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临床试验/NCT03928613
NCT03928613已完成不适用

Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment

Seoul National University Bundang Hospital2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2019年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Change in CERAD-TS1 score

研究概览

简要总结

The purpose of this study is to examine therapeutic efficacy of cognitive Training based on location information and activity in people with mild cognitive impairment

详细描述

  • A single arm, open-label study.
  • Cognitive Training based on location information and activity is consists of both cognitive training and exercise(walking) using objects in the participant's home. The researchers visit the participant's home and find objects that were mainly used in the real life and easy to access (table, computer, television, etc.) and attach the recognition Bluetooth Low Energy(BLE) Tag (sticker integrated). The stickers printed on the tags consist of word categories (eg animals) belonging to a particular category, so as to assist strategic recall in the stepped recall task. The participants follow the instruction from the tablet-based program to perform the task. During performing the cognitive training program, the participants are guided to walk between the tagged objects in their home.
  • The participants are aged over 60 years old and diagnosed with mild cognitive impairment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Aged above 60
  • Confirmed literacy o Diagnosed with mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5.

排除标准

  • Evidence of delirium, confusion
  • Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
  • Evidence of severe cerebrovascular pathology
  • Presence of depressive symptoms that could influence cognitive function
  • Presence of medical comorbidities that could result in any difficulties in study participation

结局指标

主要结局

Change in CERAD-TS1 score

时间窗: baseline and 6 weeks

Total Score of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Assessment Battery (CERAD-TS1) . CERAD-TS1 is generated by simply summing the scores of six tests including the 1) Verbal fluency (range 0-24), 2) Boston naming test (0-15), 3) Word List Memory (0-30), 4) Word List Recall (0-10), 5) Word list recognition (0-10), 6) Constructional Praxis (0-11). The range of CERAD-TS1 score is 0 to 100 points), and the higher score represents the better cognitive function.

次要结局

  • Change in SMCQ score(baseline and 6 weeks)
  • Change in GDS score(baseline and 6 weeks)
  • Change in MMSE score(baseline and 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Won Han

Associate Professor

Seoul National University Bundang Hospital

研究点 (2)

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