MRSI: Rehabilitation Methods of Children With Cochlear Implant

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05942261

Collaborator

(none)

Enrollment

Location

7.7

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The cochlear implant represents the gold standard in the treatment of children with bilateral severe-profound deafness. However, the current Italian and international guidelines (JCIH, 2007: Berrettini et al, 2011) 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.

Condition or Disease	Intervention/Treatment	Phase
Deafness Neurosensory	Other: Survey to collect data

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

May 9, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Outcome Measures

Primary Outcome Measures

Methods [3 months]
Describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant.

Secondary Outcome Measures

Prevalence [2 months]
Describe the prevalence of the different methodologies in relation to the clinical characteristics of the patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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