Non-phonatory Exercises in Patients with Unilateral Vocal Fold Paralysis Post-thyroidectomy (ENFP)

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

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.

Study Overview

• Status: Completed
• Conditions: Unilateral Vocal Cord Paralysis
• Intervention / Treatment: Behavioral: Non-phonatory exercises

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli - IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Laryngeal Diseases; Vagus Nerve Diseases; Paralysis; Vocal Cord Paralysis
• Other Study ID Numbers: 5559

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No