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

Serious Game Clinical Trial

— S'TIM 1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05122923
• Other study ID #: 2019-A00244-53
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: June 3, 2022

Study information

• Verified date: November 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 3, 2022
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysexecutive Syndrome
• Serious Game

Intervention

Device:
• Serious Game S'TIM
Video Game S'tim : the patient is inside a bedroom and he has to find a friend outside. this game will study the orientation, the memory of the patient

Locations

Country	Name	City	State
France	Clinique de Provence Bourbonne	Aubagne

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

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