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NCT Number: NCT05017051

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital d'Instruction des Armées Percy

Clamart, 92140, France

Location status: Recruiting

Location contact

Flavie BOMPAIRE, MD

CONTACT

[email protected]

141466877 ext. +33

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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 outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Flavie BOMPAIRE, MD

CONTACT

[email protected]

141466877 ext. +33

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: SDS2

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Aug 23, 2021
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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