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临床试验/NCT05275153
NCT05275153已完成不适用

Effectiveness of a Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application in Patients With Mild Cognitive Impairment

Pusan National University Yangsan Hospital2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2020年4月22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
50
试验地点
2
主要终点
Change of the Korean-Montreal cognitive assessment(MoCA) score

研究概览

简要总结

In this study, a more specific and systematic Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application is developed and the purpose of the program is to check whether cognitive function is improved when the program is applied to patients with MCI.

详细描述

The subjects of recruitment were the elderly with mild cognitive impairment living in the local community. Assessments were conducted 7 days before and after the intervention. Subjects received Korean-Montreal Cognitive Assessment(MoCA), semantic verbal emory test (SVLT), number memorization test; Digit Span Test (DST), category word fluency test (CWFT), phonemic word fluency test (PWFT), Korean-mini mental state test (K-MMSE), and geriatric depression scale (GDS) before and 8 weeks after the intervention.

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
None

入排标准

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

入选标准

  • Men and women over the age of 55
  • Those who have visual and auditory abilities without difficulties in conducting this research
  • Those with K-MMSE (Korean-Mini Mental State Examination) score of 24 or higher and 16≤K-MoCA score<23
  • In the case of patients taking dementia treatment, those who have the same treatment regimen and dose for 3 months or more from the screening date
  • A person who can understand and respond to the questionnaire questions.
  • A person who voluntarily decided to participate in this study and gave written consent to the informed consent form

排除标准

  • Those with a history of alcohol or drug abuse,
  • Those with a past history of uniaxial psychiatric disorders, including intellectual disability, schizophrenia, alcoholism, and bipolar disorder
  • A person who is unable to communicate
  • Those who show all neurological symptoms that cause cognitive decline, such as Parkinson's disease, cerebral hemorrhage, brain tumor, and hydrocephalus
  • Those with a record of being unconscious for more than 1 hour due to head trauma or mild repetitive head trauma
  • Those with symptoms of depression that may affect cognitive function

结局指标

主要结局

Change of the Korean-Montreal cognitive assessment(MoCA) score

时间窗: Baseline and Week 8

It is a tool to evaluate overall cognitive function. Possible scores range from 0(lowest cognitive function) to 30 (highest cognitive function). Change = Paired t-test with baseline score and week 8 score.

次要结局

  • Change of the semantic verbal emory test (SVLT) score(Baseline and Week 8)
  • Change of the phonemic word fluency test (PWFT) score(Baseline and Week 8)
  • Change of the category word fluency test (CWFT) score(Baseline and Week 8)
  • Change of the Digit Span Test (DST) score(Baseline and Week 8)
  • Change of the geriatric depression scale (GDS) score(Baseline and Week 8)

研究者

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

Yong-il Shin

Professor

Pusan National University Yangsan Hospital

研究点 (2)

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