The Incidence of Aphasia, Dysarthria and Dysphagia Following Stroke

NCT ID: NCT03472625

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

557 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-14

Study Completion Date

2019-10-04

Brief Summary

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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

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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

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Acute Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute stroke patients

All acute stroke patients will be screened for aphasia, dysarthria or dysphagia. When one of the symptoms is present, standardized assessments will follow to evaluate the severity. Recovery in time will be measured +/- 1 week following stroke.

Screening and diagnosis of aphasia, dysarthria, dysphagia

Intervention Type DIAGNOSTIC_TEST

Screening (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)

Interventions

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Screening and diagnosis of aphasia, dysarthria, dysphagia

Screening (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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous aphasia, dysarthria, dysphagia
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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veerle De Herdt

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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University Hospital, department of neurology

Ghent, East-Flanders, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 32515514 (View on PubMed)

Other Identifiers

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B670201835160

Identifier Type: -

Identifier Source: org_study_id

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