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Clinical Trials/NCT03622606
NCT03622606
Active, not recruiting
Not Applicable

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

Versailles Hospital2 sites in 1 country400 target enrollmentSeptember 25, 2018
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Versailles Hospital
Enrollment
400
Locations
2
Primary Endpoint
Score at R-LAST
Status
Active, not recruiting
Last Updated
last year

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)

Registry
clinicaltrials.gov
Start Date
September 25, 2018
End Date
October 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Versailles Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Constance FLAMAND-ROZE

Neurosciences doctor

Versailles Hospital

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Score at R-LAST

Time Frame: Day 1

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 Outcomes

  • Visual aspect of R-LAST(Day 1)
  • Time of signing R-LAST(Day 1)
  • Score at LAST A and B(Day 1)
  • Simplicity and convenience of R-LAST(Day 1)

Study Sites (2)

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