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

November 14, 2021 updated by: hadeel elsayed awad, Sohag University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Faculty Of Medicine
      • Sohag, Faculty Of Medicine, Egypt, 02(093)- 4602963

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Language Sessions online and coaching parents online to improve language and social outcomes of their children
Other Names:
  • Teletherapy
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
Language sessions Face to Face at sohag phoniatrics unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes at Sohag university hospital protocol for hearing impaired children
Time Frame: changes from Before sessions and after 3months and 6months of sessions
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
Time Frame: changes from Before sessions and after 3 months and 6 months of sessions
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)
Time Frame: changes from Before sessions and after 6 months of sessions
Intelligence quotient measure score (50- 160) higher scores means better outcomes
changes from Before sessions and after 6 months of sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Chair: Ahlam AN Eladawy, professor, Sohag University
  • Study Director: Ahmed EA Gelany, lecturer, Sohag University
  • Principal Investigator: Hadeel E Awad, ass.lecturer, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

October 30, 2021

First Submitted That Met QC Criteria

November 14, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 14, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 987321654

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol

IPD Sharing Time Frame

january 2026 to june 2026

IPD Sharing Access Criteria

emailing the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hearing Loss

Clinical Trials on Telerehabilitation and telecoaching

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe