- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00141752
Toronto Bedside Swallowing Screening Test (TOR-BSST) - A Bedside Swallowing Screening for Stroke Patients
October 31, 2016 updated by: University Health Network, Toronto
This research will assess the accuracy of the Toronto Bedside Swallowing Screening Test (TOR-BSST), a new dysphagia screening test for patients with stroke.
The purpose of the TOR-BSST is to predict the presence of dysphagia in stroke patients across their continuum of care in a simple and efficient manner.
This initial research will assess the accuracy of the TOR-BSST in the acute and rehabilitative settings using videofluoroscopy as the gold standard for comparison.
The results from this research will also assess the stability of the TOR-BSST across nursing, its primary user, and generate an estimate for the prevalence of dysphagia in adult stroke patients in the acute and rehabilitative settings.
Participants in this research will be 315 stroke patients from several teaching centres in Ontario, namely 105 acute patients from the University Health Network, Sunnybrook & Women's College Health Sciences Centre, and Hamilton General Hospital, and 210 patients in the rehabilitation setting from the Toronto Rehabilitation Institute and Parkwood Hospital, London.
Both the TOR-BSST and videofluoroscopic assessment will be administered within 24 hours of each other and interpreted according to published preferred practice guidelines for dysphagia.
This research will be the first to implement and assess a standardised method for screening for dysphagia in stroke patients across the continuum of stroke recovery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
311
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
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London, Ontario, Canada, N6C 5J1
- Parkwood Hospital
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Toronto, Ontario, Canada, M5G 2A2
- Toronto Rehabilitation Institute
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital, University Health Network
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook and Women's College Health Sciences Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Newly admitted patients with a diagnosis of stroke (refer to eligibility criteria)
Description
Inclusion Criteria:
- patients with a new diagnosis of brainstem or cerebellar stroke
- patients with a new diagnosis of cortical stroke with NIH Stroke Scale score of 4 or above
Exclusion Criteria:
- patients with a previous history of stroke with dysphagia
- patients with a confirmed history of Parkinson's, Parkinsonian Syndrome, ALS, MSA, MS, dementia, or other neurodegenerative disease
- patients with a history of cranial neurosurgery
- patients with a known previous or current oropharyngeal dysphagia due to structural or neurological cause
- patients with active COPD or current pneumonia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Rosemary Martino, PhD, University of Toronto
- Principal Investigator: Nicholas E Diamant, MD, University Health Network, Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
- Martino R, Pron G, Diamant N. Screening for oropharyngeal dysphagia in stroke: insufficient evidence for guidelines. Dysphagia. 2000 Winter;15(1):19-30. doi: 10.1007/s004559910006.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Primary Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
August 30, 2005
First Submitted That Met QC Criteria
August 30, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Estimate)
November 1, 2016
Last Update Submitted That Met QC Criteria
October 31, 2016
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSN II.10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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