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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Covirtua Cognition software
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring N-of-1 trials, cognitive rehabilitation, computerized rehabilitation, virtual reality, executive functions, occupational therapy, post-stroke rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de la Tour de GassiesRecruiting
  • Hôpital SwynghedauwRecruiting
  • University hospital of ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1 (early phase B)

Arm 2 (mid phase B)

Arm 3 (late phase B)

Arm 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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 20, 2021
Last Updated
September 6, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT04855903
Brief Title
Executive Functions Computerized Rehabilitation Using Virtual Reality to Improve Activities of Daily Living Post-stroke
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
N-of-1 trials, cognitive rehabilitation, computerized rehabilitation, virtual reality, executive functions, occupational therapy, post-stroke rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multiple Baseline case experimental design (N-of-1 trial)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (early phase B)
Arm Type
Experimental
Arm 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
Arm Title
Arm 2 (mid phase B)
Arm Type
Experimental
Arm 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
Arm Title
Arm 3 (late phase B)
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Covirtua Cognition software
Intervention Description
Cognitive training with Covirtua Cognition software
Primary Outcome Measure Information:
Title
Evolution of performance at GAS (Goal Attainment Scaling)
Description
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.
Time Frame
T3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie CATELLA
Phone
561322986
Email
catella.e@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Claire LEBELY
Email
lebely.c@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie CATELLA
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de la Tour de Gassies
City
Bruges
ZIP/Postal Code
33523
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amandine CONSTANT-COOK
First Name & Middle Initial & Last Name & Degree
Amandine CONSTANT-COOK
Facility Name
Hôpital Swynghedauw
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne ALLART
First Name & Middle Initial & Last Name & Degree
Etienne ALLART
Facility Name
University hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie CATELLA
Email
catella.e@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Claire LEBELY
Email
lebely.c@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Emilie CATELLA
First Name & Middle Initial & Last Name & Degree
Corentin BIDOU
First Name & Middle Initial & Last Name & Degree
Xavier DE BOISSEZON

12. IPD Sharing Statement

Plan to Share IPD
No

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

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