NCT05747859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

February 15, 2023

Last Update Submit

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

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli

Roma, 00168, Italy

Location

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

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

Primary Completion

December 30, 2021

Study Completion

January 15, 2022

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)