Executive Functions Computerized Rehabilitation Using Virtual Reality to Improve Activities of Daily Living Post-stroke

NCT ID: NCT04855903

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-21
• Study Completion Date: 2025-04-30

Brief Summary

This research aims to evaluate the effects of a cognitive reeducation carried out with the COVIRTUA Cognition software using a virtual environment, on real-life execution of activities of daily living (ADL) for patients with post-stroke dysexecutive disorders. We will assess patients' performances in achieving ADLs by the Goal Attainment Scaling (GAS) throughout the follow-up (3 months), based on the goals set at the beginning of management with each patient.

Detailed Description

Many post-stroke patients, especially those with frontal lobe lesions, have chronic impairments in mental flexibility, leading to difficulties in decision-making, action planning, or behavioural perseverance. Techniques for remediation of these dysexecutive disorders are often performed in a hospital or in a liberal office. The possible progress resulting from this rehabilitation is rarely transposed into the patient daily life performances, executed in a richer and less controlled environment than the usual place of re-educational. Here, we wish to assess the effective benefits (i.e. in carrying out the activities of daily living) of a computerized rehabilitation program addressing executive functions and based on virtual reality, simulating ADLs. We use in this study a multiple baseline single case experimental design (AB design with a follow-up beyond), including for each patient: pretreatment (phase A), treatment (phase B), and follow-up phase.

Pretreatment includes a routine sensitivomotor neurological rehabilitation program that doesn't specifically target executive functions in daily living activities (3 to 5 weeks depending on randomization). Treatment consists in a 4 weeks virtual reality cognitive training program, including four 45-minute sessions per week with an occupational therapist for cognitive rehabilitation in a virtual environment with the COVIRTUA Cognition software. The follow-up phase (5 to 3 weeks depending on randomization) includes no support for executive functions, either in a rehabilitation centre or in a liberal office.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Arm 1 (early phase B)

2 phases of cognitive training: Phase A : rehabilitation program in standard ergotherapy during 3 weeks Phase B : cognitive training using Covirtua Cognition software during 4 weeks

These 2 phases will be followed by a follow-up phase during 5 weeks

Group Type: EXPERIMENTAL

Covirtua Cognition software

Intervention Type: DEVICE

Cognitive training with Covirtua Cognition software

Arm 2 (mid phase B)

2 phases of cognitive training: Phase A : rehabilitation program in standard ergotherapy during 4 weeks Phase B : cognitive training using Covirtua Cognition software during 4 weeks

These 2 phases will be followed by a follow-up phase during 4 weeks

Group Type: EXPERIMENTAL

Covirtua Cognition software

Intervention Type: DEVICE

Cognitive training with Covirtua Cognition software

Arm 3 (late phase B)

2 phases of cognitive training: Phase A : rehabilitation program in standard ergotherapy during 5 weeks Phase B : cognitive training using Covirtua Cognition software during 4 weeks

These 2 phases will be followed by a follow-up phase during 3 weeks

Group Type: EXPERIMENTAL

Covirtua Cognition software

Intervention Type: DEVICE

Cognitive training with Covirtua Cognition software

Interventions

Covirtua Cognition software

Cognitive training with Covirtua Cognition software

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Vascular brain injury (stroke), in chronic phase (6 months or more after stroke), responsible for dysexecutive syndrome authenticated by the GREFEX/GRECO battery (Executive Function Evaluation Reflection Group)
• Men and women over the age of 18
• Presence of a caregiver
• Social Security affiliation
• Signing free and informed consent following clear and detailed information
• Sufficient understanding of the French language to participate in the study

Exclusion Criteria

• Pregnant women (clinical examination)
• Alcohol and/or narcotics addiction
• Major hearing deficit
• Major visual deficit
• Neurological pathology other than stroke or psychiatric disorder
• Unstable epilepsy
• Patient undergoing rehabilitation at a liberal therapist targeting executive functions during study time
• Patient under safeguard of justice.
• Patient simultaneously participating in another research study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie CATELLA

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Centre de la Tour de Gassies

Bruges, , France

Site Status: RECRUITING

Hôpital Swynghedauw

Lille, , France

Site Status: RECRUITING

University hospital of Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Emilie CATELLA

Role: CONTACT

catella.e@chu-toulouse.fr

561322986

Claire LEBELY

Role: CONTACT

lebely.c@chu-toulouse.fr

Facility Contacts

Amandine CONSTANT-COOK

Role: primary

Etienne ALLART

Role: primary

Emilie CATELLA

Role: primary

catella.e@chu-toulouse.fr

Claire LEBELY

Role: backup

lebely.c@chu-toulouse.fr

Other Identifiers

RC31/19/0552

Identifier Type: -

Identifier Source: org_study_id