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Completed

NCT Number: NCT05942261

Rehabilitation Methods of Children With Cochlear Implant

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?

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Key information

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli

Roma, RM, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey to collect data

Other

The study is a survey aimed to collect data about rehabilitation methods

Primary outcomes

  1. Methods

    Time frame: 3 months

    Describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant.

Secondary outcomes

  1. Prevalence

    Time frame: 2 months

    Describe the prevalence of the different methodologies in relation to the clinical characteristics of the patients.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: MRSI

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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