Outcomes of Swallowing Rehabilitation After Stroke - Full Text View

Sponsors and Collaborators:	University of Canterbury University of Toronto Tan Tock Seng Hospital, Singapore Fremantle Hospital and Health Service Austin Hospital, Melbourne Australia
Information provided by:	University of Canterbury
ClinicalTrials.gov Identifier:	NCT00288834

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

MedlinePlus related topics: Rehabilitation Swallowing Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Outcomes of Swallowing Rehabilitation After Stroke

Further study details as provided by University of Canterbury:

Primary Outcome Measures:

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

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288834

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
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

Sponsors and Collaborators

University of Canterbury

University of Toronto

Tan Tock Seng Hospital, Singapore

Fremantle Hospital and Health Service

Austin Hospital, Melbourne Australia

Investigators

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

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

Keywords provided by University of Canterbury:

stroke
dysphagia
rehabilitation
biofeedback

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2009