Clinical trial NCT04855903: Executive Functions Computerized Rehabilitation Using Virtual Reality to Improve Activities of Daily Living Post-stroke
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: N-of-1 trials
cognitive rehabilitation
computerized rehabilitation
virtual reality
executive functions
occupational therapy
post-stroke rehabilitation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2021-04-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple Baseline case experimental design (N-of-1 trial)
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Evolution of performance at GAS (Goal Attainment Scaling)
timeFrame: T3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bruges
country: France
facility: Centre de la Tour de Gassies
city: Lille
country: France
facility: Hôpital Swynghedauw
city: Toulouse
country: France
facility: University hospital of Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Emilie CATELLA
role: PRINCIPAL_INVESTIGATOR
References: