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Outcomes of Swallowing Rehabilitation After Stroke

Primary Purpose

Stroke, Cerebrovascular Accident, Dysphagia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
dysphagia rehabilitation
Sponsored by
University of Canterbury
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, dysphagia, rehabilitation, biofeedback

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Austin and Repatriation Medical Centre
  • Fremantle Hospital
  • Glenrose Rehabilitation Centre
  • Deer Lodge Centre
  • Leonard Miller Rehabilitation Centre
  • Hamilton Health Sciences Centre
  • Trillium Health Centre
  • Princess Margaret Hospital
  • Tan Tock Seng Hospital

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2006
Last Updated
February 6, 2006
Sponsor
University of Canterbury
Collaborators
University of Toronto, Tan Tock Seng Hospital, Fremantle Hospital and Health Service, Austin Hospital, Melbourne Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00288834
Brief Title
Outcomes of Swallowing Rehabilitation After Stroke
Official Title
Outcomes of Swallowing Rehabilitation After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Canterbury
Collaborators
University of Toronto, Tan Tock Seng Hospital, Fremantle Hospital and Health Service, Austin Hospital, Melbourne Australia

4. Oversight

5. 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. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident, Dysphagia
Keywords
stroke, dysphagia, rehabilitation, biofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
dysphagia rehabilitation
Primary Outcome Measure Information:
Title
The following outcomes measures will be assessed after 10. 20 and 30 therapeutic sessions:
Title
Severity rankings of swallowing pathophysiology based on videofluoroscopic swallowing studies Videofluoroscopic swallowing studies
Title
Functional outcome ratings of associated clinical parameters (respiratory, neurological status, self help, cognitive)
Title
Quality of life ratings (SwalQOL) In addition, quality of life ratings (SwalQOL) will be assessed at one follow-up assessment six months post discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maggie-Lee Huckabee, Ph.D.
Organizational Affiliation
University of Canterbury, Van der Veer Institute for Parkinson's and Brain Research, Christchurch New Zealand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catriona M. Steele, Ph.D.
Organizational Affiliation
Toronto Rehabilitation Institute, Toronto Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascal van Lieshout, Ph.D.
Organizational Affiliation
University of Toronto, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin and Repatriation Medical Centre
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
Country
Australia
Facility Name
Glenrose Rehabilitation Centre
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Deer Lodge Centre
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Leonard Miller Rehabilitation Centre
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Hamilton Health Sciences Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Trillium Health Centre
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Princess Margaret Hospital
City
Christchurch
Country
New Zealand
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

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Outcomes of Swallowing Rehabilitation After Stroke

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