NCT04595552

Brief Summary

The aim of this work is to assess language development in cochlear implanted children in Assiut university hospital and to assess the impact of some related factors (age of implantation, family motivation and education, age of hearing loss and the pre-implanted language therapy or pre-implanted hearing aid wearing) on this development. Adoption of newborn hearing screening programs across the nations has resulted in early identification and confirmation of hearing losses in youngest and vulnerable populations. Early identification often results in early intervention using hearing technology assistance via hearing aids or cochlear implants, parental education programs, and speech-language therapy The major goal of intervention is to capitalize on providing sensory, motor, and interactive exchanges at the earliest stages of communication development as a means of reducing the deleterious effects of auditory deprivation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

3.3 years

First QC Date

September 25, 2020

Last Update Submit

October 14, 2020

Conditions

LanguageDevelopment

Keywords

languagecochlearimplant

Outcome Measures

Primary Outcomes (3)

  • assessment of expressive language in cochlear implant children

    expressive language score in The Arabic language test scale prepared by Nahla Abd Elaziz Refaey 2004 in continuous number, higher value 100 and lower value 0, higher value is better outcome

    pre therapy

  • assessment of receptive language in cochlear implant children

    receptive language score in The Arabic language test scale prepared by Nahla Abd Elaziz Refaey 2004 in continuous number, higher value 100 and lower value 0, higher value is better outcome

    pre therapy

  • semantics score in language test in The continuous number

    semantics score in The Arabic language test scale prepared by Nahla Abd Elaziz Refaey 2004 in continuous number, higher value 100 and lower value 0, higher value is better outcome

    pre therapy

Secondary Outcomes (3)

  • assessment of expressive language in cochlear implant children

    An average of 1 year post therapy

  • assessment of receptive language in cochlear implant children

    An average of 1 year post therapy

  • semantics score in language test in continuous number

    An average of 1 year post therapy

Study Arms (1)

Study group

EXPERIMENTAL

Children with cochlear implant were given Auditory training and language therapy

Other: language therapy

Interventions

language therapyOTHER

auditory training and language therapy for 6 months up to 2 years in 2 session per week the duration of session 30 minuets

Study group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All these patients have satisfactory threshold of hearing post operatively proved by full post-operative audiological evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medecine

Asyut, Egypt

Location

Related Publications (3)

  • Levitt H, McGarr N, Geffner D. Development of language and communication skills in hearing-impaired children. Introduction. ASHA Monogr. 1987 Oct;(26):1-8. No abstract available.

    PMID: 3509663BACKGROUND

  • Moeller MP, Osberger MJ, Eccarius M. Language and learning skills of hearing-impaired students. Receptive language skills. ASHA Monogr. 1986 Mar;(23):41-53. No abstract available.

    PMID: 3730031BACKGROUND

  • Osberger MJ, Moeller MP, Eccarius M, Robbins AM, Johnson D. Language and learning skills of hearing-impaired students. Expressive language skills. ASHA Monogr. 1986 Mar;(23):54-65. No abstract available.

    PMID: 3730032BACKGROUND

MeSH Terms

Conditions

Language

Interventions

Language Therapy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Abdallah Abdelzaher, Dr

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: interventional prospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal invistegator

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 20, 2020

Study Start

July 1, 2016

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations

EG(1)