Voice Telerehabilitation

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Completed
• CT.gov ID: NCT05747859
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vocal Fold Palsy	Other: teletherapy

Study Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Voice Telerehabilitation for Patients Affected by Iatrogenic Unilateral Vocal Fold Paralysis: From Necessity to Opportunity in the COVID-19 Time
• Actual Study Start Date: Nov 5, 2021
• Actual Primary Completion Date: Dec 30, 2021
• Actual Study Completion Date: Jan 15, 2022

Outcome Measures

Primary Outcome Measures

1. analysis [1 month]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario A. Gemelli	Roma		Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

• Principal Investigator: Giorgia Mari, SLP MSC, Fondazione Policlinico Universitario A. Gemelli, Rome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: mari Giorgia, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05747859
• Other Study ID Numbers: 4427
• First Posted: Feb 28, 2023
• Last Update Posted: Feb 28, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vocal Cord Paralysis

Study Results

No Results Posted as of Feb 28, 2023