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Outcomes of Swallowing Rehabilitation After Stroke
This study has been completed.
Study NCT00288834.   Last updated on February 6, 2006.
Information provided by University of Canterbury
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Outcomes of Swallowing Rehabilitation After Stroke
Outcomes of Swallowing Rehabilitation After Stroke

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

  1. The utilization of SEMG biofeedback monitoring in dysphagia rehabilitation facilitates more rapid and complete recovery than traditional rehabilitation using the same swallowing exercises without exteroceptive feedback.
  2. Swallowing rehabilitation provided in an intensive rehabilitative programme (10 hrs of treatment in the 1st week) facilitates more rapid and complete recovery than traditionally scheduled swallowing rehabilitation (twice weekly).

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.

Interventional
Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
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.
 
Stroke
Cerebrovascular Accident
Dysphagia
Behavioral: dysphagia rehabilitation
 
Completed
 
August 2001
July 2006

Inclusion Criteria:

  • Subjects will represent the diagnostic categories of single event brain stem injury, right cortical stroke and left cortical stroke.
  • Chronic dysphagia at least 6 months post onset secondary to single neurological event, brain stem, right cortical or left cortical stroke confirmed with CT or MRI
  • Diagnosis of chronic pharyngeal phase dysphagia based on clinical and videofluoroscopic evaluation completed within 3 weeks of beginning treatment.
  • Must be at least 12 months post onset with no substantial recovery of swallowing function. If patients have received prior swallowing treatment, they must be at least three months post the termination of direct treatment.
  • Mini Mental Status Exam score >21

Exclusion Criteria:

  • history of pre-existing dysphagia or neurologic disease prior to the onset of the current disorder.
  • MMSE score < 21
Both
21 Years and older
No
Australia,   Canada,   New Zealand,   Singapore
 
NCT00288834
HSF NA 4992
NZ CMRF 01/10
University of Canterbury
University of Toronto
Tan Tock Seng Hospital, Singapore
Fremantle Hospital and Health Service
Austin Hospital, Melbourne Australia
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
University of Canterbury
February 2006
February 6, 2006
February 6, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.