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

Primary Purpose

Cochlear Implantation, Hearing Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Telerehabilitation and telecoaching
Face to Face Language sessions
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cochlear Implantation focused on measuring Cochlear implant, telerehabilitation, telecoaching

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sohag University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Telerehabilitation group

Face to Face group

Arm Description

Group of cochlear implanted children who will take sessions online by the Arabic online program that will be designed

Group of cochlear implanted children who will take sessions face to face in the classical way (control group)

Outcomes

Primary Outcome Measures

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 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)

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2021
Last Updated
November 14, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05122364
Brief Title
Telerehabilitation & Telecoaching of Parents of Cochlear Implanted Children at Sohag University Hospital
Official Title
Telerehabilitation and Telecoaching of Parents of Cochlear Implanted Children at Sohag University Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cochlear Implantation, Hearing Loss
Keywords
Cochlear implant, telerehabilitation, telecoaching

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation group
Arm Type
Active Comparator
Arm Description
Group of cochlear implanted children who will take sessions online by the Arabic online program that will be designed
Arm Title
Face to Face group
Arm Type
Placebo Comparator
Arm Description
Group of cochlear implanted children who will take sessions face to face in the classical way (control group)
Intervention Type
Behavioral
Intervention Name(s)
Telerehabilitation and telecoaching
Other Intervention Name(s)
Teletherapy
Intervention Description
Language Sessions online and coaching parents online to improve language and social outcomes of their children
Intervention Type
Behavioral
Intervention Name(s)
Face to Face Language sessions
Intervention Description
Language sessions Face to Face at sohag phoniatrics unit
Primary Outcome Measure Information:
Title
changes at Sohag university hospital protocol for hearing impaired children
Description
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)
Time Frame
changes from Before sessions and after 3months and 6months of sessions
Title
changes at Preschool language scale four
Description
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)
Time Frame
changes from Before sessions and after 3 months and 6 months of sessions
Secondary Outcome Measure Information:
Title
changes at the Arabic version of Stanford Binet intelligence scale fifth edition (Faraj, 2010)
Description
Intelligence quotient measure score (50- 160) higher scores means better outcomes
Time Frame
changes from Before sessions and after 6 months of sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hadeel E awad, ass.lecturer
Phone
0201004041505
Email
hadeel.elsayed@med.sohag.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahlam AN Eladawy, professor
Organizational Affiliation
Sohag University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed EA Gelany, lecturer
Organizational Affiliation
Sohag University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hadeel E Awad, ass.lecturer
Organizational Affiliation
Sohag University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sohag University
City
Sohag
State/Province
Faculty Of Medicine
ZIP/Postal Code
02(093)- 4602963
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
faculty of medicine
Phone
02(093)- 4602963
Email
portal@med.sohag.edu.eg
First Name & Middle Initial & Last Name & Degree
Medical research ethics committee
Email
ethics@med.sohag.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study protocol
IPD Sharing Time Frame
january 2026 to june 2026
IPD Sharing Access Criteria
emailing the principal investigator
Citations:
Citation
El-Adawy, A., Emam, A., Mostafa, E., Gelaney, A. & Awad, H. (2020): Assessment protocol for Auditory and Language Abilities in Cochlear Implanted Children used in Sohag university hospital. Egyptian Journal of Neck Surgery and Otorhinolaryngology, 6(1), 17-36.
Results Reference
background
Citation
El-Sady, S.R., El-Shoubary, A.M., Hafez, G.N. & Abo-Hasseba, A.M. (2011): Translated, modified and standardized Preschool Language Scale [Unpublished Thesis]. 4th ed. Cairo: Ain Shams Medical School.
Results Reference
background
Citation
Faraj, S., (2010): Stanford-Binet Intelligence Scales (SB5), Fifth Edition. Cairo: the Anglo Egyptian Bookshop.
Results Reference
background

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

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