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

Обзор

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.

Вмешательства

• Поведенческое Chocolate cake
  The participants will have to make a chocolate cake following an imposed recipe at 4 visits (initially (M0), after 12 months (M12), after 24 months (M24) and after 36 months (M36)).
• Поведенческое Lego model
  The participants will have to build a Lego model at 4 visits (M0, M12, M24 and M36).
• Устройство Measurement of sensorimotor abilities
  The measurement of sensorimotor abilities is based on a multi-sensor device called Smart Flat specifically designed for this study at 4 visits (M0, M12, M24 and M36).
• Другое Measurement of facial expression of emotions
  Participants will have to evoke an emotionally charged autobiographical story by modulating facial expressions through a mirror at 4 visits (M0, M12, M24 and M36).

Первичные конечные точки

• Lowest number of errors on the executive tasks over the 4 visits [Срок оценки: Until the end of the study (3 years)]

Вторичные конечные точки (2)

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

Критерии участия

Критерии включения

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

Критерии исключения

• Patients

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

• Neurologic or psychiatric pathology
• Pregnant or breastfeeding woman

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• Hôpital d'Instruction des Armées Percy — Clamart

Идентификаторы

NCT: NCT05017051 · 2018PPRC34 · 2021-A00087-34

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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