Clinical Trials Directory

Trials / Completed

CompletedNCT03472625

The Incidence of Aphasia, Dysarthria and Dysphagia Following Stroke

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

Status
Completed
Phase
Study type
Observational
Enrollment
557 (actual)
Sponsor
University Hospital, Ghent · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTScreening and diagnosis of aphasia, dysarthria, dysphagiaScreening (day 2 +/- 1; day 7 +/-1): NIHSS (National Health Institute Scale) 9 and 10 scores, dysphagia screening (nurse), speech-, and language screening (speech therapist) Diagnostic assessment (day 2 +/-1-): Dysphagia: MASA (Mann Assessment of Swallowing Abilities), FOIS (Functional Oral Intake Scale) Dysarthria: perceptual assessment, NSVO-Z (Nederlands spraakverstaanbaarheidsonderzoek - zinnen) Aphasia: ScreeLing, BNT (Boston Naming Test)

Timeline

Start date
2018-03-14
Primary completion
2019-10-04
Completion
2019-10-04
First posted
2018-03-21
Last updated
2024-09-19

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03472625. Inclusion in this directory is not an endorsement.