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Completed

NCT Number: NCT03472625

The Incidence of Aphasia, Dysarthria and Dysphagia Following Stroke

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, department of neurology

Ghent, East-Flanders, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous aphasia, dysarthria, dysphagia

Treatment and study plan

Screening and diagnosis of aphasia, dysarthria, dysphagia

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)

Primary outcomes

  1. Incidence of aphasia

    Time frame: 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)

Secondary outcomes

  1. Incidence of dysarthria

    Time frame: 3 days

    based on the National Institute for Health Stroke Scale (NIHSS), subscale 10. This subscale measures whether a patient has dysarthria and if yes, to what degree. Scores range from 0 (= normal) to 2 (= severe dysarthria).

  2. Incidence of dysphagia

    Time frame: 3 days

    based on a nurse screening

  3. Severity of aphasia (screening test)

    Time frame: 3 days

    The severity of aphasia is determined based on a linguistic screening (ScreeLing) performed by a speech pathologist (scores on phonology, semantics, syntaxis)

  4. Severity of aphasia (naming test)

    Time frame: 3 days

    The severity of aphasia is determined based on a naming test (BNT) performed by a speech pathologist

  5. severity of dysarthria (perceptual assessment)

    Time frame: 3 days

    The severity of dysarthria is based on a perceptual assessment performed by the speech pathologist (qualitative assessment)

  6. severity of dysarthria (comprehensibility test)

    Time frame: 3 days

    severity of dysarthria is based on a comprehensibility test (NSVO-Z) performed by a speech pathologist (ranging from 0% to 100% comprehensibility)

  7. severity of dysphagia (swallowing test)

    Time frame: 3 days

    severity of dysphagia is based on a swallowing test (MASA) performed by a speech pathologist

  8. severity of dysphagia (oral intake)

    Time frame: 3 days

    the severity of dysphagia is based on an oral intake scale (FOIS) ranging from 0 (no oral intake) to 7 (normal orale intake)

  9. recovery of aphasia

    Time frame: 1 week, 3 months

    recovery of aphasia is based on the NIHSS 9 at 1 week and 3 months

  10. recovery of dysarthria

    Time frame: 1 week, 3 months

    recovery of dysarthria is based on the NIHSS 10 at 1 week and 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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