NCT05017051

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 442 (estimated)
• Sponsor: Direction Centrale du Service de Santé des Armées · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dysexecutive Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	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)).
BEHAVIORAL	Lego model	The participants will have to build a Lego model at 4 visits (M0, M12, M24 and M36).
DEVICE	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).
OTHER	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).

Timeline

• Start date: 2021-10-13
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2021-08-23
• Last updated: 2022-12-21

Locations

1 site across 1 country: France