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

NCT05122923 | Unknown

• 1 other identifier: 2019-A00244-53
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysexecutive Syndrome; Serious Game

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Patients with Serious Game

EXPERIMENTAL

Device: Serious Game S'TIM

Patients without Serious Game

NO INTERVENTION

Interventions

Serious Game S'TIM DEVICE

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

Patients with Serious Game

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Clinique de Provence Bourbonne

Aubagne, 13400, France

RECRUITING

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 17, 2021
• Study Start: December 3, 2020
• Primary Completion: December 3, 2021
• Study Completion: June 3, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

FR (1)