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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05017051
Acronym
SDS2
Enrollment
442
Registered
2021-08-23
Start date
2021-10-13
Completion date
2028-10-31
Last updated
2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysexecutive Syndrome

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.

Interventions

BEHAVIORALChocolate 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)).

BEHAVIORALLego model

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

DEVICEMeasurement 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).

OTHERMeasurement 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).

Sponsors

Direction Centrale du Service de Santé des Armées
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Lowest number of errors on the executive tasks over the 4 visitsUntil 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

MeasureTime frameDescription
Lowest number of errors on the Lego model task over the 4 visitsUntil 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.
Lowest number of errors on the chocolate cake task over the 4 visitsUntil 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.

Countries

France

Contacts

Primary ContactFlavie BOMPAIRE, MD
flavie.bompaire@intradef.gouv.fr141466877

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026