跳至主要内容
临床试验/NCT05017051
NCT05017051招募中不适用

Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients

Direction Centrale du Service de Santé des Armées1 个研究点 分布在 1 个国家目标入组 442 人开始时间: 2021年10月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
442
试验地点
1
主要终点
Lowest number of errors on the executive tasks over the 4 visits

研究概览

简要总结

Executive functions are defined as the mental functions necessary for an individual to adapt to a complex or new environment that requires freedom from automatic and routine behavior. Deficits in executive functions are described under the term "dysexecutive syndrome", and call into question the quality of social and professional life as well as the autonomy of patients.

The usual methods of identifying dysexecutive syndrome are based essentially on batteries of neuropsychological tests known as "paper and pencil". However, these tests may lack sensitivity, in that they assess the patient in a very structured setting, very different from real life conditions, which are full of distractions and choices to be made.

Evaluations on real tasks are more rarely used but have the advantage of observing the difficulties encountered by a patient in everyday life.

Two tests of this type have been set up in the Neurology Department of the Hôpital d'Instruction des Armées Percy, and are integrated into the routine care of patients with a dysexecutive syndrome.

For this purpose, a room in the department has been set up as a studio in order to reproduce as much as possible an everyday life environment, in which executive functions, fine motor skills, neurovegetative functions, emotional state, posture, locomotor skills and visual information capture can be measured ecologically.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Patients with a dysexecutive syndrome OR healthy subjects
  • Over 18 years-old

排除标准

  • Psychiatric pathology (except for Post-Traumatic Stress Disorder)
  • Pregnant or breastfeeding woman
  • Healthy subjects
  • Neurologic or psychiatric pathology
  • Pregnant or breastfeeding woman

结局指标

主要结局

Lowest number of errors on the executive tasks over the 4 visits

时间窗: Until the end of the study (3 years)

An error is defined as: an omission, an addition, a substitution, an estimation error, a question or a commentary The number of errors will be calculated for each task at each visit. The lowest number will be retained to compare the 2 groups.

次要结局

  • Lowest number of errors on the Lego model task over the 4 visits(Until the end of the study (3 years))
  • Lowest number of errors on the chocolate cake task over the 4 visits(Until the end of the study (3 years))

研究者

发起方
Direction Centrale du Service de Santé des Armées
申办方类型
Other
责任方
Sponsor

研究点 (1)

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