Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes

Study Overview
=================
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)

Official Title
-----------------
Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Diagnostic Test: Right Language screening test (R-LAST)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute and subacute phase of right stroke<br>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. | Diagnostic Test: Right Language screening test (R-LAST)<br>* Validation of the Right Language screening test in acute and subacute phase of right stroke<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score at LAST A and B | Detect the patients presenting a right hemispherical AVC with crossed aphasia mirror | Day 1 | 
| 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. | Day 1 | 
| 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). | Day 1 | 
| 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 | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Right hemispheric Stroke, Crossed aphasia, Acute phase