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临床试验/NCT03712839
NCT03712839已完成不适用

Cognitive and Cerebral Mechanisms of Anosognosia in Patients With Acquired Brain Damage: New Evaluation Strategies Based on Daily Tasks

María Rodríguez Bailón0 个研究点目标入组 48 人开始时间: 2016年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
主要终点
The awareness ADL

研究概览

简要总结

Acquired brain damage patients usually show severe cognitive deficit that alter their performance on every day life activities. Some of them suffer anosognosia and they are not aware of their own limitations. This situation increases disability by producing a large number of unsafe behaviours, caregivers burn-out and impede rehabilitation by affecting patients desire to follow treatment instructions. From disciplines like Neuropsychology, Cognitive Neuroscience or Occupational Therapy, it is considered a crucial issue to investigate the cognitive and neural mechanisms responsible of anosognosia, as well as to increase our knowledge about the most efficient treatments to deal with this phenomenon. The main general objective of this project is to generate and validate a detailed cognitive assessment protocol within the context of ADL to evaluate the different cognitive components of consciousness proposed on the Toglia and Kirk´s model: 1) Offline componente: metacognitive knowledge and 2) Online component: emergent awareness, self-regulation, anticipatory awareness, self-evaluation and updating processes).

详细描述

The proposed protocol is composed by two ecological tools: The Cog-Awareness ADL Scale (ADL scale of metacognitive knowledge) and the Basic and Instrumental ADL performance based test (Awareness ADL), to identify the presence of cognitive deficits and anosognosia in patients with ABI always within the context of everyday life activities. One first specific aim is to test the convergent validity of the two proposed ecological tools with other traditional and validated measures usually used to assess similar cognitive processes and components of self-awareness. The second specific objective is to investigate the external validity of the ecological tools, by testing whether they are able to discriminate between acquired brain damage patients with and without anosognosia and a group of neurologically healthy participants on every component.

After conducting a literature review of the subject we found that this would be the first protocol developed to identify all these components in the same study.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Presence of an acquired brain damage objectively observed with medical reports.
  • Cognitive deficits relative to executive functions and/or memory evaluated by the team of professionals who recruit participants in the hospital.

排除标准

  • Presence of a serious visuoperceptual deficit that makes it difficult to complete the ADL tasks, evaluated by the team of professionals who recruit participants in the hospital.
  • Presence of an understanding deficit (aphasia) evaluated by the team of professionals who recruit participants in the hospital.
  • Presence of spatial neglect evaluated with line cancellation and line bisection tests.
  • Presence of motor deficits in both upper limbs that impedes to complete the ADL tasks.
  • Total score in MMSE<18

结局指标

主要结局

The awareness ADL

时间窗: 30-45 minutes

Participants will be asked to do activities of daily living such as preparing a breakfast or dressing in which measures that evaluate components of anosognosia will be used. In the tasks of ADL conflict situations (and standardized solutions previously defined) and distractor objects will be presented. The total errors committed will be analyzed, as well as those committed only by conflict situations and distractor objects. The percentage of errors detected and corrected errors will be calculated. In addition, anticipatory awareness, self-evaluation and updating processes will be examined.

The Cog-Awareness ADL Scale

时间窗: 10-15 minutes

For the aim of this study, the Cog-Awareness ADL Scale, will have two versions, one to be administered to a direct caregiver and the other to the patient to observe the discrepancy index in relation to functionality-cognition. This tool allow to evaluate eight key cognitive abilities-task: manipulation difficulties, action schema, distraction, substitution, repetition, error detection, problem solving and task self-initiation in the two basic ADL and in the two instrumental ADL (BADL and IADL, respectively) (34 items). Both patients and caregivers must answer how often the patients present this cognitive-functional error in each of the 4 ADLs: 1: never, 2: sometimes, 3: quite often and 4: always. Two indices are calculated, one for BADL and one for IADL, adding all the scores of the two activities of each category among the number of activities answered. Lower punctuation is interpreted with worse results. There are 3 items that your scores should be reversed.

次要结局

  • Rey Auditory Verbal Learning Test(10-15 minutes)
  • Verbal Fluency Test(5 minutes)
  • Mini-Mental State Examination(10 minutes)
  • Line cancellation test(3-5 minutes)
  • INECO Frontal Screening(6-10 minutes)
  • Color trail making(6 minutes)
  • Key search test(2-4 minutes)
  • Line bisection test(3-5 minutes)
  • Patient Competency Rating Scale(6-10 minutes)
  • Weekly Calendar Planning Activity (WCPA)(20 minutes)

研究者

发起方
María Rodríguez Bailón
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

María Rodríguez Bailón

Professor

University of Malaga

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