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The Incidence of Aphasia, Dysarthria and Dysphagia Following Stroke

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ClinicalTrials.gov Identifier: NCT03472625
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Neurologie, University Hospital, Ghent

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.


Condition or disease Intervention/treatment
Acute Stroke Diagnostic Test: Screening and diagnosis of aphasia, dysarthria, dysphagia

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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Incidence, Severity and Recovery of Aphasia, Dysarthria and Dysphagia Following Stroke in a Tertiary Hospital
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : March 12, 2022
Estimated Study Completion Date : March 12, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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

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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients recruited at the Acute Stroke Unit (university hospital Ghent)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous aphasia, dysarthria, dysphagia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472625


Contacts
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Contact: veerle De Herdt 09/3326481 veerle.deherdt@ugent.be
Contact: Elien De Cock 0478/213784 evedcock.decock@hotmail.com

Locations
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Belgium
University Hospital, department of neurology Recruiting
Ghent, East-Flanders, Belgium, 9000
Contact: Veerle De Herdt    09/3326481    veerle.deherdt@ugent.be   
Contact: Elien De Cock    0478/213784    evedcock.decock@ugent.be   
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: veerle De Herdt University Ghent

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Responsible Party: Neurologie, Prof. Dr. De Herdt, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03472625     History of Changes
Other Study ID Numbers: B670201835160
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Aphasia
Dysarthria
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Articulation Disorders