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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05122923
Other study ID # 2019-A00244-53
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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Completed NCT03440580 - BOOSTH: Promoting Physical Activity in Primary Schools in Combination With Serious Gaming N/A