Early Speech Therapy Using Non-phonatory Exercises in Patients with Unilateral Vocal Fols Paralysis After Thyroidectomy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Degree of glottic closure
研究概览
简要总结
Thyroidectomy is the most common iatrogenic cause of vocal fold paralysis. Patients complain of hoarseness caused by incomplete glottic closure and have effort to raise vocal intensity with consequent elevation of the larynx and/or involvement of supraglottic structures in phonation. These compensation mechanisms result in a shift of the fundamental frequency towards more serious tones or falsetto voice emissions.
The first choice treatment is speech therapy which aims to obtain better glottic closure, preventing ankylosis of the crico-arytenoid joint. In order to promote better glottic closure without risking the onset or increase of dysfunctional compensation, the idea behind this project is to propose non-phonatory adduction exercises in the first post-operative week.
The primary objective of the study is to compare patients who will perform non-phonatory exercises in parallel with medical therapy for one week and patients who will perform standard medical therapy only during the first week.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •vocal fold paralysis after thyrodectomy
- •ability to sign an informed consent
排除标准
- •Vocal fold paralysis with different etiology
- •Previous history of laryngeal, pulmonary or gastric surgery
- •History of vocal or laryngeal pathologies that have required therapy
- •Current or previous lung disorders
- •Hearing loss
- •Motor or neurological deficits
- •Presence of malignant diseases
- •Presence of speech or reading disorders
结局指标
主要结局
Degree of glottic closure
时间窗: 3 months
A videostrobolaryngoscopy will be performed. The recorded videos will be viewed by expert clinicians and a numerical score will be assigned relating to the degree of glottic adduction on a 7-point scale.
次要结局
- Acoustic analysis (fundamental frequency)(3 months)
- Acoustic analysis (NHR)(3 months)
- Acoustic analysis (Shimmer%)(3 months)
- Acoustic analysis (Jitter%)(3 months)
- Acoustic analysis (intensity)(3 months)
- Acoustic analysis (Flow)(3 months)
- Acoustic analysis (Fhigh)(3 months)
- MPT(3 months)
研究者
D'Alatri Lucia
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
