Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chocolate cake, Lego model, Measurement of sensorimotor abilities, Measurement of facial expression of emotions.
- Who it may be relevant to
- Registry conditions: Dysexecutive Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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).
Primary outcome measures
- Lowest number of errors on the executive tasks over the 4 visits [Time frame: Until the end of the study (3 years)]
Secondary outcome measures (2)
- Lowest number of errors on the Lego model task over the 4 visits [Time frame: Until the end of the study (3 years)]
- Lowest number of errors on the chocolate cake task over the 4 visits [Time frame: Until the end of the study (3 years)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Hôpital d'Instruction des Armées Percy — Clamart
Identifiers
NCT: NCT05017051 · 2018PPRC34 · 2021-A00087-34