Clinical trial NCT03472625: The Incidence of Aphasia, Dysarthria and Dysphagia Following Stroke
Official title: The Incidence, Severity and Recovery of Aphasia, Dysarthria and Dysphagia Following Stroke in a Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Stroke
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 557
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients recruited at the Acute Stroke Unit (university hospital Ghent)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Previous aphasia, dysarthria, dysphagia

Primary outcomes:
measure: Incidence of aphasia
timeFrame: 3 days
Secondary outcomes:
measure: Incidence of dysarthria
timeFrame: 3 days
measure: Incidence of dysphagia
timeFrame: 3 days
measure: Severity of aphasia (screening test)
timeFrame: 3 days
measure: Severity of aphasia (naming test)
timeFrame: 3 days
measure: severity of dysarthria (perceptual assessment)
timeFrame: 3 days
measure: severity of dysarthria (comprehensibility test)
timeFrame: 3 days
measure: severity of dysphagia (swallowing test)
timeFrame: 3 days
measure: severity of dysphagia (oral intake)
timeFrame: 3 days
measure: recovery of aphasia
timeFrame: 1 week, 3 months
measure: recovery of dysarthria
timeFrame: 1 week, 3 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital, department of neurology
state: East-Flanders
Study officials:
affiliation: University Ghent
name: veerle De Herdt
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Cock E, Batens K, Hemelsoet D, Boon P, Oostra K, De Herdt V. Dysphagia, dysarthria and aphasia following a first acute ischaemic stroke: incidence and associated factors. Eur J Neurol. 2020 Oct;27(10):2014-2021. doi: 10.1111/ene.14385. Epub 2020 Jun 30.