Combining Early Lower Eyelid Surgery With Neuromuscular Retraining for Synkinesis Prevention After Facial Palsy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Sinkinesis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •people over 18 years old
- •willingness to participate
- •acute/new onset of FP (less than 15 days)
排除标准
- •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
结局指标
主要结局
Sinkinesis
时间窗: 3, 6, 12, 24 months
Presence or absence
次要结局
- Time to recover facial motility(3, 6, 12, 24 months)
- Recovery of Facial motility(3, 6, 12, 24 months)
研究者
Arianna Di Stadio
Associate Professor (temporary)
University of Catania
