NCT05747859

Completed

Voice Telerehabilitation

Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source

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Other study identifiers

Sponsor study identifier

4427

Study Type

observational

Actual enrollment (reported)

15

Locations

1 country

Sites

1

Timeline

Study Start

November 5, 2021

Actual (reported)

Primary Completion

December 30, 2021

Actual (reported)

Study Completion

January 15, 2022

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 15 participants
Study completion date: January 15, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 5, 2021
Actual (reported)
Primary Completion
December 30, 2021
Actual (reported)
Study Completion
January 15, 2022
Actual (reported)
First Submitted
February 15, 2023
Actual (reported)
First Posted
February 28, 2023
Actual (reported)

Last Updated: July 6, 2023
Status Verified: July 2023
Last Update Submitted: July 4, 2023

Conditions

Vocal Fold Palsy

Outcome Measures

Primary Outcomes (1)

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

Interventions

teletherapyOther

speech therapy remotely delivered

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

15 subjects affected by permanent iatrogenic UVFP

You may qualify if:

age between 18-75 years

Sponsors & Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Otherlead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli

Roma, 00168, Italy

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Giorgia Mari, SLP MSC
Fondazione Policlinico Universitario A. Gemelli, Rome
PRINCIPAL INVESTIGATOR

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 28, 2023

Study Start

November 5, 2021

Actual (reported)

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Not ApplicableUnknown

onset of UVFP less than 1 month before

internet access

availability and ability to use a computer with an internal or external webcam.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

December 30, 2021

Actual (reported)

Study Completion

January 15, 2022

Actual (reported)

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05747859
Data provider: ClinicalTrials.gov
Source updated: 2023-07-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:08 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations