Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:04 AM
Study NCT ID:
NCT07476092
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Digital-based Games on the Visual and Cognitive Performance of Young Children With Intellectual Disabilities
Sponsor:
Koç University
Organization:
Study Overview
Official Title:
Evaluation of the Effect of Digital-based Games on the Visual and Cognitive Performance of Young Children With Intellectual Disabilities: A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized controlled trial aims to evaluate the effect of digital intelligence games on visual and cognitive performance in young individuals with intellectual disabilities. Participants aged 18-35 years receiving services from EÇADEM in Istanbul will be randomly assigned to either an intervention group receiving digital intelligence game training using the MentalUP application or a control group receiving routine services. Visual memory and cognitive performance will be assessed using the Benton Visual Retention Test and the Standardized Mini Mental Test at baseline, 3 months, 6 months, and 12 months. The study will investigate the short- and long-term effects of digital cognitive training on visual and cognitive functioning.
Detailed Description:
This study is designed as an experimental, parallel-group, repeated-measures randomized controlled trial. The study aims to examine the effects of digital intelligence games on the visual and cognitive performance of young individuals with intellectual disabilities.
Participants will be recruited from EÇADEM (Engelli Çocuklar Aile Destek Eğitim Merkezi) located in Sarıyer district of Istanbul. Participants meeting the inclusion criteria will be randomly assigned to intervention and control groups using stratified block randomization according to the level of intellectual disability (mild and moderate).
The intervention group will participate in structured digital intelligence game activities using the MentalUP platform, conducted twice weekly under the supervision of a clinical psychologist and an occupational therapist. The control group will receive routine services provided by the center without additional intervention.
Data will be collected at baseline and at 3-, 6-, and 12-month follow-ups using the Benton Visual Retention Test and the Standardized Mini Mental Test. The study will evaluate both short-term and long-term effects of the digital intervention.
The study protocol follows the CONSORT guidelines for randomized controlled trials.
Participants will be recruited from EÇADEM (Engelli Çocuklar Aile Destek Eğitim Merkezi) located in Sarıyer district of Istanbul. Participants meeting the inclusion criteria will be randomly assigned to intervention and control groups using stratified block randomization according to the level of intellectual disability (mild and moderate).
The intervention group will participate in structured digital intelligence game activities using the MentalUP platform, conducted twice weekly under the supervision of a clinical psychologist and an occupational therapist. The control group will receive routine services provided by the center without additional intervention.
Data will be collected at baseline and at 3-, 6-, and 12-month follow-ups using the Benton Visual Retention Test and the Standardized Mini Mental Test. The study will evaluate both short-term and long-term effects of the digital intervention.
The study protocol follows the CONSORT guidelines for randomized controlled trials.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: