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Recruiting NCT07476092

Evaluation of the Effect of Digital-based Games on the Visual and Cognitive Performance of Young Children With Intellectual Disabilities

No phase Interventional Intellectual Disability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MentalUP Digital Intelligence Game.
Who it may be relevant to
Registry conditions: Intellectual Disability. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Behavioral MentalUP Digital Intelligence Game
    MentalUP is a digital cognitive training platform designed to improve attention, memory, logical reasoning, and problem-solving abilities through adaptive intelligence games.

Primary outcome measures

  • Change in visual memory performance [Time frame: Baseline, 3 months, 6 months, and 12 months]
  • Change in cognitive performance [Time frame: Baseline, 3 months, 6 months, and 12 months after baseline.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • EÇADEM — Istanbul

Identifiers

NCT: NCT07476092 · 2024.391.IRB2.173

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗