Rehabilitation Methods of Children With Cochlear Implant (MRSI)

November 25, 2024 updated by: mari Giorgia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rehabilitation Methods of Children With Cochlear Implant: a Cross-sectional Survey

The goal of this observational study is to describe the type of the rehabilitation method for italian children with cochlear implant . The main questions are:

What is the most used rehabilitation methods in implanted children? Which is the prevalence of each method related to the clinical features of the patients?

Study Overview

Status

Completed

Conditions

Deafness Neurosensory

Intervention / Treatment

Other: Survey to collect data

Detailed Description

The cochlear implant represents the gold standard in the treatment of children with bilateral severe-profound deafness. However, the current Italian and international guidelines do not address the issue of rehabilitation and how the different rehabilitation methods should be applied in relation to the different clinical pictures. The aim of this study is therefore to describe which methods are used today in the rehabilitation of deaf children with cochlear implants followed at the Phoniatrics and Speech Therapy service of the A. Gemelli Polyclinic Foundation. The creation of a questionnaire directed to the speech therapist who treats the specific patient is available in order to collect data concerning the characteristics of the setting and the rehabilitation method in relation to the most applied methodologies, i.e. Auditory-verbal therapy, oral-cognitive therapy, bimodal method and the Drežančić method.

Inclusion Criteria:

Children diagnosed with severe-profound hearing loss and cochlear implant carriers followed at the Fondazione Policlinico universitario a. Gemelli in the last 10 years;
Age >12 months and <10 years

Exclusion Criteria:

Children diagnosed with mild to moderate hearing loss without a cochlear implant;
Age <12 months and >10 years

Outcomes measures

Describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant
Describe the prevalence of the different methodologies in relation to the clinical characteristics of the patients.

Endpoints:

-% distribution of the 4 rehabilitation methods: cognitive oralism, verb-tonal, Auditory-Verbal therapy and bimodal

- % distribution of the 4 rehabilitation methods: cognitive oralism, verbal-tonal, Auditory-Verbal Therapy and bimodal in relation to the clinical characteristics of the patients.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- RM
  - Roma, RM, Italy, 00168
    - Fondazione Policlinico Universitario A. Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Children diagnosed with severe-profound hearing loss and cochlear implant carriers followed at the Fondazione Policlinico Universitario A. Gemelli, Rome

Description

Inclusion Criteria:

Patients diagnosed with severe to profound hearing loss who underwent cochlear implant placement surgery in the last 10 years;
Age >12 months and <10 years

Exclusion Criteria:

Patients diagnosed with mild to moderate hearing loss without a cochlear implant
Age <12 months and >10 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Methods Time Frame: 3 months	Describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence Time Frame: 2 months	Describe the prevalence of the different methodologies in relation to the clinical characteristics of the patients.	2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria