NCT00141752

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Last Updated

November 1, 2016

Status Verified

January 1, 2012

Enrollment Period

4.2 years

First QC Date

August 30, 2005

Last Update Submit

October 31, 2016

Conditions

Cerebrovascular AccidentDeglutition Disorders

Keywords

Cerebrovascular AccidentDeglutition Disordersstrokedysphagiascreening

Interventions

Toronto Bedside Swallowing Screening Test (TOR-BSST)DEVICE

Toronto Bedside Swallowing Screening Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Newly admitted patients with a diagnosis of stroke (refer to eligibility criteria)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Parkwood Hospital

London, Ontario, N6C 5J1, Canada

Location

Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

Location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Related 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. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.

    PMID: 16269630BACKGROUND

  • 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.

    PMID: 10594255BACKGROUND

MeSH Terms

Conditions

StrokeDeglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Rosemary Martino, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • Nicholas E Diamant, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

October 1, 2002

Primary Completion

December 1, 2006

Last Updated

November 1, 2016

Record last verified: 2012-01

Locations

CA(5)