Voice Telerehabilitation

Vocal Fold Palsy Clinical Trial

Official title:

Voice Telerehabilitation for Patients Affected by Iatrogenic Unilateral Vocal Fold Paralysis: From Necessity to Opportunity in the COVID-19 Time

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747859
• Other study ID #: 4427
• Status: Completed
• Start date: November 5, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: July 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study was to determine functional results of telerehabilitation (TR) in subjects affected by iatrogenic unilateral vocal fold paralysis (UVFP) during the COVID-19 pandemic outbreak. 40 patients with iatrogenic unilateral vocal fold paralysis underwent voice teletherapy with a synchronous approach. A multidimensional assessment by means of videolaryngostroboscopy, acoustic and perceptual analysis and patient self-assessment was carried out before, at the end of teletherapy and six months later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 15, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age between 18-75 years
• onset of UVFP less than 1 month before
• internet access
• availability and ability to use a computer with an internal or external webcam.

Exclusion Criteria:

• previous history of laryngeal pulmonary or gastric surgery
• current or previous pulmonary diseases
• hearing loss, neurological or motor deficits
• reading difficulties
• dysphagia
• unavailability of a computer and a webcam.

Related Conditions & MeSH terms

• Vocal Cord Paralysis
• Vocal Fold Palsy

Intervention

Other:
• teletherapy
speech therapy remotely delivered

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analysis	to analyze the functional outcomes achieved by a group of patients with recent onset of iatrogenic UVFP who were referred to TR using a synchronous approach.	1 month