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临床试验/NCT04070625
NCT04070625已完成不适用

Evaluation of the Effectiveness of a Communication Book in Pragmatic Communication in Vascular Aphasics During the First Year Post-Stroke

University Hospital, Bordeaux0 个研究点目标入组 34 人开始时间: 2009年2月17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
34
主要终点
Number of successful tasks in the communication book

研究概览

简要总结

This study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias.

详细描述

Data from the literature have demonstrated the effectiveness of speech therapy in aphasic vascular. In the face of sequelae, particularly in the most serious aphasia, a palliative approach aims to increase the functional effectiveness of communication in everyday life. The communication book has been developed in this perspective, addressing aphasics whose language communication skills are greatly reduced. Early use in this trial is warranted by implantation prior to the onset of potentially deleterious compensatory mechanisms seen in the late-stage aphasic sequelae.

This study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Informed consent after information. Information is also given to the person of trust when it exists.
  • aphasic subjects admitted to hospital or seen in consultation following a 1st ischemic or hemorrhagic symptomatic vascular accident constituted
  • during the first year of onset of aphasia
  • adults over 18 years old
  • phasic disorder of severe severity expression (overall severity score between 0 and 2 at the diagnostic battery for the assessment of aphasia scale)
  • residual ability to understand clinical assessments and informed consent; information about the objectives and the procedure of the research will also be given to the patient's designated confidant
  • motor capacity for comfortable sitting and transfers with help
  • affiliation to health insurance
  • no deficits in visual perceptual tests (researched using the visual decision of objects and Montreal protocol for the evaluation of visual gnosis), which allows the use of the communication book,

排除标准

  • refusal or impossibility of consent
  • disturbance of vigilance
  • insane state
  • psychiatric history requiring hospitalization in a specialized environment
  • perceptual disturbance, visual agnosia not allowing the use of the image support
  • pregnancy or breastfeeding
  • administration after the occurrence of stroke of a product for which an effect on the recovery of aphasia has been reported: piracetam, bromocriptine, donepezil, dextroamphetamine (if treatment with these products has been performed, inclusion is possible after a weaning period of 15 days)
  • simultaneous inclusion in another therapeutic protocol of language disorders

结局指标

主要结局

Number of successful tasks in the communication book

时间窗: At Day 90 after stroke

Communication book of Gonzales et al, with 6 tasks

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

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