CClinicalTrials.gg
Status unknownNCT05122364Updated Nov 16, 2021

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

An interventional study of Telerehabilitation and telecoaching and Face to Face Language sessions in Cochlear Implantation and Hearing Loss, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2021-11-16.

Sponsored by Sohag University · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
2 Years to 8 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Cochlear Implantation
  • Hearing Loss

Browse trials for

Keywords

  • Cochlear implant
  • telerehabilitation
  • telecoaching
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cochlear implanted children with non verbal intelligence quotient 80 or above
  • parents are compliant to the sessions

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Telerehabilitation group

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

    Behavioral: Telerehabilitation and telecoaching

  • Placebo comparator
    Face to Face group

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

    Behavioral: Face to Face Language sessions

Interventions

  • BehavioralTelerehabilitation and telecoaching

    Language Sessions online and coaching parents online to improve language and social outcomes of their children

    Also known as: Teletherapy

  • BehavioralFace to Face Language sessions

    Language sessions Face to Face at sohag phoniatrics unit

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: changes from Before sessions and after 3months and 6months of sessions

  2. 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)

    Time frame: changes from Before sessions and after 3 months and 6 months of sessions

Secondary outcomes

  1. 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

    Time frame: changes from Before sessions and after 6 months of sessions

07

Study locations

1 site
08

References and documents

Publications

  • 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.
  • 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.
  • Faraj, S., (2010): Stanford-Binet Intelligence Scales (SB5), Fifth Edition. Cairo: the Anglo Egyptian Bookshop.

Individual participant data

Plan to share: Yes — study protocol

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05122364
Lead sponsor
Sohag University
Responsible party
hadeel elsayed awad (Assistant lecturer, Sohag University) — Principal investigator
First posted
Nov 16, 2021
Start date
Feb 2022 (estimated)
Primary completion
Apr 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Nov 16, 2021

Study contacts

hadeel E awad, ass.lecturer
Contact
hadeel.elsayed@med.sohag.edu.eg
0201004041505
Ahlam AN Eladawy, professor
study chair · Sohag University
Ahmed EA Gelany, lecturer
study director · Sohag University
Hadeel E Awad, ass.lecturer
principal investigator · Sohag University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion