Non-phonatory Exercises in Patients With Unilateral Vocal Fold Paralysis Post-thyroidectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Unilateral Vocal Cord Paralysis

Intervention / Treatment
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* Behavioral: Non-phonatory exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Patients who will perform non-phonatory exercises in parallel with medical therapy for the first week | Behavioral: Non-phonatory exercises<br>* Muscle exercises that favor glottic adduction without vocal emissions<br>|
| No Intervention: Control group<br>patients who will perform standard medical therapy only during the first week. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of glottic closure | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acoustic analysis (fundamental frequency) | Through the use of the Praat software, on the reading of the piece The desert and on a sustained /a/ the Fundamental Frequency (F0, Hz) will be analysed. | 3 months | 
| Acoustic analysis (NHR) | Through the use of the Praat software, on the reading of the piece The desert and on a sustained /a/ the noise/harmonics ratio (NHR) will be analysed. | 3 months | 
| Acoustic analysis (Jitter%) | Through the use of the Praat software, on the reading of the piece The desert and on a sustained /a/ the Jitter (%) will be analysed. | 3 months | 
| Acoustic analysis (Shimmer%) | Through the use of the Praat software, on the reading of the piece The desert and on a sustained /a/ the Shimmer ( %) will be analysed. f | 3 months | 
| Acoustic analysis (Flow) | Through the use of the Praat software, on the reading of the piece The desert and on a sustained /a/ the minimum frequency (Flow) will be analysed. | 3 months | 
| Acoustic analysis (Fhigh) | Through the use of the Praat software, on the reading of the piece The desert and on a sustained /a/ the maximum frequency (Fhigh) will be analysed. | 3 months | 
| Acoustic analysis (intensity) | Through the use of the Praat software, on the reading of the piece The desert and on a sustained /a/ the intensity (dB) will be analysed. | 3 months | 
| MPT | the Maximum Phonatory Time (MPT) will be evaluated on a sustained /a/ (minimum 3 seconds) | 3 months |