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

NCT ID: NCT03622606

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-25
• Study Completion Date: 2024-10-31

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)

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Acute and subacute phase of right stroke

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.

Group Type: EXPERIMENTAL

Right Language screening test (R-LAST)

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Right Language screening test (R-LAST)

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Sud Francilien

OTHER

Sponsor Role: collaborator

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr Constance FLAMAND-ROZE

Neurosciences doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Didier SMADJA, Neurologist

Role: PRINCIPAL_INVESTIGATOR

Sud Francilien Hospital

Locations

CH Sud Francilien

Corbeil-Essonnes, , France

CH de Versailles

Le Chesnay, , France

Countries

France

Other Identifiers

P17/07_R-LAST

Identifier Type: -

Identifier Source: org_study_id