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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDirection Centrale du Service de Santé des Armées

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with a dysexecutive syndrome OR healthy subjects

Over 18 years-old

Disqualifiers

Patients

Psychiatric pathology (except for Post-Traumatic Stress Disorder)

Pregnant or breastfeeding woman

Healthy subjects

Trial population

The study population is composed of 2 groups: * a group of patients with dysexecutive syndrome * a group of healthy subjects

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Chocolate cake

    Behavioral

    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)).

  • Lego model

    Behavioral

    The participants will have to build a Lego model at 4 visits (M0, M12, M24 and M36).

  • Measurement of sensorimotor abilities

    Device

    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).

  • Measurement of facial expression of emotions

    Other intervention

    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).

Treatment groups

442 Participants
are divided into 2 treatment groups
Group A: Dysexecutive patients4 interventions
Group B: Healthy subjects4 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Until the end of the study (3 years)

Secondary outcomes

1

Lowest number of errors on the Lego model task over the 4 visits

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.

Time frame
Until the end of the study (3 years)
2

Lowest number of errors on the chocolate cake task over the 4 visits

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.

Time frame
Until the end of the study (3 years)

Other outcomes

Sponsors and contacts

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