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Brief Title † | Outcomes of Swallowing Rehabilitation After Stroke | ||||||||||||
Official Title † | Outcomes of Swallowing Rehabilitation After Stroke | ||||||||||||
Brief Summary | 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
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Detailed Description | 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. |
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Study Phase | |||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study | ||||||||||||
Primary Outcome Measure † | The following outcomes measures will be assessed after 10. 20 and 30 therapeutic sessions: Severity rankings of swallowing pathophysiology based on videofluoroscopic swallowing studies Videofluoroscopic swallowing studies Functional outcome ratings of associated clinical parameters (respiratory, neurological status, self help, cognitive) Quality of life ratings (SwalQOL) In addition, quality of life ratings (SwalQOL) will be assessed at one follow-up assessment six months post discharge. |
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Secondary Outcome Measure † | |||||||||||||
Condition † | Stroke Cerebrovascular Accident Dysphagia |
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Intervention † | Behavioral: dysphagia rehabilitation | ||||||||||||
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Recruitment Information Fields | |||||||||||||
Recruitment Status † | Completed | ||||||||||||
Enrollment † | |||||||||||||
Start Date † | August 2001 | ||||||||||||
Completion Date | July 2006 | ||||||||||||
Primary Completion Date | |||||||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||
Ages | 21 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | Australia, Canada, New Zealand, Singapore | ||||||||||||
Administrative Information Fields | |||||||||||||
NCT ID † | NCT00288834 | ||||||||||||
Organization ID | HSF NA 4992 | ||||||||||||
Secondary IDs †† | NZ CMRF 01/10 | ||||||||||||
Study Sponsor † | University of Canterbury | ||||||||||||
Collaborators †† | University of Toronto Tan Tock Seng Hospital, Singapore Fremantle Hospital and Health Service Austin Hospital, Melbourne Australia |
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Investigators † |
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Information Provided By | University of Canterbury | ||||||||||||
Verification Date | February 2006 | ||||||||||||
First Received Date † | February 6, 2006 | ||||||||||||
Last Updated Date | February 6, 2006 |