Implementation of the S'TIM Serious-Game for Rehabilitation of Dysexecutive Disorders (S'TIM)

Not Applicable

• Conditions: Dysexecutive Syndrome; Serious Game
• Interventions: Device: Serious Game S'TIM

• Registration Number: NCT05122923
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

This study proposes to improve the management of dysexecutive syndrome by a serious game (SG) in addition to the usual management including work in occupational therapy and neuropsychology.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-03
• Status Verified: 2021-11
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Last Update Submitted: 2021-11-05
• Study First Posted: 2021-11-17
• Last Update Posted: 2021-11-17
• Primary Completion: 2021-12-03
• Study Completion: 2022-06-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• French-speaking male or female patient at least 18 years old
• Patient suffering from recent disorders (less than 6 months) of executive functions
• Patient with sufficient mobility of the upper limb (mobility of the dominant upper limb greater than 70 °) to interact with the device.
• Patient affiliated or beneficiary of a social security scheme
• Patient having signed the free and informed consent.

Exclusion Criteria

• Patient participating in another clinical study
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
• Pregnant or breastfeeding woman,
• Patient hospitalized without consent.
• Patient with unstable psychiatric disorders
• Patient with comprehension disorders (alexia, visual agnosia, illiteracy, not understanding the language, etc.)
• Patient with executive function disorders greater than 6 months
• Negligent hemi patient
• Patient not familiar with the French language
• Patient with major neuro-visual disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with Serious Game	Serious Game S'TIM	-

Primary Outcome Measures

Name	Time	Method
The effect of using the serious-game S'TIM at 6 weeks in terms of metacognition with the BRIEF-A	6 weeks	Behaviour Rating Inventory of Executive Function, Adult
The effect of using the serious-game S'TIM at 6 weeks in terms of behavior with BRIEF-A	6 weeks	Behaviour Rating Inventory of Executive Function, Adult
The effect of using the serious-game S'TIM in terms of cognition	6 weeks	TAP sub-test ERFC : overall cognitive functions BREF : presence or absence of a cognitive and / or behavioral dysexecutive syndrome

Trial Locations

Locations (1)

Clinique de Provence Bourbonne; 🇫🇷 Aubagne, France