Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Score at R-LAST
研究概览
简要总结
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
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Score at R-LAST
时间窗: 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).
次要结局
- 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)
研究者
Dr Constance FLAMAND-ROZE
Neurosciences doctor
Versailles Hospital