Telerehabilitation & Telecoaching of Parents of Cochlear Implanted Children at Sohag University Hospital

Study Overview
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Brief Summary
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Design online program for language sessions for cochlear implanted children in arabic and monitor its validity and reliability to improve language outcome

Detailed Description
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Design online program for teletherapy and coach parents to improve language of their children with cochlear implant and evaluate language outcome before and after teletherapy and compare it with control group who will take classical face to face sessions

Official Title
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Telerehabilitation and Telecoaching of Parents of Cochlear Implanted Children at Sohag University Hospital

Conditions
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Cochlear Implantation, Hearing Loss

Intervention / Treatment
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* Behavioral: Telerehabilitation and telecoaching
* Behavioral: Face to Face Language sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cochlear implanted children with non verbal intelligence quotient 80 or above parents are compliant to the sessions Exclusion Criteria: cochlear implanted children who have non verbal intelligence quotient less than 80 using the Arabic version of Stanford Binet intelligence scale 5th edition parents are non compliant to sessions

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups of cochlear implanted children one group will take sessions online (case group) and the other group will take sessions face to face (control group)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telerehabilitation group<br>Group of cochlear implanted children who will take sessions online by the Arabic online program that will be designed | Behavioral: Telerehabilitation and telecoaching<br>* Language Sessions online and coaching parents online to improve language and social outcomes of their children<br>* Other names: Teletherapy;|
| Placebo Comparator: Face to Face group<br>Group of cochlear implanted children who will take sessions face to face in the classical way (control group) | Behavioral: Face to Face Language sessions<br>* Language sessions Face to Face at sohag phoniatrics unit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes at Sohag university hospital protocol for hearing impaired children | Measurement of changes at receptive (0 - 94) and expressive (0-94) language scores and auditory score (0 - 28) higher scores means better outcomes (El-Adawy et al., 2020) | changes from Before sessions and after 3months and 6months of sessions | 
| changes at Preschool language scale four | changes at Receptive raw score (0-62) and expressive language raw score (0-71) and total raw score (0-133) and receptive standard score (43-106), expressive standard score (42-115) and total standard score (55- 115) higher scores means better outcomes (El Sady et al., 2011) | changes from Before sessions and after 3 months and 6 months of sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes at the Arabic version of Stanford Binet intelligence scale fifth edition (Faraj, 2010) | Intelligence quotient measure score (50- 160) higher scores means better outcomes | changes from Before sessions and after 6 months of sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telecoaching, Cochlear implant, telerehabilitation