Eye Soft Surgery for Facial Sinkynesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2023-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Facial Paralysis Sinkynesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment

Kabat therapy home NMR, and eyelid surgery at 90 days (if lagophthalmos with epiphora or ectropion was present)

Group Type EXPERIMENTAL

Eye soft surgery

Intervention Type PROCEDURE

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 Rehabilitation

Intervention Type OTHER

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

Control

Kabat therapy and neuromuscular reeducation (NMR) at home

Group Type ACTIVE_COMPARATOR

Physical Rehabilitation

Intervention Type OTHER

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

Interventions

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Eye 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.

Intervention Type PROCEDURE

Physical Rehabilitation

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

Intervention Type OTHER

Other Intervention Names

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Lower eyelid surgery Kabat

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No