Outcomes of Swallowing Rehabilitation After Stroke

Sponsor

University of Canterbury (Other)

Overall Status

Completed

CT.gov ID

NCT00288834

Collaborator

University of Toronto (Other), Tan Tock Seng Hospital (Other), Fremantle Hospital and Health Service (Other), Austin Hospital, Melbourne Australia (Other)

Locations

Duration (Months)

Study Details

Study Description

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.

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 or Disease	Intervention/Treatment	Phase
Stroke Cerebrovascular Accident Dysphagia	Behavioral: dysphagia rehabilitation	N/A

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Outcomes of Swallowing Rehabilitation After Stroke

Study Start Date :

Aug 1, 2001

Study Completion Date :

Jul 1, 2006

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Austin and Repatriation Medical Centre	Melbourne	Victoria	Australia
2	Fremantle Hospital	Fremantle	Western Australia	Australia
3	Glenrose Rehabilitation Centre	Edmonton	Alberta	Canada
4	Deer Lodge Centre	Winnipeg	Manitoba	Canada
5	Leonard Miller Rehabilitation Centre	St. John's	Newfoundland and Labrador	Canada
6	Hamilton Health Sciences Centre	Hamilton	Ontario	Canada
7	Trillium Health Centre	Mississauga	Ontario	Canada
8	Princess Margaret Hospital	Christchurch		New Zealand
9	Tan Tock Seng Hospital	Singapore		Singapore

Sponsors and Collaborators

University of Canterbury
University of Toronto
Tan Tock Seng Hospital
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