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

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.

Sponsors

Lead Sponsor: University Hospital, Toulouse

Collaborator: Ministry of Health, France

Source University Hospital, Toulouse
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.

Overall Status Not yet recruiting
Start Date 2021-05-01
Completion Date 2023-03-01
Primary Completion Date 2023-03-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Evolution of performance at GAS (Goal Attainment Scaling) T3 months
Enrollment 27
Condition
Intervention

Intervention Type: Device

Intervention Name: Covirtua Cognition software

Description: Cognitive training with Covirtua Cognition software

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Emilie CATELLA Principal Investigator University Hospital, Toulouse
Overall Contact

Last Name: Emilie CATELLA

Phone: 561322986

Email: [email protected]

Location
Facility: Contact: Contact Backup: Investigator: University hospital of Toulouse Emilie CATELLA [email protected] Emilie CATELLA Principal Investigator Corentin BIDOU Sub-Investigator Xavier DE BOISSEZON Sub-Investigator
Location Countries

France

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Arm 1 (early phase B)

Type: Experimental

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

Label: Arm 2 (mid phase B)

Type: Experimental

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

Label: Arm 3 (late phase B)

Type: Experimental

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

Acronym RéFEx
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Multiple Baseline case experimental design (N-of-1 trial)

Primary Purpose: Other

Masking: Single (Outcomes Assessor)

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