CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Eye soft surgery +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06538103
NCT06538103N/ACompleted

Combining Early Lower Eyelid Surgery With Neuromuscular Retraining for Synkinesis Prevention After Facial Palsy.

University of Catania·interventional·Posted Aug 5, 2024·Updated Aug 5, 2024

In Brief

A clinical study evaluating Eye soft surgery and Physical Rehabilitation for Facial Paralysis and Sinkynesis. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 5, 2024
Enrollment StartJan 18, 2022
Primary CompletionMar 15, 2023
Study CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 1.9 years ago

Interventions

Eye soft surgeryprocedure

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.

Physical Rehabilitationother

Kabat therapy and neuromuscular reeducation (NMR) at home Kabat therapy involved thrice-weekly 35-minute sessions.