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

Toulouse University Hospital

Status: Enrolling

Conditions: Stroke

Treatments: Device: Covirtua Cognition software

Study type: Interventional

Funder types: Other

Identifiers

NCT04855903

RC31/19/0552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 3 patient groups

Arm 1 (early phase B)

Experimental group

Description:

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

Treatment:

Device: Covirtua Cognition software

Arm 2 (mid phase B)

Experimental group

Description:

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

Treatment:

Device: Covirtua Cognition software

Arm 3 (late phase B)

Experimental group

Description:

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

Treatment:

Device: Covirtua Cognition software