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Sponsors and Collaborators: |
University of Canterbury University of Toronto Tan Tock Seng Hospital, Singapore Fremantle Hospital and Health Service Austin Hospital, Melbourne Australia |
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Information provided by: | University of Canterbury |
ClinicalTrials.gov Identifier: | NCT00288834 |
This project proposes to evaluate the relative effectiveness of four therapy protocols for pharyngeal phase swallowing impairment in the stroke population. Data derived from this study should contribute significantly to our understanding of the rehabilitative process in the neurogenic dysphagic population and will provide the foundation for the establishment of efficacious, cost-efficient patient services.
1. Research Question to be addressed
Condition | Intervention |
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Stroke Cerebrovascular Accident Dysphagia |
Behavioral: dysphagia rehabilitation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Outcomes of Swallowing Rehabilitation After Stroke |
Study Start Date: | August 2001 |
Estimated Study Completion Date: | July 2006 |
This multi-site, multi-national project will evaluate the relative effectiveness of four therapy protocols for pharyngeal phase swallowing impairment in the stroke population. For this study, patients with chronic dysphagia secondary to stroke will be assigned to one of four treatment protocols. These four protocols differ in respect to the intensity of treatment and the inclusion of surface electromyography (SEMG) biofeedback as an adjunct to treatment. All patients will complete a total of 30 hours of therapy with data collection to assess progress at intervals of every 10 sessions. Treatment outcomes will be measured using a combination of physiologic and behavioral measures. Data derived from this study should contribute significantly to our understanding of the rehabilitative process in the neurogenic dysphagic population and will provide the foundation for the establishment of efficacious, cost-efficient patient services.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, Victoria | |
Austin and Repatriation Medical Centre | |
Melbourne, Victoria, Australia | |
Australia, Western Australia | |
Fremantle Hospital | |
Fremantle, Western Australia, Australia | |
Canada, Alberta | |
Glenrose Rehabilitation Centre | |
Edmonton, Alberta, Canada | |
Canada, Manitoba | |
Deer Lodge Centre | |
Winnipeg, Manitoba, Canada | |
Canada, Newfoundland and Labrador | |
Leonard Miller Rehabilitation Centre | |
St. John's, Newfoundland and Labrador, Canada | |
Canada, Ontario | |
Trillium Health Centre | |
Mississauga, Ontario, Canada | |
Hamilton Health Sciences Centre | |
Hamilton, Ontario, Canada | |
New Zealand | |
Princess Margaret Hospital | |
Christchurch, New Zealand | |
Singapore | |
Tan Tock Seng Hospital | |
Singapore, Singapore |
Principal Investigator: | Maggie-Lee Huckabee, Ph.D. | University of Canterbury, Van der Veer Institute for Parkinson's and Brain Research, Christchurch New Zealand |
Principal Investigator: | Catriona M. Steele, Ph.D. | Toronto Rehabilitation Institute, Toronto Canada |
Principal Investigator: | Pascal van Lieshout, Ph.D. | University of Toronto, Toronto Canada |
Study ID Numbers: | HSF NA 4992, NZ CMRF 01/10 |
Study First Received: | February 6, 2006 |
Last Updated: | February 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00288834 |
Health Authority: | New Zealand: Health Research Council |
stroke dysphagia rehabilitation biofeedback |
Otorhinolaryngologic Diseases Esophageal disorder Cerebral Infarction Gastrointestinal Diseases Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases |
Pharyngeal Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Brain Ischemia Esophageal Diseases Brain Infarction Infarction |
Nervous System Diseases Cardiovascular Diseases |