Evaluation of the Effect of Digital-based Games on the Visual and Cognitive Performance of Young Children With Intellectual Disabilities: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in visual memory performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Severe intellectual disability
- •Visual or hearing impairment
- •Any medical condition preventing participation
- •Lack of participant or parental consent
研究组 & 干预措施
Routine Care
Participants will receive routine services provided by EÇADEM without additional digital cognitive training.
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.
干预措施: MentalUP Digital Intelligence Game (Behavioral)
结局指标
主要结局
Change in visual memory performance
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Enes Simsek
MSc. PhD(c)
Koç University