Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes (R-LAST)
Primary Purpose
Stroke
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Right Language screening test (R-LAST)
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke focused on measuring Right hemispheric Stroke, Crossed aphasia, Acute phase
Eligibility Criteria
Inclusion Criteria:
- patients must be the age of majority
- Patients with right hemispheric stroke in the acute phase (internal validation + inter-examiner validation) or stabilization phase (external validation) confirmed by MRI or CT when MRI contraindicated
- Patient with no "mirror" crossed aphasia detected by the LAST procedure (A or B): LAST> 14
- Patients who read the newsletter
- Affiliation to a social security scheme
Criteria Exclusion:
- Minor patients
- No French speakers
- Patients with a history of stroke
- Patients with dementia
- Patients with sensory impairment: deafness, blindness
- Patient not 100% right handed in the Edinburgh questionnaire
- Inability to answer the Edinburgh Laterality Questionnaire and absence of any person to fill in the questionnaire.
- Patient with a left-handed person in its family
- Illiterate patients
- Patient presenting a "mirror" crossed aphasia detected by LAST A or B (score tolerated: 14/15 with error accepted to the automatic speech)
- Inability to receive the information letter about the protocol and to read the newsletter
- Refusal of the patient
Sites / Locations
- CH Sud Francilien
- CH de Versailles
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acute and subacute phase of right stroke
Arm Description
The intervention will be the passation of Right Language Screening Test (R-LAST). Patients in acute phase of right hemispheric stroke will be used for the internal validation and the integrated reliability of the Right Language screening test. Patients in subacute phase of right hemispheric stroke will be used for the external validation of the Right Language screening test.
Outcomes
Primary Outcome Measures
Score at R-LAST
Internal validation: no item will present effect floor, ceiling or of redundancy.
Validation inter examiner: the score obtained to R-LAST is independent from the examiner.
External validation: the patients detected by gold standard as presenting a speech difficulty bound to a right hemispherical lesion will also be him by R-LAST (no forgery negatives), and that the patients not presenting speech difficulty during the signing of these standard gold will obtain the maximum score to R-LAST (no forgery positive).
Secondary Outcome Measures
Score at LAST A and B
Detect the patients presenting a right hemispherical AVC with crossed aphasia "mirror"
Time of signing R-LAST
To obtain an average time of signing which will have to be shorter than that of the standard gold used during the external validation.
Simplicity and convenience of R-LAST
Contains only a sheet printed in black and white and both sides (to avoid the semantic indications bound to the color of an item, and to simplify the reproduction).
Visual aspect of R-LAST
Presentation in "portrait" mode, so that patients presenting a neurovisual disorder of type héminégligence or héminanopsie controlatérale are not penalized
Full Information
NCT ID
NCT03622606
First Posted
July 2, 2018
Last Updated
October 12, 2023
Sponsor
Versailles Hospital
Collaborators
Centre Hospitalier Sud Francilien
1. Study Identification
Unique Protocol Identification Number
NCT03622606
Brief Title
Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes
Acronym
R-LAST
Official Title
Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 25, 2018 (Actual)
Primary Completion Date
June 8, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital
Collaborators
Centre Hospitalier Sud Francilien
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 is a bi-centric study whose main objective is the validation of a rapid screening test for language disorders in the acute phase of right hemisphere stroke.
Primary objective
The main objective is the validation of a rapid language disorder screening tool that will be used in the acute phase of right hemispheric stroke.
Secondary objectives
Secondary objectives are:
Characterize the "atypical crossed aphasia" since the acute phase of stroke with a large cohort of patients , which, to our knowledge, has never been done.
Re-evaluate the number of patients with acute language disorder in right hemisphere stroke.
Validate the use of R-LAST by different categories of carers
Detailed Description
The R-LAST (Right Language screening test) comprises 8 subtests and a total of 15 items.
Validation will focus on the internal validity (no ceiling or floor effect, no redundancy, internal consistency), the external validity (against a "gold standard" in order to evaluate its specificity and its sensitivity) and the interclass agreement of R-LAST. The median time to administrate de scale will be calculated.
The investigators will validate the scale by administering it to 300 consecutive patients within 24 hours after admission to our 2 stroke units (Centre Hospitalier de Versailles and Centre hospitalier du sud francilien) and to 100 stabilized patients with and without atypical crossed aphasia using the MEC-P evaluation as a reference.
Patients must be 100% right-handed (Edinburgh test), be of French mother tongue, have no history of neurological disease, have no sensory disturbances (blindness, deafness) and no mirror crossed aphasia detected by the LAST (minimum score of 14/15 with a loss point granted for the "automatic speech" subtest, potentially stranded in right strokes)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Right hemispheric Stroke, Crossed aphasia, Acute phase
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acute and subacute phase of right stroke
Arm Type
Experimental
Arm Description
The intervention will be the passation of Right Language Screening Test (R-LAST).
Patients in acute phase of right hemispheric stroke will be used for the internal validation and the integrated reliability of the Right Language screening test.
Patients in subacute phase of right hemispheric stroke will be used for the external validation of the Right Language screening test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Right Language screening test (R-LAST)
Intervention Description
Validation of the Right Language screening test in acute and subacute phase of right stroke
Primary Outcome Measure Information:
Title
Score at R-LAST
Description
Internal validation: no item will present effect floor, ceiling or of redundancy.
Validation inter examiner: the score obtained to R-LAST is independent from the examiner.
External validation: the patients detected by gold standard as presenting a speech difficulty bound to a right hemispherical lesion will also be him by R-LAST (no forgery negatives), and that the patients not presenting speech difficulty during the signing of these standard gold will obtain the maximum score to R-LAST (no forgery positive).
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Score at LAST A and B
Description
Detect the patients presenting a right hemispherical AVC with crossed aphasia "mirror"
Time Frame
Day 1
Title
Time of signing R-LAST
Description
To obtain an average time of signing which will have to be shorter than that of the standard gold used during the external validation.
Time Frame
Day 1
Title
Simplicity and convenience of R-LAST
Description
Contains only a sheet printed in black and white and both sides (to avoid the semantic indications bound to the color of an item, and to simplify the reproduction).
Time Frame
Day 1
Title
Visual aspect of R-LAST
Description
Presentation in "portrait" mode, so that patients presenting a neurovisual disorder of type héminégligence or héminanopsie controlatérale are not penalized
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients must be the age of majority
Patients with right hemispheric stroke in the acute phase (internal validation + inter-examiner validation) or stabilization phase (external validation) confirmed by MRI or CT when MRI contraindicated
Patient with no "mirror" crossed aphasia detected by the LAST procedure (A or B): LAST> 14
Patients who read the newsletter
Affiliation to a social security scheme
Criteria Exclusion:
Minor patients
No French speakers
Patients with a history of stroke
Patients with dementia
Patients with sensory impairment: deafness, blindness
Patient not 100% right handed in the Edinburgh questionnaire
Inability to answer the Edinburgh Laterality Questionnaire and absence of any person to fill in the questionnaire.
Patient with a left-handed person in its family
Illiterate patients
Patient presenting a "mirror" crossed aphasia detected by LAST A or B (score tolerated: 14/15 with error accepted to the automatic speech)
Inability to receive the information letter about the protocol and to read the newsletter
Refusal of the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier SMADJA, Neurologist
Organizational Affiliation
Sud Francilien Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
CH de Versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes
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