NCT00288834

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

  1. 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. 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2001

Longer than P75 for not_applicable stroke

Geographic Reach
4 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

February 8, 2006

Status Verified

February 1, 2006

First QC Date

February 6, 2006

Last Update Submit

February 6, 2006

Conditions

StrokeCerebrovascular AccidentDysphagia

Keywords

strokedysphagiarehabilitationbiofeedback

Outcome Measures

Primary Outcomes (4)

  • 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.

Interventions

dysphagia rehabilitationBEHAVIORAL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • history of pre-existing dysphagia or neurologic disease prior to the onset of the current disorder.
  • MMSE score \< 21

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Austin and Repatriation Medical Centre

Melbourne, Victoria, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, Australia

Location

Glenrose Rehabilitation Centre

Edmonton, Alberta, Canada

Location

Deer Lodge Centre

Winnipeg, Manitoba, Canada

Location

Leonard Miller Rehabilitation Centre

St. John's, Newfoundland and Labrador, Canada

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Location

Trillium Health Centre

Mississauga, Ontario, Canada

Location

Princess Margaret Hospital

Christchurch, New Zealand

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

StrokeDeglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 8, 2006

Study Start

August 1, 2001

Study Completion

July 1, 2006

Last Updated

February 8, 2006

Record last verified: 2006-02

Locations

SG(1)CA(5)AU(2)NZ(1)