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

September 6, 2023 updated by: University Hospital, Toulouse

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bruges, France, 33523
        • Recruiting
        • Centre de la Tour de Gassies
        • Contact:
          • Amandine CONSTANT-COOK
        • Principal Investigator:
          • Amandine CONSTANT-COOK
      • Lille, France
        • Recruiting
        • Hôpital Swynghedauw
        • Contact:
          • Etienne ALLART
        • Principal Investigator:
          • Etienne ALLART
      • Toulouse, France, 31059
        • Recruiting
        • University Hospital of Toulouse
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emilie CATELLA
        • Sub-Investigator:
          • Corentin BIDOU
        • Sub-Investigator:
          • Xavier DE BOISSEZON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (early phase B)

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
Cognitive training with Covirtua Cognition software
Experimental: Arm 2 (mid phase B)

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
Cognitive training with Covirtua Cognition software
Experimental: Arm 3 (late phase B)

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
Cognitive training with Covirtua Cognition software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of performance at GAS (Goal Attainment Scaling)
Time Frame: 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.
T3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Emilie CATELLA, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/19/0552

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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