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Outcomes of Swallowing Rehabilitation After Stroke

NCT ID: NCT00288834

Last Updated: 2006-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2006-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Stroke Cerebrovascular Accident Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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dysphagia rehabilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role collaborator

Fremantle Hospital and Health Service

OTHER

Sponsor Role collaborator

Austin Hospital, Melbourne Australia

OTHER

Sponsor Role collaborator

University of Canterbury

OTHER

Sponsor Role lead

Principal Investigators

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Maggie-Lee Huckabee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Canterbury, Van der Veer Institute for Parkinson's and Brain Research, Christchurch New Zealand

Catriona M. Steele, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Toronto Rehabilitation Institute, Toronto Canada

Pascal van Lieshout, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, Toronto Canada

Locations

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Austin and Repatriation Medical Centre

Melbourne, Victoria, Australia

Site Status

Fremantle Hospital

Fremantle, Western Australia, Australia

Site Status

Glenrose Rehabilitation Centre

Edmonton, Alberta, Canada

Site Status

Deer Lodge Centre

Winnipeg, Manitoba, Canada

Site Status

Leonard Miller Rehabilitation Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Site Status

Trillium Health Centre

Mississauga, Ontario, Canada

Site Status

Princess Margaret Hospital

Christchurch, , New Zealand

Site Status

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Countries

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Australia Canada New Zealand Singapore

Other Identifiers

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NZ CMRF 01/10

Identifier Type: -

Identifier Source: secondary_id

HSF NA 4992

Identifier Type: -

Identifier Source: org_study_id