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临床试验/NCT02496312
NCT02496312已完成不适用

Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated in Healthy Subjects and Patients With Frontotemporal Dementia. Pilot Phase.

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2015年7月10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
发起方
入组人数
14
试验地点
1
主要终点
Steps

研究概览

简要总结

The purpose of this study is to provide relevant quantitative evaluation of apathy close to real life situation by means of a multimodal sensor system integrated.

详细描述

The investigators try to measure the amount of goal-directed behaviour and to detect the pattern of apathy. The main objective of this pilot phase is to select the variables of goal-directed behaviour from the list of metrics providing by the multimodal acquisition system in healthy subjects and patients with frontotemporal dementia.

研究设计

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

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Frontotemporal Dementia (FTD) according to diagnostic criteria reported by Rascovsky et al. (2011).
  • Understanding of the instructions and capacity to realize the cognitive tasks.
  • Capacity to read, to understand and to sign legal document of information
  • Capacity for informed consent for research, capacity to sign consent
  • MMSE score > 20
  • Absence of other cerebral pathology.
  • Absence of psychiatric disease interfering with the assessment of the tests
  • Absence of excessive psychotropic use
  • Access to National Healthcare Insurance
  • Accompanied with a caregiver

排除标准

  • Excessive psychotropic use
  • Incapacity or refusal to realize the experimental tasks
  • Subject deprived of freedom by an administrative or court order
  • Subject under legal protective measure.
  • Incapacity for informed consent for research
  • Participation in another biomedical research
  • Airway obstruction risk
  • Reduction of activity not attributable to another chronic pathological condition

研究组 & 干预措施

ECOCAPTURE

Experimental

Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.

干预措施: Evaluation of Apathy Close to Real Life Situation (Behavioral)

结局指标

主要结局

Steps

时间窗: 45 mn

\[Provided by the MOVE MOVISENS sensor\] Counting steps.

Activity intensity

时间窗: 45 mn

\[Provided by the MOVE MOVISENS sensor\] g.

Occurrence of each behavior from the ethogram

时间窗: 45 min

\[Provided by the video recording and The Observer NOLDUS software\]

Frequency of each behavior from the ethogram

时间窗: 45 min

\[Provided by the video recording and The Observer NOLDUS software\]

Duration of each behavior from the ethogram

时间窗: 45 mn

\[Provided by the video recording and The Observer NOLDUS software\]

Number of different behaviors

时间窗: 45 mn

\[Provided by the video recording and The Observer NOLDUS software\]

Activity classes

时间窗: 45 mn

\[Provided by the MOVE MOVISENS sensor\] lying, sitting, ...

Body positions

时间窗: 45 mn

\[Provided by the MOVE MOVISENS sensor\] lying left, ...

MET

时间窗: 45 mn

\[Provided by the MOVE MOVISENS sensor\] The Metabolic Equivalent of Task. MET level.

Energy expenditure

时间窗: 45 mn

\[Provided by the MOVE MOVISENS sensor\] kcal.

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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