Early Speech Therapy Using Non-phonatory Exercises in Patients with Unilateral Vocal Fols Paralysis After Thyroidectomy: a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Unilateral Vocal Cord Paralysis
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Degree of glottic closure
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
D'Alatri Lucia
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility Criteria
Inclusion Criteria
- •vocal fold paralysis after thyrodectomy
- •ability to sign an informed consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Degree of glottic closure
Time Frame: 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.
Secondary Outcomes
- 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)