Outcomes of Swallowing Rehabilitation After Stroke

February 6, 2006 updated by: University of Canterbury

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • Austin and Repatriation Medical Centre
    • Western Australia
      • Fremantle, Western Australia, Australia
        • Fremantle Hospital
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Glenrose Rehabilitation Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Deer Lodge Centre
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Leonard Miller Rehabilitation Centre
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Health Sciences Centre
      • Mississauga, Ontario, Canada
        • Trillium Health Centre
  • New Zealand
      • Christchurch, New Zealand
        • Princess Margaret Hospital
  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Canterbury

Collaborators

Tan Tock Seng Hospital
University of Toronto
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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (Estimate)

February 8, 2006

Study Record Updates

Last Update Posted (Estimate)

February 8, 2006

Last Update Submitted That Met QC Criteria

February 6, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSF NA 4992
  • NZ CMRF 01/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on dysphagia rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe