Effects of a Social Robot Cognitive-Game Intervention in Older Adults With Mild Cognitive Impairment and Dementia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Montreal Cognitive Assessment(MoCA)
研究概览
简要总结
This study aims to evaluate the effects of interactive robot-based games on cognitive function, neuropsychiatric symptoms, and quality of life in patients with mild cognitive impairment and dementia. The investigators plan to recruit 80 participants and randomly assign them to a control group or an experimental group; the experimental group will participate in robot games for 12 weeks, while the control group will receive routine care. Data will be collected via questionnaires to investigate whether robot games can improve cognitive function, neuropsychiatric symptoms, and quality of life in patients with mild cognitive impairment and dementia.
详细描述
This study aims to evaluate the effects of interactive robot games on cognitive function, behavioral and psychological symptoms, and quality of life in patients with mild cognitive impairment and dementia. The investigators plan to recruit 80 participants and randomly assign them to a control group or an experimental group. The experimental group will engage in robot games for 12 weeks, twice weekly, about 20 minutes per session, while the control group will receive usual care. All participants will complete four questionnaire assessments to investigate whether the robot games can improve cognitive function, behavioral and psychological symptoms, and quality of life in patients with mild cognitive impairment and dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50 years or older
- •Diagnosed by a physician with Mild Cognitive Impairment, mild, or moderate dementia
- •Able to communicate in Mandarin or Taiwanese
- •Willing to participate and provides informed consent signed by the participant or their family member/legal representative
排除标准
- •Individuals who experience fear or aversion toward interactive robots or related equipment
- •Individuals with severe hearing or visual impairments that affect participation in activities
- •Individuals unable to complete the entire intervention due to unstable physical or mental conditions
- •Individuals deemed unsuitable for this study by physician assessment
结局指标
主要结局
Montreal Cognitive Assessment(MoCA)
时间窗: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
MoCA is one of the primary assessment indicators that investigators expect to see improved after interactive robot game interventions. The MoCA assessment covers multiple cognitive domains including attention and concentration, executive function, memory, language ability, visuospatial skills, abstract thinking, calculation ability, and orientation. The full score is 30 points, with higher scores indicating better cognitive function.
Neuropsychiatric Inventory Questionnaire(NPI-Q)
时间窗: From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.
NPI-Q is one of the primary evaluation indicators investigators expect to improve after interactive robot game intervention. NPI-Q includes 12 items: delusions, hallucinations, agitation, depression, anxiety, abnormal motor behavior, sleep and nighttime behavior disorders, etc. Each item is scored for severity on a scale of 1-3 points, with higher scores indicating greater severity, and for caregiver distress on a scale of 0-5 points, with higher scores indicating greater distress. The total score is calculated by multiplying the severity and distress scores, with higher scores representing more severe symptoms.
次要结局
- Quality of Life in Alzheimer's Disease(QoL-AD)(From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.)
- Geriatric Depression Scale 15(GDS-15)(From baseline to 12 weeks after the intervention, with follow-up assessments at 1 month and 3 months post-intervention.)