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Completed

NCT Number: NCT00288834

Outcomes of Swallowing Rehabilitation After Stroke

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).

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Austin and Repatriation Medical Centre, Melbourne, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dysphagia rehabilitation

Behavioral

Primary outcomes

  1. The following outcomes measures will be assessed after 10. 20 and 30 therapeutic sessions:

  2. Severity rankings of swallowing pathophysiology based on videofluoroscopic swallowing studies Videofluoroscopic swallowing studies

  3. Functional outcome ratings of associated clinical parameters (respiratory, neurological status, self help, cognitive)

  4. Quality of life ratings (SwalQOL) In addition, quality of life ratings (SwalQOL) will be assessed at one follow-up assessment six months post discharge.

Sponsors and collaborators

Lead sponsor

University of Canterbury

Other

Collaborators

  • Austin Hospital, Melbourne Australia
  • Fremantle Hospital and Health Service
  • Tan Tock Seng Hospital
  • University of Toronto

Registry information

Important dates

Study start
2001
Study completion
2006
First posted
Feb 8, 2006
Registry last updated
Feb 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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