagophthalmos medial lower eyelid lifting surgery is done.
Kabat therapy and neuromuscular reeducation (NMR) at home Kabat therapy involved thrice-weekly 35-minute sessions.
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sinkinesis | 3, 6, 12, 24 months | Presence or absence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of Facial motility | 3, 6, 12, 24 months | ADS will be used to evaluate the recovery of facial motility |
| Time to recover facial motility | 3, 6, 12, 24 months | Evaluation of months needed to recover |
Countries
Italy
Outcome results
None listed