The Incidence of Aphasia, Dysarthria and Dysphagia Following Stroke

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472625
• Other study ID #: B670201835160
• Status: Completed
• Start date: March 14, 2018
• Est. completion date: October 4, 2019

Study information

• Verified date: December 2019
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 557
• Est. completion date: October 4, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previous aphasia, dysarthria, dysphagia

Related Conditions & MeSH terms

• Acute Stroke
• Aphasia
• Dysarthria
• Stroke

Intervention

Diagnostic Test:
• 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)

Locations

Country	Name	City	State
Belgium	University Hospital, department of neurology	Ghent	East-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of aphasia	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)	3 days
Secondary	Incidence of dysarthria	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).	3 days
Secondary	Incidence of dysphagia	based on a nurse screening	3 days
Secondary	Severity of aphasia (screening test)	The severity of aphasia is determined based on a linguistic screening (ScreeLing) performed by a speech pathologist (scores on phonology, semantics, syntaxis)	3 days
Secondary	Severity of aphasia (naming test)	The severity of aphasia is determined based on a naming test (BNT) performed by a speech pathologist	3 days
Secondary	severity of dysarthria (perceptual assessment)	The severity of dysarthria is based on a perceptual assessment performed by the speech pathologist (qualitative assessment)	3 days
Secondary	severity of dysarthria (comprehensibility test)	severity of dysarthria is based on a comprehensibility test (NSVO-Z) performed by a speech pathologist (ranging from 0% to 100% comprehensibility)	3 days
Secondary	severity of dysphagia (swallowing test)	severity of dysphagia is based on a swallowing test (MASA) performed by a speech pathologist	3 days
Secondary	severity of dysphagia (oral intake)	the severity of dysphagia is based on an oral intake scale (FOIS) ranging from 0 (no oral intake) to 7 (normal orale intake)	3 days
Secondary	recovery of aphasia	recovery of aphasia is based on the NIHSS 9 at 1 week and 3 months	1 week, 3 months
Secondary	recovery of dysarthria	recovery of dysarthria is based on the NIHSS 10 at 1 week and 3 months	1 week, 3 months