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

NCT05017051 | Recruiting

• 2 other identifiers: 2018PPRC342021-A00087-34
• Study Type: observational
• Target: 442
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysexecutive Syndrome

Outcome Measures

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.

  Until the end of the study (3 years)

Secondary Outcomes (2)

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

  Until the end of the study (3 years)

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

  Until the end of the study (3 years)

Study Arms (2)

Dysexecutive patients

Patients with dysexecutive syndrome

Behavioral: Chocolate cake; Behavioral: Lego model; Device: Measurement of sensorimotor abilities; Other: Measurement of facial expression of emotions

Healthy subjects

Healthy subjects to be used as control group

Behavioral: Chocolate cake; Behavioral: Lego model; Device: Measurement of sensorimotor abilities; Other: Measurement of facial expression of emotions

Interventions

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)).

Dysexecutive patients; Healthy subjects

Lego model BEHAVIORAL

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

Dysexecutive patients; Healthy subjects

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).

Dysexecutive patients; Healthy subjects

Measurement of facial expression of emotions OTHER

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).

Dysexecutive patients; Healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Hôpital d'Instruction des Armées Percy

Clamart, 92140, France

RECRUITING

Central Study Contacts

Flavie BOMPAIRE, MD

CONTACT

141466877; flavie.bompaire@intradef.gouv.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 23, 2021
• Study Start: October 13, 2021
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

FR (1)