Towards the Development of a Mobile-health Technology Designed to Encourage the Use of Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Change in Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
This study will evaluate the therapeutic efficacy of Neuro-World cognitive training games (Woorisoft, S. Korea) in patients with mild cognitive impairment.
详细描述
This study will be a cross-over randomized controlled trial.
Fifty participants will be enrolled and randomly assigned to group A or group B.
Group A will self-administer Neuro-World cognitive training games for 30 minutes a day, twice a week for 12 weeks in the home setting (i.e., intervention period). For the following 12 weeks, the participants will not engage in any therapist-supervised cognitive therapies (i.e., no-intervention period).
Group B will not engage in any therapist-supervised cognitive therapies (i.e., no-intervention period). For the following 12 weeks, the participants will self-administer Neuro-World cognitive training games for 30 minutes a day, twice a week in the home setting (i.e., intervention period).
All the participants in both groups will receive phone calls twice a week to 1) provide feedback on their adherence to Neuro-World cognitive training (during the intervention period) and 2) learn any significant changes in the level of their daily activities (during the no-intervention period and the intervention period).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seventeen points or greater and smaller than twenty-six points on the Montreal Cognitive Assessment (MoCA)
- •Fifty-five years old and above
- •Minimal technological literacy (i.e. ability to use a tablet independently)
- •Having a computer for online videoconferencing-based communication (necessary for online cognitive assessments)
排除标准
- •Confounding neurological and psychiatric disorders
- •History of traumatic brain injury
- •Clinically known hearing or vision impairment
- •Severe upper-limb motor impairments that could impact the use of mobile devices
- •Clinical presentations suggestive of dementia with Lewy bodies, progressive supranuclear palsy, multiple system atrophy, or vascular parkinsonism
- •Diagnosis of dementia
- •Major depression
- •Any significant upper-limb impairment that could affect tablet use
- •Participation in any other therapist-supervised cognitive training
结局指标
主要结局
Change in Montreal Cognitive Assessment (MoCA)
时间窗: 12 weeks
MoCA scores range between 0 and 30. Higher scores indicate better cognitive function. The change in MoCA scores was measured from baseline to 12 weeks
次要结局
- Change in Mini-Mental State Examination (MMSE)(12 weeks)
- Change in Digit Forward Span (DFS)(12 weeks)
- Change in Digit Backward Span (DBS)(12 weeks)
- Change in Geriatric Depression Scale (GDS)(12 weeks)
- Change in Short Form 36 (SF-36) Mental Component Summary Score(12 weeks)
- Change in Lawton-Brody Instrumental Activities of Daily Living Scale (IADL)(12 weeks)