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Clinical Trials/NCT05122923
NCT05122923UnknownNot Applicable

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

Ramsay Générale de Santé1 site in 1 country80 target enrollmentStarted: December 3, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
80
Locations
1
Primary Endpoint
The effect of using the serious-game S'TIM at 6 weeks in terms of metacognition with the BRIEF-A

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Patients with Serious Game

Experimental

Intervention: Serious Game S'TIM (Device)

Patients without Serious Game

No Intervention

Outcomes

Primary Outcomes

The effect of using the serious-game S'TIM at 6 weeks in terms of metacognition with the BRIEF-A

Time Frame: 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

Time Frame: 6 weeks

Behaviour Rating Inventory of Executive Function, Adult

The effect of using the serious-game S'TIM in terms of cognition

Time Frame: 6 weeks

TAP sub-test ERFC : overall cognitive functions BREF : presence or absence of a cognitive and / or behavioral dysexecutive syndrome

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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