Intellectual DisabilityNCT07476092
Evaluation of the Effect of Digital-based Games on the Visual and Cognitive Performance of Young Children With Intellectual Disabilities
A study testing MentalUP Digital Intelligence Game in people with Intellectual Disability, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- MentalUP Digital Intelligence Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Severe intellectual disability
- Visual or hearing impairment
- Any medical condition preventing participation
- Lack of participant or parental consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
EÇADEM
Istanbul, Türkiye
Nihan Yurdadön, MSc., +90 5074343362, nyurdadon@ku.edu.tr
İpek Bertan, MSc., +90 5413300220, ibertan@ku.edu.tr
About this study
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
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.
Read the 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.
- Conditions
- Intellectual Disability
- Being tested
- MentalUP Digital Intelligence Game
- Keywords
- Intellectual Disability, Cognitive Performance, Visual Memory, Digital Intelligence Games, Randomized Controlled Trial, MentalUP
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MentalUP Digital Intelligence GameBehavioural
MentalUP is a digital cognitive training platform designed to improve attention, memory, logical reasoning, and problem-solving abilities through adaptive intelligence games.
| Study group | Role | What they receive |
|---|---|---|
| Digital Intelligence Game Intervention | Experimental | 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. Receives: Behavioral: MentalUP Digital Intelligence Game |
| Routine Care | No intervention | Participants will receive routine services provided by EÇADEM without additional digital cognitive training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual memory performance
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.
Measured: Baseline, 3 months, 6 months, and 12 months
Change in cognitive performance
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.
Measured: Baseline, 3 months, 6 months, and 12 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Jun 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Semahat Arsel Nursing Education, Practice and Research Center (SANERC)
- Responsible party
- Principal investigator, Enes Simsek, Koç University
- Investigators
- Remziye Semerci-Şahin, Assistant professor, Study director, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476092
- Sponsor's protocol ID
- 2024.391.IRB2.173
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical considerations and the need to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07476092
- Acronym / sponsor ID
- 2024.391.IRB2.173
- Conditions
- Intellectual Disability
- Keywords
- Intellectual Disability, Cognitive Performance, Visual Memory, Digital Intelligence Games, Randomized Controlled Trial, MentalUP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Semahat Arsel Nursing Education, Practice and Research Center (SANERC)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 17 Mar 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Intelligence Game Intervention | Experimental | Behavioral: MentalUP Digital Intelligence GameParticipants 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. |
| Routine Care | No intervention | –Participants will receive routine services provided by EÇADEM without additional digital cognitive training. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Severe intellectual disability
- Visual or hearing impairment
- Any medical condition preventing participation
- Lack of participant or parental consent
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 |
|---|---|---|
| MentalUP Digital Intelligence GameMentalUP is a digital cognitive training platform designed to improve attention, memory, logical reasoning, and problem-solving abilities through adaptive intelligence games. | Behavioural | Digital Intelligence Game Intervention |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical considerations and the need to protect participant confidentiality.
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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.
Remziye Semerci-Şahin, Assistant professor study director
Koç 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 MentalUP Digital Intelligence Game in people with Intellectual Disability, run by Koç University at 1 site in Turkey (Türkiye).
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. 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 Turkey (Türkiye). 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Remziye Semerci-Şahin, Assistant professor (+90 5350112821, remziyesemerci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual memory performance (time frame: Baseline, 3 months, 6 months, and 12 months). 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?
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 5 Aug 2026.