Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-04 @ 5:13 PM
Study NCT ID:
NCT05942261
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2023-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation Methods of Children With Cochlear Implant
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Rehabilitation Methods of Children With Cochlear Implant: a Cross-sectional Survey
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRSI
Brief Summary:
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?
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?
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: