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

NCT ID: NCT05122923

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-03

Study Completion Date

2022-06-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysexecutive Syndrome Serious Game

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Serious Game

Group Type EXPERIMENTAL

Serious Game S'TIM

Intervention Type 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 without Serious Game

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinique de Provence Bourbonne

Aubagne, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jean-François Oudet

Role: CONTACT

Phone: 0683346567

Email: [email protected]

Marie-Hélène Barba

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Michèle Timsit, Dr

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A00244-53

Identifier Type: -

Identifier Source: org_study_id