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

Официальное название

Evaluation of the Effect of Digital-based Games on the Visual and Cognitive Performance of Young Children With Intellectual Disabilities: A Randomized Controlled Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• Severe intellectual disability
• Visual or hearing impairment
• Any medical condition preventing participation
• Lack of participant or parental consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• EÇADEM — Istanbul

Идентификаторы

NCT: NCT07476092 · 2024.391.IRB2.173

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗