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临床试验/NCT03472625
NCT03472625已完成不适用

The Incidence, Severity and Recovery of Aphasia, Dysarthria and Dysphagia Following Stroke in a Tertiary Hospital

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 557 人开始时间: 2018年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
557
试验地点
1
主要终点
Incidence of aphasia

研究概览

简要总结

The objective of the study is to estimate the incidence and recovery of aphasia, dysarthria and dysphagia in an acute setting (first week) with the NIHSS sub-item scores for language and speech and a dysphagia screening.

Furthermore, we will evaluate the severity of aphasia, dysarthria and dysphagia in an acute setting (first few days) with standardized measurements (ScreeLing, BNT, NSVO-Z, perceptual assessment, MASA/FOIS).

To evaluate the effect of early IVT/EVT in patients with ischemic stroke on functional outcomes for language and speech via the NIHSS scale.

详细描述

Study population:

Patients who are admitted to the acute Stroke Unit of the University Hospital Ghent will be recruited.

Study course:

The study has a prospective, observational design, with each participant receiving regular standard of care as follows: patients will undergo a clinical examination by a staff neurologists or the present attending in the emergency room. Tailored medical treatment will be given to each patient considering the type of stroke etc. as is standard of care (e.g. thrombolysis and/or thrombectomy for patients with ischemic stroke). Patients that are stable enough are transferred to the Stroke Unit where the neurologist or attending of the unit will reassess all stroke patients. NIHSS scores will be reported at least at day 2 +/- 1. A dysphagia screening is performed by the Stroke Unit nurses when the patient arrives at the Stroke Unit. The scores of the sub-items language and speech of the NIHSS and the dysphagia screening combined with a general screening by a speech language pathologist will be used to confirm or discard aphasia, dysphagia and dysarthria (incidence). When aphasia, dysarthria and/or dysphagia is confirmed, standardized tests will be performed. For this study, data of the following tests will be included for analysis: ScreeLing and/or BNT (aphasia), NSVO-Z and a perceptual assessment (dysarthria), MASA and/or the FOIS (dysphagia). At day 7 +/- 1, NIHSS scores will be reassessed (recovery in time). The diagnostic assessments and the NIHSS sub-items speech/language will be used to investigate the severity and recovery of the symptoms in time. Reports of the neurological clinical examination at follow-up will be retrospectively investigated if possible for additional information about recovery in time.

The total duration of data collection will be approximately 1 week and if possible three months follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Acute stroke patients admitted at the Acute Stroke Unit at the university hospital (Ghent)

排除标准

  • Previous aphasia, dysarthria, dysphagia

结局指标

主要结局

Incidence of aphasia

时间窗: 3 days

Incidence is based on the National Institute for Health Stroke Scale (NIHSS), subscale 9. The NIHSS is used to quantify the impairment in patients after stroke. For the incidence of aphasia, subscale 9 of the NIHSS scale is used (best language). It investigates whether a patient has aphasia and what degree if present. Scores on this subscale range from 0 (= normal) to 3 (= mute/global aphasia)

次要结局

  • Incidence of dysarthria(3 days)
  • Incidence of dysphagia(3 days)
  • Severity of aphasia (screening test)(3 days)
  • Severity of aphasia (naming test)(3 days)
  • severity of dysarthria (perceptual assessment)(3 days)
  • severity of dysarthria (comprehensibility test)(3 days)
  • severity of dysphagia (oral intake)(3 days)
  • recovery of aphasia(1 week, 3 months)
  • recovery of dysarthria(1 week, 3 months)
  • severity of dysphagia (swallowing test)(3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neurologie

Prof. Dr. De Herdt

University Hospital, Ghent

研究点 (1)

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