NCT04855903

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 21, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

3.5 years

First QC Date

April 20, 2021

Last Update Submit

September 6, 2023

Conditions

Stroke

Keywords

N-of-1 trialscognitive rehabilitationcomputerized rehabilitationvirtual realityexecutive functionsoccupational therapypost-stroke rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Arm 1 (early phase B)

EXPERIMENTAL

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

Arm 2 (mid phase B)

EXPERIMENTAL

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

Arm 3 (late phase B)

EXPERIMENTAL

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

Interventions

Covirtua Cognition softwareDEVICE

Cognitive training with Covirtua Cognition software

Arm 1 (early phase B)Arm 2 (mid phase B)Arm 3 (late phase B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre de la Tour de Gassies

Bruges, 33523, France

RECRUITING

Hôpital Swynghedauw

Lille, France

RECRUITING

University hospital of Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Emilie CATELLA

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie CATELLA

CONTACT

561322986catella.e@chu-toulouse.fr

Claire LEBELY

CONTACT

lebely.c@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Multiple Baseline case experimental design (N-of-1 trial)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 22, 2021

Study Start

September 21, 2021

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)