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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00141752
Other study ID # CSN II.10
Secondary ID
Status Completed
Phase N/A
First received August 30, 2005
Last updated October 31, 2016
Start date October 2002

Study information

Verified date January 2012
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 311
Est. completion date
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Toronto Bedside Swallowing Screening Test (TOR-BSST)
Toronto Bedside Swallowing Screening Test

Locations

Country Name City State
Canada Hamilton General Hospital Hamilton Ontario
Canada Parkwood Hospital London Ontario
Canada Sunnybrook and Women's College Health Sciences Centre Toronto Ontario
Canada Toronto Rehabilitation Institute Toronto Ontario
Canada Toronto Western Hospital, University Health Network Toronto Ontario

Sponsors (6)

Lead Sponsor Collaborator
University Health Network, Toronto Canadian Stroke Network, Hamilton Health Sciences Corporation, Parkwood Hospital, London, Ontario, Sunnybrook Health Sciences Centre, Toronto Rehabilitation Institute

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. Review. — View Citation

Martino R, Pron G, Diamant N. Screening for oropharyngeal dysphagia in stroke: insufficient evidence for guidelines. Dysphagia. 2000 Winter;15(1):19-30. — View Citation

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