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

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Device: Covirtua Cognition software

• Registration Number: NCT04855903
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-22
• Study Start: 2021-09-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 (early phase B)	Covirtua Cognition software	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
Arm 3 (late phase B)	Covirtua Cognition software	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
Arm 2 (mid phase B)	Covirtua Cognition software	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

Primary Outcome Measures

Name	Time	Method
Evolution of performance at GAS (Goal Attainment Scaling)	T3 months	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.

Trial Locations

Locations (3)

Centre de la Tour de Gassies; 🇫🇷 Bruges, France

Hôpital Swynghedauw; 🇫🇷 Lille, France

University hospital of Toulouse; 🇫🇷 Toulouse, France