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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05963165
Acronym
ENFP
Enrollment
56
Registered
2023-07-27
Start date
2023-07-01
Completion date
2024-01-01
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Vocal Cord Paralysis

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.

Interventions

BEHAVIORALNon-phonatory exercises

Muscle exercises that favor glottic adduction without vocal emissions

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Degree of glottic closure3 monthsA 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

MeasureTime frameDescription
Acoustic analysis (NHR)3 monthsThrough 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 (Jitter%)3 monthsThrough 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 (Shimmer%)3 monthsThrough 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 (fundamental frequency)3 monthsThrough 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 (Fhigh)3 monthsThrough 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.
Acoustic analysis (intensity)3 monthsThrough 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.
MPT3 monthsthe Maximum Phonatory Time (MPT) will be evaluated on a sustained /a/ (minimum 3 seconds)
Acoustic analysis (Flow)3 monthsThrough 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026