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临床试验/NCT01596205
NCT01596205已完成不适用

The Efficacy of Robot Assisted Group Cognitive Training in Elderly Adults Without Cognitive Impairment

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2011年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
the change in cortical thickness between the baseline and the post-intervention assessment.

研究概览

简要总结

Previous studies about cognitive intervention targeting older adults revealed that cognitive training had effects on the improvement of cognitive function.However, researches are rare that investigated direct changes of brain structures after cognitive training.

The advanced scientific technique allowed us to develop service robots designed to assist human work, which can be important with an increase in the aging population and high costs of elderly care. In this regard, the investigators considered robots for elderly's cognitive training and developed 17 cognitive programs in collaboration with Center for Intelligent Robotics at Korea Institute of Science and Technology.

The purposes of this study were to demonstrate the effects of the investigators newly developed robot assisted group cognitive training programs on the brain in older adults and to identify whether they can help to improve cognitive function or mood in the elderly compared to the conventional cognitive training or control group that were not involved in any cognitive training.

详细描述

Primary outcome The primary outcome of this study was the change in cortical thickness between the baseline and the post-intervention assessment.

Secondary outcomes Change in the brain functional network from the baseline to the postintervention assessment was also assessed as a secondary outcome ascertained by the analysis of resting state fMRI, which has been used to show correlated spontaneous activity within cortical and subcortical regions that are functionally related.

Further secondary outcomes were changes between the baseline and the post-intervention assessment on cognitive function measured by validated neuropsychological tests such as SNSB and CANTAB on participants' depressive and anxiety symptoms scored by Geriatric Depression Scale and Geriatric Anxiety Inventory respectively, on self reported memory problems measured by Korean Dementia Screenng Questionnaire, Multifactorial Memory Questionnaire and Prospective and Retrospective Memory Questionnaire, on functions of daily living acitivity measured by Bayer ADL, on quality of life measuared by WHOQOL-bref.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •community-dwelling volunteers aged 60 years or older
  • •without dementia
  • •MMSE=26 or above

排除标准

  • •if they had known dementia or significant cognitive impairment accompanied by dysfunction of daily living activities;
  • •had 6 years of education or under;
  • •were illiterate
  • •were unavailable during the testing and intervention periods of the study;
  • •had severe losses in vision or hearing; had major neurological or psychiatric illness history including any history of stroke, transient ischemic attack or traumatic brain injury;
  • •had a medication history which might affect on cognitive function such as acetylcholinesterase inhibitor or memantine
  • •had medical problems such as thyroid, liver and renal disease;
  • •had a significan structural abnormalities on their baseline brain MRI.

研究组 & 干预措施

Control group

No Intervention

Robot intervention

Experimental

Participants were given baseline assessments and randomly assigned into 3 groups; 24 with robot assisted cognitive training group (Robot intervention group), 24 with experienced behavioral therapist group (Conventional intervention group), and 37 without cognitive training (Control group).It was explained that there was a waiting list, therefore, participants in control group had an opportunity to participate in cognitive training program after a delay of 12 weeks for the intervention.

干预措施: Robot assisted cognitive training (Behavioral)

Conventional intervention

Active Comparator

conventional cognitive training group - pen and pencil with experienced behavioral therapists

干预措施: Conventional cognitive training group (Behavioral)

结局指标

主要结局

the change in cortical thickness between the baseline and the post-intervention assessment.

时间窗: between the baseline and the post-intervention assessment (12 week training)

The primary outcome of this study was the change in cortical thickness between the baseline and the post-intervention assessment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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