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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03622606
Acronym
R-LAST
Enrollment
400
Registered
2018-08-09
Start date
2018-09-25
Completion date
2024-10-31
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Right hemispheric Stroke, Crossed aphasia, Acute phase

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)

Interventions

DIAGNOSTIC_TESTRight Language screening test (R-LAST)

Validation of the Right Language screening test in acute and subacute phase of right stroke

Sponsors

Centre Hospitalier Sud Francilien
CollaboratorOTHER
Versailles Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Score at R-LASTDay 1Internal 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

MeasureTime frameDescription
Score at LAST A and BDay 1Detect the patients presenting a right hemispherical AVC with crossed aphasia mirror
Time of signing R-LASTDay 1To 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-LASTDay 1Contains 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-LASTDay 1Presentation in portrait mode, so that patients presenting a neurovisual disorder of type héminégligence or héminanopsie controlatérale are not penalized

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026