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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rehabilitation of Executive Functions in the Activities of the Daily Living of Chronic Post-stroke Patients: Using Virtual Reality and Computerized Rehabilitation to Simulate Real Environment for Rehabilitation.

Conditions
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Stroke

Intervention / Treatment
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* Device: Covirtua Cognition software


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multiple Baseline case experimental design (N-of-1 trial)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 (early phase B)<br>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 | Device: Covirtua Cognition software<br>* Cognitive training with Covirtua Cognition software<br>|
| Experimental: Arm 2 (mid phase B)<br>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 | Device: Covirtua Cognition software<br>* Cognitive training with Covirtua Cognition software<br>|
| Experimental: Arm 3 (late phase B)<br>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 | Device: Covirtua Cognition software<br>* Cognitive training with Covirtua Cognition software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of performance at GAS (Goal Attainment Scaling) | Performance in carrying out activities of daily living will be evaluated in an ecological situation using Kiresuk and Sherman's 'Goal Attainment Scaling' (GAS) method. The individual goals to be achieved and performance levels of the GAS will be determined at inclusion, and evaluated twice a week during the three phases (A, B and follow-up phase). The primary outcome will be the evolution of the GAS score evaluated twice a week during 3 months. | T3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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N-of-1 trials, cognitive rehabilitation, computerized rehabilitation, virtual reality, executive functions, occupational therapy, post-stroke rehabilitation