Stroke Clinical Trial
Official title:
Validity of a New Stroke Dysphagia Screening Tool
Dysphagia or swallowing difficulty is common after stroke occurring in 25-78% of stroke survivors depending on the anatomic location of the stroke and the diagnostic test used. There are no universally accepted methods for doing a screen test at the bedside in the immediate setting after stroke. This study will assess the reliability of a bedside screen in terms of reproducibility of results between 2 independent screeners and in comparison to a fiberoptic study done by a speech language pathologist.
Specific Aims:
1. To show that the dysphagia screening tool achieves greater than 90% positive and
negative predictive values relative to the gold standard for dysphagia defined in this
study as the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) as performed by
speech-language pathologists.
2. To show that the risk of aspiration pneumonia is less than 10% during hospitalization
in patients undergoing the dysphagia screening tool.
3. To show that the dysphagia screening tool is applicable across the spectrum of stroke
severity, as defined by the NIH stroke scale score.
4. To assess specific components and combinations of components of the dysphagia screening
tool with respect to positive and negative predictive values.
5. To show that the dysphagia screening tool has excellent inter-rater reliability and can
be performed in under 5 minutes.
Methods: The investigators will recruit 18 patients with a clinical diagnosis of acute
ischemic stroke. Patients with a clinical diagnosis of stroke will initially be screened
with the dysphagia screening tool within 24 hours of last known well admission by two
separate evaluators performed no more than 2 hours apart. The first evaluator will be either
a nurse (e.g. emergency medicine nurse) or physician (e.g. neurology resident) certified in
use of the screen. The second evaluator will be the nurse research coordinator for the
study. The first screen is part of routine clinical care and will be used to determine the
patient's eating status (NPO or full diet). Timing between evaluations will be recorded.
Patients will include those with an NIHSS of 8-16 inclusive. Patients with primary
intracerebral hemorrhage and those who are unable to read the consent form due to language
barrier (not aphasia) will be excluded from this study. Consent for aphasic patients will be
obtained from an authorized representative. Lesion side (right, left), lesion location
(hemispheric, brainstem, cerebellar), and TOAST classification (a validated method of stroke
mechanism classification) will be recorded. The results of patients who are initially
enrolled in the study but later excluded because of brain imaging findings will be recorded.
Patients who are studied by FEES within 6 hours of the first bedside screen by ASHA
certified speech-language pathologists will be included. Time from screening to FEES
examination will be recorded. A patient studied more than 6 hours after the first bedside
screen will be excluded. Patients who passed the initial screen but later failed FEES
examination will be made NPO because of the potential implications for clinical outcome.
Patients who fail the initial screen but who later pass the FEES examination wil be released
from NPO status. Results of brain imaging will also be recorded. Patients with negative
brain imaging will also be included because diagnostic imaging with CT may not be sensitive
in the first 24 hours and MRI may not be available within hours of arrival. Patients
included in the study will also be followed during their hospitalization for clinical
evidence of aspiration pneumonia up to 7 days. A 90-day phone call will be made to determine
the patient's level of function according to the modified Rankin scale, a standard outcome
tool for stroke. Patients whose final diagnosis is not stroke will be excluded from
analysis.
Statistical analysis:
Inter-rater reliability between bedside screeners will be calculated. Results of the screen
performed by the last bedside screener will be compared to findings on FEES. Sensitivity,
specificity, positive predictive value, and negative predictive value scores will be
calculated using 2 by 2 table analysis. Likelihood ratios will be calculated. Aspiration
pneumonia rates will be described with descriptive statistics.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|