- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07476092
Evaluation of the Effect of Digital-based Games on the Visual and Cognitive Performance of Young Children With Intellectual Disabilities
Evaluation of the Effect of Digital-based Games on the Visual and Cognitive Performance of Young Children With Intellectual Disabilities: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Enes Şimşek, MSc. PhD(c)
- Phone Number: +90 5462502050
- Email: enessimsek19@ku.edu.tr
Study Contact Backup
- Name: Remziye Semerci-Şahin, Assistant professor
- Phone Number: +90 5350112821
- Email: remziyesemerci@gmail.com
Study Locations
-
-
Türkiye
-
Istanbul, Türkiye, Turkey (Türkiye)
- Recruiting
- EÇADEM
-
Contact:
- Nihan Yurdadön, MSc.
- Phone Number: +90 5074343362
- Email: nyurdadon@ku.edu.tr
-
Contact:
- İpek Bertan, MSc.
- Phone Number: +90 5413300220
- Email: ibertan@ku.edu.tr
-
Principal Investigator:
- Nihan Yurdadön, MSc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged 18-35 years
- Diagnosed with mild or moderate intellectual disability
- Receiving services from EÇADEM
- Ability to participate in cognitive activities
- Written consent from parents/guardians
- No visual or hearing impairment
- No severe motor coordination problems
Exclusion Criteria:
- Severe intellectual disability
- Visual or hearing impairment
- Any medical condition preventing participation
- Lack of participant or parental consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Digital Intelligence Game Intervention
Participants will receive digital intelligence game training using the MentalUP platform under supervision of a clinical psychologist and occupational therapist.
Sessions will be conducted twice weekly and include structured cognitive exercises targeting attention, memory, and problem-solving skills.
|
MentalUP is a digital cognitive training platform designed to improve attention, memory, logical reasoning, and problem-solving abilities through adaptive intelligence games.
|
|
No Intervention: Routine Care
Participants will receive routine services provided by EÇADEM without additional digital cognitive training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in visual memory performance
Time Frame: Baseline, 3 months, 6 months, and 12 months
|
Visual memory performance will be assessed using the Benton Visual Retention Test (BVRT).
The BVRT evaluates visual perception, visual memory, and visuoconstructive abilities by asking participants to identify previously presented geometric figures.
Scores range from 0 to 15, with higher scores indicating better visual memory performance.
|
Baseline, 3 months, 6 months, and 12 months
|
|
Change in cognitive performance
Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline.
|
Cognitive performance will be evaluated using the Standardized Mini Mental Test (SMMT).
The SMMT assesses orientation, attention, memory, language, and visuospatial abilities.
Scores range from 0 to 30, with higher scores indicating better cognitive functioning.
|
Baseline, 3 months, 6 months, and 12 months after baseline.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Remziye Semerci-Şahin, Assistant professor, Koc University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024.391.IRB2.173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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