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临床试验/NCT01103453
NCT01103453Unknown1 期

Change in Executive Functions and in Instrumental Activities of Daily Living as a Result of Intervention by Virtual Supermarket Environment Among People With Mild Cognitive Impairment.

Carmel Medical Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年11月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
发起方
入组人数
10
试验地点
2
主要终点
Improvement in executive functions by means of comparison to the results on the NexAde® computerized test.

研究概览

简要总结

The aim of the study is to investigate the feasibility of using a virtual supermarket as an intervention tool for overcoming deficits in executive function as well as enhancing IADL performance among persons with Mild Cognitive Impairment. The working hypotheses are that there will be improvement in executive functions, and the improvement in the executive functions will result in better performance in Instrumental Activities of Daily Living, both generally and especially in shopping task

详细描述

Scientific and clinical research in the area of Alzheimer's disease (AD) during the last years have shifted their focus to earlier diagnosis and especially to the transitional phase between normal aging and dementia, named Mild Cognitive Impairment (MCI).Lately, the concept of MCI has been expanded to address observed clinical heterogeneity, and subtypes were recognized: amnestic (including memory impairment) and non-amnestic (including impairment in other non-memory cognitive domains), with the later including deficits in executive functioning Executive functions (EF) are defined as higher order functions that are needed for completing complex or non-routine tasks. Deficits in EF refer to a collection of deficits in attention, planning, problem-solving, multitasking, monitoring and behavioral control and persons who suffer from impairments in EF typically have difficulty in initiating or suspending activities, show impaired mental flexibility, as well as increased distractibility and have difficulty in learning novel tasks despite apparently intact cognitive abilities.

Lately, an increasing amount of studies suggest that persons with MCI might have deficits in EF, moreover, persons presenting a combination of executive deficits and memory deficits were found to be a high risk group for conversion to AD.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed as suffering from MCI
  • No impaired judgement
  • Verbal and written proficiency in Hebrew
  • Normal or corrected-to-normal vision and hearing ability
  • Independent in ADL function
  • Lives in the community
  • Able to perform task of shopping.

排除标准

  • Suffering from other coexistent neurological diseases (e.g. stroke, muscular dystrophy)
  • Has acute arthritis
  • Poorly controlled hypothyroidism
  • Suffering from physical or sensory limitations, as by self-report or noted by the investigator, that may limit the use of a computer's mouse
  • No skills in performing shopping task
  • Defined as suffering from depression as determined by the rating scale for depression
  • Diagnosed as suffering from dementia as defined by Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-IV)

研究组 & 干预措施

Intervention Group

Experimental

Study group are persons diagnosed as suffering from Mild Cognitive Impairment will undergo a series of 9 sessions on a computer program of a virtual supermarket to improve their Executive and IADL functions.

干预措施: Virtual Action Planning Supermarket (VAP-S) Software (Behavioral)

结局指标

主要结局

Improvement in executive functions by means of comparison to the results on the NexAde® computerized test.

时间窗: 1 month after intervention

The NexAde® is a computerized assessment test for deficits in cognition and executive function. The test consists of several neuropsychological tests used in clinical practice and research and the domains being assessed are attention, memory, visuomotor learning, spatial memory, executive function and mental flexibility. The test has been adapted for older adults who are not familiar with computers and was found to be reliable and valid.

次要结局

  • Improved performance in IADL, both generally and especially in shopping task.(1 month after intervention)

研究者

发起方
Carmel Medical Center
申办方类型
Other

研究点 (2)

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