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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05122364
• Other study ID #: 987321654
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2022
• Est. completion date: September 2024

Study information

• Verified date: November 2021
• Source: Sohag University
• Contact: hadeel E awad, ass.lecturer
• Phone: 0201004041505
• Email: hadeel.elsayed[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implantation
• Hearing Loss

Intervention

Behavioral:
• Telerehabilitation and telecoaching
Language Sessions online and coaching parents online to improve language and social outcomes of their children
• Face to Face Language sessions
Language sessions Face to Face at sohag phoniatrics unit

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag	Faculty Of Medicine

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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