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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Unilateral Vocal Cord Paralysis

Treatments: Behavioral: Non-phonatory exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05963165

5559

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Behavioral: Non-phonatory exercises

Control group

No Intervention group

Description:

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