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

Primary Purpose

Unilateral Vocal Cord Paralysis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non-phonatory exercises
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Vocal Cord Paralysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fondazione Policlinico Universitario A. Gemelli - IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acoustic analysis (fundamental frequency)
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)
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 (Jitter%)
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 (Shimmer%)
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 (Flow)
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)
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.
Acoustic analysis (intensity)
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.
MPT
the Maximum Phonatory Time (MPT) will be evaluated on a sustained /a/ (minimum 3 seconds)

Full Information

First Posted
July 4, 2023
Last Updated
July 18, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05963165
Brief Title
Non-phonatory Exercises in Patients With Unilateral Vocal Fold Paralysis Post-thyroidectomy
Acronym
ENFP
Official Title
Early Speech Therapy Using Non-phonatory Exercises in Patients With Unilateral Vocal Fols Paralysis After Thyroidectomy: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Vocal Cord Paralysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients who will perform non-phonatory exercises in parallel with medical therapy for the first week
Arm Title
Control group
Arm Type
No Intervention
Arm Description
patients who will perform standard medical therapy only during the first week.
Intervention Type
Behavioral
Intervention Name(s)
Non-phonatory exercises
Intervention Description
Muscle exercises that favor glottic adduction without vocal emissions
Primary Outcome Measure Information:
Title
Degree of glottic closure
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Acoustic analysis (fundamental frequency)
Description
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.
Time Frame
3 months
Title
Acoustic analysis (NHR)
Description
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.
Time Frame
3 months
Title
Acoustic analysis (Jitter%)
Description
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.
Time Frame
3 months
Title
Acoustic analysis (Shimmer%)
Description
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
Time Frame
3 months
Title
Acoustic analysis (Flow)
Description
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.
Time Frame
3 months
Title
Acoustic analysis (Fhigh)
Description
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.
Time Frame
3 months
Title
Acoustic analysis (intensity)
Description
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.
Time Frame
3 months
Title
MPT
Description
the Maximum Phonatory Time (MPT) will be evaluated on a sustained /a/ (minimum 3 seconds)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia D'Alatri, MD
Phone
0630155193
Ext
+39
Email
lucia.dalatri@policlinicogemelli.it
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli - IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia D'Alatri, MD
Phone
0630155193
Ext
+39
Email
lucia.dalatri@policlinicogemelli.it

12. IPD Sharing Statement

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

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