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Cognitive Assessment for Stroke Patients: Reproductibility and Validity Study (Casper)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive Assessment test
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

For CVA patients

  • patients hospitalised in rehabilitation after a first recent hemispheric CVA (less than 6 weeks) ;
  • aged > 18;
  • absence of severe disorders of oral comprehension (BDAE aphasia severity score >2 for comprehension);
  • whatever the severity of oral expression disorders;
  • who have been given clear written and oral information, and after the doctor has verified their ability to understand the protocol.

For " Control " patients (to evaluate divergent validity)

  • patients hospitalised in rehabilitation units or geriatrics taking part in this study;
  • aged > 18.

Exclusion Criteria:

For CVA patients

  • patients who do not speak French;
  • cognitive disorders known before the CVA;
  • psychotic disorders known before the CVA;
  • major visual disorders incompatible with reading, known before the CVA.

For " Control " patients (to evaluate divergent validity)

  • patients who do not speak French;
  • cognitive disorders known before the CVA;
  • psychotic disorders known before the CVA;
  • major visual disorders incompatible with reading, known before the CVA.

Sites / Locations

  • CHU de Dijon

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cognitive Assessment

Arm Description

Outcomes

Primary Outcome Measures

comprehensive assessment battery of higher functions
comprehensive assessment battery of higher functions
comprehensive assessment battery of higher functions
test of visual memory
test of visual memory
test of visual memory

Secondary Outcome Measures

Full Information

First Posted
July 12, 2013
Last Updated
July 12, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01904799
Brief Title
Cognitive Assessment for Stroke Patients: Reproductibility and Validity Study
Acronym
Casper
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2015 (Actual)
Primary Completion Date
March 29, 2019 (Actual)
Study Completion Date
March 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
After a CVA, all of the cognitive functions can be affected and analysed, but the presence of a language disorder may considerably hamper the evaluation of other functions. The battery of rapid tests to screen for and quantify cognitive disorders, including the MMSE, the MOCA, the R-CAMCOG or the RBANS, are not suitable for aphasic patients because they contain items with a strictly verbal response. Because of this, inexperienced doctors cannot evaluate higher functions (other than language) of aphasics in routine practice. For the same reason, aphasics are regularly excluded from post-cva therapeutic protocols, whether or not the trial bears on the evolution of cognitive functions. Nonetheless, it is possible to evaluate, at least roughly, all of the cognitive functions without resorting to language. The investigator have developed , from validated tests and classical clinical manoeuvers, the Cognitive Assessment for Stroke Patients (CASP) : for the rapid screening (less than 15 minutes) and quantification of post-cva cognitive disorders (6 functions: language, apraxia, short-term memory, temporal orientation, impaired spatial/visio-construction and executive functions); the CASP can be used in most patients, including those with severe disorders of expression and moderate problems with comprehension, The format of these tests has been adapted so that severe disorders of expression (essentially left-hemisphere CVA), and left spatial impairment (right-hemisphere CVA) do not affect the ability to take the test. Its validity in terms of appearance and content were verified in 2011.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Assessment
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Cognitive Assessment test
Primary Outcome Measure Information:
Title
comprehensive assessment battery of higher functions
Time Frame
baseline
Title
comprehensive assessment battery of higher functions
Time Frame
Evaluation at 3 ±1 days
Title
comprehensive assessment battery of higher functions
Time Frame
Evaluation at 6 ± 2 weeks
Title
test of visual memory
Time Frame
baseline
Title
test of visual memory
Time Frame
Evaluation at 3 ±1 days
Title
test of visual memory
Time Frame
Evaluation at 6 ± 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For CVA patients patients hospitalised in rehabilitation after a first recent hemispheric CVA (less than 6 weeks) ; aged > 18; absence of severe disorders of oral comprehension (BDAE aphasia severity score >2 for comprehension); whatever the severity of oral expression disorders; who have been given clear written and oral information, and after the doctor has verified their ability to understand the protocol. For " Control " patients (to evaluate divergent validity) patients hospitalised in rehabilitation units or geriatrics taking part in this study; aged > 18. Exclusion Criteria: For CVA patients patients who do not speak French; cognitive disorders known before the CVA; psychotic disorders known before the CVA; major visual disorders incompatible with reading, known before the CVA. For " Control " patients (to evaluate divergent validity) patients who do not speak French; cognitive disorders known before the CVA; psychotic disorders known before the CVA; major visual disorders incompatible with reading, known before the CVA.
Facility Information:
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

Learn more about this trial

Cognitive Assessment for Stroke Patients: Reproductibility and Validity Study

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