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

NCT ID: NCT05963165

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Non-phonatory exercises

Intervention Type: BEHAVIORAL

Muscle exercises that favor glottic adduction without vocal emissions

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Non-phonatory exercises

Muscle exercises that favor glottic adduction without vocal emissions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

D'Alatri Lucia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario A. Gemelli - IRCCS

Roma, Italy, Italy

Countries

Italy

Other Identifiers

5559

Identifier Type: -

Identifier Source: org_study_id