Outcomes of Swallowing Rehabilitation After Stroke
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Purpose
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
- 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.
- 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).
| Condition | Intervention |
|---|---|
|
Stroke Cerebrovascular Accident Dysphagia |
Behavioral: dysphagia rehabilitation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Outcomes of Swallowing Rehabilitation After Stroke |
- 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.
| 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 | |
| Hamilton Health Sciences Centre | |
| Hamilton, Ontario, Canada | |
| Trillium Health Centre | |
| Mississauga, 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00288834 History of Changes |
| Other Study ID Numbers: | HSF NA 4992, NZ CMRF 01/10 |
| Study First Received: | February 6, 2006 |
| Last Updated: | February 6, 2006 |
| Health Authority: | New Zealand: Health Research Council |
Keywords provided by University of Canterbury:
|
stroke dysphagia rehabilitation biofeedback |
Additional relevant MeSH terms:
|
Deglutition Disorders Cerebral Infarction Stroke Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases |
Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013