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

Recruiting

• Conditions: Dysexecutive Syndrome
• Interventions: Behavioral: Chocolate cake; Behavioral: Lego model; Device: Measurement of sensorimotor abilities; Other: Measurement of facial expression of emotions

• Registration Number: NCT05017051
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-23
• Study Start: 2021-10-13
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

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

Exclusion Criteria

• Patients

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

• Healthy subjects

  • Neurologic or psychiatric pathology
  • Pregnant or breastfeeding woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dysexecutive patients	Chocolate cake	Patients with dysexecutive syndrome
Dysexecutive patients	Measurement of sensorimotor abilities	Patients with dysexecutive syndrome
Healthy subjects	Measurement of sensorimotor abilities	Healthy subjects to be used as control group
Healthy subjects	Chocolate cake	Healthy subjects to be used as control group
Healthy subjects	Measurement of facial expression of emotions	Healthy subjects to be used as control group
Dysexecutive patients	Lego model	Patients with dysexecutive syndrome
Dysexecutive patients	Measurement of facial expression of emotions	Patients with dysexecutive syndrome
Healthy subjects	Lego model	Healthy subjects to be used as control group

Primary Outcome Measures

Name	Time	Method
Lowest number of errors on the executive tasks over the 4 visits	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.

Secondary Outcome Measures

Name	Time	Method
Lowest number of errors on the Lego model task over the 4 visits	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 the Lego model task at each visit. The lowest number will be retained to compare the 2 groups.
Lowest number of errors on the chocolate cake task over the 4 visits	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 the chocolate cake task at each visit.; The lowest number will be retained to compare the 2 groups.

Trial Locations

Locations (1)

Hôpital d'Instruction des Armées Percy; 🇫🇷 Clamart, France