CClinicalTrials.gg
TerminatedNCT04282564FéCO-OPSAUpdated Jun 6, 2022

Improvement of Executive Functions With the CO-OP Method in the Adult Subject After Stroke

An interventional study of Co-OP treatment in Cerebrovascular Accident, sponsored by University Hospital, Toulouse. Terminated at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-06-06.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment

Why this study was terminated
COVID lockdown + financial problems + no inclusion since lockdown
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The research focuses on top-down intervention approaches and more specifically on the Cognitive Orientation to daily Occupational Performance (CO-OP) method in the rehabilitation of executive function disorders in adult post-stroke subjects in chronic phase. The main objective of this study is therefore to improve performance in significant activities of daily living for people with chronic post-stroke dysexecutive disorders.

Read the detailed description

Today, approaches to intervention with adults after stroke can be categorized into two groups: bottom-up approaches (neurodevelopmental, sensory integration, mental imagery, cognitive stimulation, perceptual-motor/kinesthetic training...) and top-down approaches (task-oriented approach, neuromotor task training, occupational performance coaching, the CO-OP approach). Although bottom-up intervention approaches have existed for several years longer than top-down approaches, in general, top-down intervention approaches have shown better results.

In the latest work with post-stroke adults with objective cognitive impairment, the data indicate the relevance of CO-OP in improving performance and satisfaction, attention, inhibition and flexibility or apathy.

This study aims to demonstrate the effectiveness of the CO-OP approach in adult post-stroke patients in chronic phase, specifically on planning function, through the Single Case Experimental Design methodology by randomized intervention (3 patients) over 6 weeks of treatment and 10 weeks of evaluation.

02

Conditions studied

  • Cerebrovascular Accident

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Keywords

  • CO-OP
  • executive functions
  • stroke
  • single-case experimental designs
  • transfer of knowledge
  • sens of self efficacy
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 3 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Stroke responsible for a dysexecutive syndrome authenticated by the GREFEX battery
  • Stroke more than 6 months old (chronic phase)
  • Social security affiliation
  • Signing of a free and informed consent following clear and detailed information.

Exclusion criteria

Exclusion Criteria:

  • Disorder of comprehension objectified by the - LAnguage Screening Test (LAST) (minimum score 4/8 in expression and 6/7 in comprehension)
  • Significant anosognosia of dysexecutive syndrome
  • Pregnant women
  • Neurological condition other than stroke or psychiatric disorder
  • Patient following a rehabilitation with a liberal therapist targeting executive functions during the period of participation in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    CO-OP Arm (early phase A)

    Patients will be integrated during the traditional day hospitalization follow-up, at the rate of 3 sessions per week. The patient will have 2 phases : phase A: CO-OP treatment during 6 week and phase B : without specific treatment during 3 weeks.

    Other: Co-OP treatment

  • Experimental
    CO-OP Arm (mid phase A)

    Patients will be integrated during the traditional day hospitalization follow-up, at the rate of 3 sessions per week. The patient will have 2 phases : phase A: CO-OP treatment during 6 week and phase B : without specific treatment during 2.5 weeks.

    Other: Co-OP treatment

  • Experimental
    CO-OP Arm (late phase A)

    Patients will be integrated during the traditional day hospitalization follow-up, at the rate of 3 sessions per week. The patient will have 2 phases : phase A: CO-OP treatment during 6 week and phase B : without specific treatment during 2 weeks.

    Other: Co-OP treatment

Interventions

  • OtherCo-OP treatment

    The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is described as "a patient-centred, performance-oriented approach to activities and problem solving that allows skills to be acquired through a process of strategy use and guided discovery". The CO-OP protocol is composed of seven key characteristics: i) the goals chosen by the patient, ii) dynamic performance analysis, iii) the use of cognitive strategies, iv) guided discovery, v) the principles of empowerment, vi) the involvement of a relative, vii) the structure of the intervention (Polatajko and Mandich, 2004/2017). CO-OP is an evidence-based approach to intervention, including evidence of its effectiveness on a physical, cognitive and emotional dimension in adults with stroke

06

What researchers measure

Primary outcomes

  1. Improved performance in significant activities of daily living

    Improved performance in significant activities of daily living will be measured bi-weekly by the Canadian Occupational Performance Measurement. The score is between 1 to 10

    Time frame: 10 weeks

  2. Improved performance in significant activities of daily living

    Improved performance in significant activities of daily living will be measured bi-weekly by the Performance Quality Rating Scale. The score is between 1 to 10

    Time frame: 10 weeks

Secondary outcomes

  1. improvement in the sense of personal effectiveness

    The improvement in the sense of personal effectiveness will be measured by New General Self-Efficacy Scale (8 questions with response to 1 for strongly disagree to 5 for strongly agree)

    Time frame: 10 weeks

  2. Analytically measure of executive functions

    The analytical improvement of executive functions will be measured by the Trail Making Tes

    Time frame: 10 weeks

  3. Analytically measure of executive functions

    The analytical improvement of executive functions will be measured by the number span (WAIS IV)

    Time frame: 10 weeks

  4. Analytically measure of executive functions

    The analytical improvement of executive functions will be measured by the Stroop test

    Time frame: 10 weeks

  5. Analytically measure of executive functions

    The analytical improvement of executive functions will be measured by the test "the Tower of London"

    Time frame: 10 weeks

  6. Analytically measure of executive functions

    The analytical improvement of executive functions will be measured by the Wisconsin Card Sorting test

    Time frame: 10 weeks

07

Study locations

1 site
  • University Hospital of Toulouse
    Toulouse, 31000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04282564
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Feb 24, 2020
Start date
Feb 24, 2020
Primary completion
Mar 29, 2022
Completion
Mar 29, 2022
Last update
Jun 6, 2022

Study contacts

Xavier De Boissezon, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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