Improvement of Facial Symmetry With Myofunctional Therapy Combined to Botulinum Toxin Injections in Long Standing Facial Paralysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Clinical score
研究概览
简要总结
Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin injection in patients with long standing facial unilateral palsy.
详细描述
Twenty-five patients with long standing facial palsy were studied; all had been previously treated for facial reanimation. Patients were randomly divided in two groups; Group A did the myofunctional therapy sessions with the speech therapist before the botulinum toxin injection, while the participants of Group B did the myofunctional therapy after it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 62 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •facial paralysis with more than 2 years elapsed since the onset of symptoms
- •surgically treated for reanimation at least 12 months before
- •static and/or dynamic facial asymmetry causing aesthetic concern
排除标准
- •spastic paralysis
- •serious systemic or neuromuscular diseases
- •cognition impairment
- •pregnant women
研究组 & 干预措施
A: myofunctional prior to botulinum
All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group A, botulinum toxin was applied after myofunctional therapy.
干预措施: Botulinum Toxin Type A (Drug)
A: myofunctional prior to botulinum
All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group A, botulinum toxin was applied after myofunctional therapy.
干预措施: myofunctional therapy (Procedure)
B: myofunctional after botulinum
All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group B, botulinum toxin was applied before myofunctional therapy.
干预措施: Botulinum Toxin Type A (Drug)
B: myofunctional after botulinum
All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group B, botulinum toxin was applied before myofunctional therapy.
干预措施: myofunctional therapy (Procedure)
结局指标
主要结局
Clinical score
时间窗: 2 months
次要结局
- Facial Disability Index (self-report instrument)(2 months)