Cognitive Remediation Virtual Reality Tool a Recovery-oriented Project for People With Mild Cognitive Impairment: a Feasibility Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Side effects; Dropout rates; Proportion of recruited participants among those considered eligible
研究概览
简要总结
The need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the European Union. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI)
详细描述
The European Union emphasizes the need to promote research in active aging trough multidisciplinary and innovative approaches, addressing challenges related to neurodegenerative diseases in old adults. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI).
Methods: A feasibility randomized controlled clinical trial will involve 30 individuals who are over 65 years old, both sex, who have received the diagnosis of MCI, randomly assigned to experimental condition or control group. Both groups will continue to receive standard pharmacological therapy (TAU). The experimental group will undergo a 3-months cognitive remediation program with fully immersive VR with two sessions per week (each session of sixty minutes). The control group will continue with TAU.
Feasibility will be assessed based on tolerability, including dropout rates and acceptability, (proportion of recruited participants among those considered eligible) and side effects. The preliminary measures of effectiveness will be evaluated on cognitive functions, quality of life, biological and social rhythms, anxiety and depressive.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 65 and above, a diagnosis of MCI based on DSM-IV criteria [American Psychiatric Association, 2000]
排除标准
- •failure to meet inclusion criteria, a diagnosis of epilepsy or severe visual impairments due to potential risks associated with extensive virtual reality stimulation, and severe illnesses impeding bi-weekly intervention attendance
结局指标
主要结局
Side effects; Dropout rates; Proportion of recruited participants among those considered eligible
时间窗: T0 (0 weeks); T1 (12 weeks)
Feasibility will be assessed based on tolerability, including dropout rates and acceptability, which considers the proportion of recruited participants among those considered eligible and side effects.
次要结局
- Short Form Health Survey, 12 items (SF-12)(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Addenbrooke's Cognitive Examination (ACE-R)(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Brief Social Rhythms Scale (BSRS)(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Patient Health Questionnaire (PHQ-9)(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Generalized Anxiety Disorder-7 item (GAD-7)(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Matrix test(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Trail Making Test (TMT)(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Stroop Test(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Rey Figure Test(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Frontal Assessment Battery (FAB)(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Rey's Word Test(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Digit Span(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
- Cognitive Estimates Test (CET)(T0 (0 weeks); T1 (12 weeks); T2 (36 weeks); (72 weeks))
研究者
Mauro Giovanni Carta
Principal Investigator
University of Cagliari