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临床试验/NCT05963165
NCT05963165已完成不适用

Early Speech Therapy Using Non-phonatory Exercises in Patients with Unilateral Vocal Fols Paralysis After Thyroidectomy: a Randomized Clinical Trial

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年7月1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
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

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

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

D'Alatri Lucia

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (2)

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