Implementation of the S'TIM Serious-Game for Rehabilitation of Dysexecutive Disorders (S'TIM) (S'TIM 1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Serious Game; Dysexecutive Syndrome
• Intervention / Treatment: Device: Serious Game S'TIM

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aubagne, France, 13400
    • Recruiting
    • Clinique de Provence Bourbonne
    • Contact: Michèle Timsit, Dr; Phone Number: 06.15.31.10.22; Email: m.timsit@ramsaygds.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with Serious Game	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
NO_INTERVENTION: Patients without Serious Game

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2020
• Primary Completion (ANTICIPATED): December 3, 2021
• Study Completion (ANTICIPATED): June 3, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (ACTUAL): November 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019-A00244-53

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No