Rehabilitation Methods of Children With Cochlear Implant (MRSI)

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): 30

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

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: July 4, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; cochlear implant; deafness
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: 5685

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No