Cochlear ImplantationNCT05122364
Telerehabilitation & Telecoaching of Parents of Cochlear Implanted Children at Sohag University Hospital
A study testing Telerehabilitation and telecoaching and Face to Face Language sessions in people with Cochlear Implantation and Hearing Loss, run by Sohag University at 1 site in Egypt.
Trial summary
Design online program for language sessions for cochlear implanted children in arabic and monitor its validity and reliability to improve language outcome Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Cochlear Implantation, Hearing Loss
- What is being tested?
- Telerehabilitation and telecoaching and Face to Face Language sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cochlear implanted children with non verbal intelligence quotient 80 or above
- parents are compliant to the sessions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Sohag University
Sohag, Faculty of Medicine, 02(093)- 4602963
faculty of medicine, 02(093)- 4602963, portal@med.sohag.edu.eg
Medical research ethics committee, ethics@med.sohag.edu.eg
About this study
Official title: 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
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
- Conditions
- Cochlear Implantation, Hearing Loss
- Being tested
- Telerehabilitation and telecoaching, Face to Face Language sessions
- Keywords
- Cochlear implant, telerehabilitation, telecoaching
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation and telecoachingBehavioural
Also called Teletherapy
Language Sessions online and coaching parents online to improve language and social outcomes of their children
Face to Face Language sessionsBehavioural
Language sessions Face to Face at sohag phoniatrics unit
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Active comparator | Group of cochlear implanted children who will take sessions online by the Arabic online program that will be designed Receives: 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) Receives: Behavioral: Face to Face Language sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: changes from Before sessions and after 6 months of sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study startFeb 2022 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cochlear ImplantationStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hadeel elsayed awad, Sohag University
- Investigators
- Ahlam AN Eladawy, professor, Study chair, Sohag UniversityAhmed EA Gelany, lecturer, Study director, Sohag UniversityHadeel E Awad, ass.lecturer, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122364
- Sponsor's protocol ID
- 987321654
- Status last verified
- Nov 2021
- First submitted
- 30 Oct 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol
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 at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation and Telecoaching of Parents of Cochlear Implanted Children at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05122364
- Acronym / sponsor ID
- 987321654
- Conditions
- Cochlear Implantation, Hearing Loss
- Keywords
- Cochlear implant, telerehabilitation, telecoaching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Active comparator | Behavioral: Telerehabilitation and telecoachingGroup of cochlear implanted children who will take sessions online by the Arabic online program that will be designed |
| Face to Face group | Placebo comparator | Behavioral: Face to Face Language sessionsGroup of cochlear implanted children who will take sessions face to face in the classical way (control group) |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Cochlear implanted children with non verbal intelligence quotient 80 or above
- parents are compliant to the sessions
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation and telecoachingAlso: TeletherapyLanguage Sessions online and coaching parents online to improve language and social outcomes of their children | Behavioural | Telerehabilitation group |
| Face to Face Language sessionsLanguage sessions Face to Face at sohag phoniatrics unit | Behavioural | Face to Face group |
Primary outcome
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 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)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- BackgroundEl-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.
- BackgroundEl-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.
- BackgroundFaraj, S., (2010): Stanford-Binet Intelligence Scales (SB5), Fifth Edition. Cairo: the Anglo Egyptian Bookshop.
- Individual participant dataSharing planned: Yes. study protocol
Related trials for Cochlear Implantation
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Recruiting
Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
Cochlear Implant Users
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and telecoaching and Face to Face Language sessions in people with Cochlear Implantation and Hearing Loss, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hadeel E awad, ass.lecturer (0201004041505, hadeel.elsayed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes at Sohag university hospital protocol for hearing impaired children (time frame: changes from Before sessions and after 3months and 6months of sessions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05122364, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.