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临床试验/NCT06538103
NCT06538103已完成不适用

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

University of Catania2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年1月18日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arianna Di Stadio

Associate Professor (temporary)

University of Catania

研究点 (2)

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