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

Not Applicable
Completed
Conditions
Unilateral Vocal Cord Paralysis
Interventions
Behavioral: Non-phonatory exercises
Registration Number
NCT05963165
Lead Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
56
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental groupNon-phonatory exercisesPatients who will perform non-phonatory exercises in parallel with medical therapy for the first week
Primary Outcome Measures
NameTimeMethod
Degree of glottic closure3 months

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.

Secondary Outcome Measures
NameTimeMethod
Acoustic analysis (fundamental frequency)3 months

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.

Acoustic analysis (NHR)3 months

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.

Acoustic analysis (Shimmer%)3 months

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

Acoustic analysis (Jitter%)3 months

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.

Acoustic analysis (intensity)3 months

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.

Acoustic analysis (Flow)3 months

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.

Acoustic analysis (Fhigh)3 months

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.

MPT3 months

the Maximum Phonatory Time (MPT) will be evaluated on a sustained /a/ (minimum 3 seconds)

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli - IRCCS

🇮🇹

Roma, Italy

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