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

Unilateral Vocal Cord Paralysis Clinical Trial

— ENFP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05963165
• Other study ID #: 5559
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: July 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Lucia D'Alatri, MD
• Phone: 0630155193
• Email: lucia.dalatri[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: January 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Unilateral Vocal Cord Paralysis
• Vocal Cord Paralysis

Intervention

Behavioral:
• Non-phonatory exercises
Muscle exercises that favor glottic adduction without vocal emissions

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli - IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	MPT	the Maximum Phonatory Time (MPT) will be evaluated on a sustained /a/ (minimum 3 seconds)	3 months