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

R

Ramsay Générale de Santé

Status

Unknown

Conditions

Serious Game
Dysexecutive Syndrome

Treatments

Device: Serious Game S'TIM

Study type

Interventional

Funder types

Other

Identifiers

NCT05122923
2019-A00244-53

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Patients with Serious Game
Experimental group
Treatment:
Device: Serious Game S'TIM
Patients without Serious Game
No Intervention group

Trial contacts and locations

1

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Central trial contact

Jean-François Oudet; Marie-Hélène Barba

Data sourced from clinicaltrials.gov

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