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

Stroke Clinical Trial

— RéFEx  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04855903
• Other study ID #: RC31/19/0552
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2021
• Est. completion date: April 2025

Study information

• Verified date: September 2023
• Source: University Hospital, Toulouse
• Contact: Emilie CATELLA
• Phone: 561322986
• Email: catella.e[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Covirtua Cognition software
Cognitive training with Covirtua Cognition software

Locations

Country	Name	City	State
France	Centre de la Tour de Gassies	Bruges
France	Hôpital Swynghedauw	Lille
France	University hospital of Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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