Acute StrokeNCT03472625
The Incidence of Aphasia, Dysarthria and Dysphagia Following Stroke
An observational study of Acute Stroke, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Screening and diagnosis of aphasia, dysarthria, dysphagia
- Type of treatment
- Pill or oral medicine
- How many people
- 557 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Mar 2018to 4 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients recruited at the Acute Stroke Unit (university hospital Ghent)
Who may be able to join
- Acute stroke patients admitted at the Acute Stroke Unit at the university hospital (Ghent)
Who cannot join
- Previous aphasia, dysarthria, dysphagia
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospital, department of neurology
Ghent, East-Flanders, 9000
About this study
Official title: The Incidence, Severity and Recovery of Aphasia, Dysarthria and Dysphagia Following Stroke in a Tertiary Hospital
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.
Read the 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
- Acute Stroke
- Being tested
- Screening and diagnosis of aphasia, dysarthria, dysphagia
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and diagnosis of aphasia, dysarthria, dysphagiaDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Screening and diagnosis of aphasia, dysarthria, dysphagia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 days
Secondary outcomes (10)
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).
Measured: 3 days
Incidence of dysphagia
based on a nurse screening
Measured: 3 days
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)
Measured: 3 days
Severity of aphasia (naming test)
The severity of aphasia is determined based on a naming test (BNT) performed by a speech pathologist
Measured: 3 days
severity of dysarthria (perceptual assessment)
The severity of dysarthria is based on a perceptual assessment performed by the speech pathologist (qualitative assessment)
Measured: 3 days
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)
Measured: 3 days
severity of dysphagia (swallowing test)
severity of dysphagia is based on a swallowing test (MASA) performed by a speech pathologist
Measured: 3 days
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)
Measured: 3 days
recovery of aphasia
recovery of aphasia is based on the NIHSS 9 at 1 week and 3 months
Measured: 1 week, 3 months
recovery of dysarthria
recovery of dysarthria is based on the NIHSS 10 at 1 week and 3 months
Measured: 1 week, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start14 Mar 2018
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- veerle De Herdt, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472625
- Sponsor's protocol ID
- B670201835160
- Status last verified
- Sep 2024
- First submitted
- 5 Mar 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32515514
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence, Severity and Recovery of Aphasia, Dysarthria and Dysphagia Following Stroke in a Tertiary Hospital
- ClinicalTrials.gov ID
- NCT03472625
- Acronym / sponsor ID
- B670201835160
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute stroke patients | – | Diagnostic Test: Screening and diagnosis of aphasia, dysarthria, dysphagiaAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients recruited at the Acute Stroke Unit (university hospital Ghent)
Key inclusion criteria (1 listed)
- Acute stroke patients admitted at the Acute Stroke Unit at the university hospital (Ghent)
Key exclusion criteria (1 listed)
- Previous aphasia, dysarthria, dysphagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening 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) | Diagnostic test | Acute stroke patients |
Primary outcome
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)
10 secondary outcomes
Incidence of dysarthria
Time frame: 3 days
Incidence of dysphagia
Time frame: 3 days
Severity of aphasia (screening test)
Time frame: 3 days
Severity of aphasia (naming test)
Time frame: 3 days
severity of dysarthria (perceptual assessment)
Time frame: 3 days
severity of dysarthria (comprehensibility test)
Time frame: 3 days
severity of dysphagia (swallowing test)
Time frame: 3 days
severity of dysphagia (oral intake)
Time frame: 3 days
recovery of aphasia
Time frame: 1 week, 3 months
recovery of dysarthria
Time frame: 1 week, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 32515514De 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
veerle De Herdt principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of aphasia (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03472625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.