Cerebrovascular AccidentNCT00141752
Toronto Bedside Swallowing Screening Test (TOR-BSST) - A Bedside Swallowing Screening for Stroke Patients
An observational study of Cerebrovascular Accident and Deglutition Disorders, run by University Health Network, Toronto at 5 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident, Deglutition Disorders
- What is being tested?
- Toronto Bedside Swallowing Screening Test (TOR-BSST)
- Type of treatment
- Medical device
- How many people
- 311 participants
- Where
- 5 sitesCanada
- Study dates
- Oct 2002to Dec 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly admitted patients with a diagnosis of stroke (refer to eligibility criteria)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Parkwood Hospital
London, Ontario, N6C 5J1
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5
Toronto Rehabilitation Institute
Toronto, Ontario, M5G 2A2
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
About this study
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.
- Conditions
- Cerebrovascular Accident, Deglutition Disorders
- Being tested
- Toronto Bedside Swallowing Screening Test (TOR-BSST)
- Keywords
- Cerebrovascular Accident, Deglutition Disorders, stroke, dysphagia, screening
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toronto Bedside Swallowing Screening Test (TOR-BSST)Device
Toronto Bedside Swallowing Screening Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Stroke Network, Toronto Rehabilitation Institute, Parkwood Hospital, London, Ontario, Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Rosemary Martino, PhD, Principal investigator, University of TorontoNicholas E Diamant, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141752
- Sponsor's protocol ID
- CSN II.10
- Status last verified
- Jan 2012
- First submitted
- 30 Aug 2005
- Last updated
- 1 Nov 2016
- Results posted
- No
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.
PubMed 16269630Martino 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.
PubMed 10594255
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toronto Bedside Swallowing Screening Test (TOR-BSST) - A Bedside Swallowing Screening for Stroke Patients
- ClinicalTrials.gov ID
- NCT00141752
- Acronym / sponsor ID
- CSN II.10
- Conditions
- Cerebrovascular Accident, Deglutition Disorders
- Keywords
- Cerebrovascular Accident, Deglutition Disorders, stroke, dysphagia, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Stroke Network, Toronto Rehabilitation Institute, Parkwood Hospital, London, Ontario, Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation
- Study start
- Oct 2002
- Primary completion
- Dec 2006 (actual)
- First posted
- 1 Sep 2005 (estimated)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly admitted patients with a diagnosis of stroke (refer to eligibility criteria)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Toronto Bedside Swallowing Screening Test (TOR-BSST)Toronto Bedside Swallowing Screening Test | Device | – |
Primary outcome
Not reported in the source record.
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 1 Nov 2016.
- Background: PubMed 16269630Martino 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.
- Background: PubMed 10594255Martino 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.
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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.
Rosemary Martino, PhD principal investigator
University of Toronto
Nicholas E Diamant, MD principal investigator
University Health Network, Toronto
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident and Deglutition Disorders, run by University Health Network, Toronto at 5 sites in Canada.
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 2 inclusion and 5 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00141752, which also lists 2 linked publications.
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 1 Nov 2016.