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

NCT05122364 | Unknown DMC

• 1 other identifier: 987321654
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cochlear Implantation; Hearing Loss

Keywords

Cochlear implant; telerehabilitation; telecoaching

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• changes at the Arabic version of Stanford Binet intelligence scale fifth edition (Faraj, 2010)

  changes from Before sessions and after 6 months of sessions

Study Arms (2)

Telerehabilitation group

ACTIVE COMPARATOR

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

Behavioral: Telerehabilitation and telecoaching

Face to Face group

PLACEBO COMPARATOR

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

Telerehabilitation and telecoaching BEHAVIORAL

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

Also known as: Teletherapy

Telerehabilitation group

Face to Face Language sessions BEHAVIORAL

Language sessions Face to Face at sohag phoniatrics unit

Face to Face group

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Faculty of Medicine, 02(093)- 4602963, Egypt

Location

Related 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.

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Ahlam AN Eladawy, professor

  Sohag University

  STUDY CHAIR

• Ahmed EA Gelany, lecturer

  Sohag University

  STUDY DIRECTOR

• Hadeel E Awad, ass.lecturer

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hadeel E awad, ass.lecturer

CONTACT

0201004041505; hadeel.elsayed@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: 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)

Study Record Dates

• First Submitted: October 30, 2021
• First Posted: November 16, 2021
• Study Start: February 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: january 2026 to june 2026
• Access Criteria: emailing the principal investigator

Locations

EG (1)