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

NCT05963165 | Completed DMC

• 1 other identifier: 5559
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Vocal Cord Paralysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Acoustic analysis (fundamental frequency)

  3 months

• Acoustic analysis (NHR)

  3 months

• Acoustic analysis (Jitter%)

  3 months

• Acoustic analysis (Shimmer%)

  3 months

• Acoustic analysis (Flow)

  3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients who will perform non-phonatory exercises in parallel with medical therapy for the first week

Behavioral: Non-phonatory exercises

Control group

NO INTERVENTION

patients who will perform standard medical therapy only during the first week.

Interventions

Non-phonatory exercises BEHAVIORAL

Muscle exercises that favor glottic adduction without vocal emissions

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• vocal fold paralysis after thyrodectomy
• ability to sign an informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli - IRCCS

Roma, Italy, 00168, Italy

Location

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 27, 2023
• Study Start: July 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: January 1, 2024
• Last Updated: March 12, 2025

Record last verified: 2023-07

Locations

IT (1)