NCT03472625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
557

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

March 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2019

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

March 5, 2018

Last Update Submit

September 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Incidence of dysarthria

    3 days

  • Incidence of dysphagia

    3 days

  • Severity of aphasia (screening test)

    3 days

  • Severity of aphasia (naming test)

    3 days

  • severity of dysarthria (perceptual assessment)

    3 days

  • +5 more secondary outcomes

Study Arms (1)

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.

Diagnostic Test: Screening and diagnosis of aphasia, dysarthria, dysphagia

Interventions

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)

Acute stroke patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients recruited at the Acute Stroke Unit (university hospital Ghent)

You may qualify if:

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

You may not qualify if:

  • Previous aphasia, dysarthria, dysphagia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, department of neurology

Ghent, East-Flanders, 9000, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • veerle De Herdt

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 21, 2018

Study Start

March 14, 2018

Primary Completion

October 4, 2019

Study Completion

October 4, 2019

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations