NCT00257764

Brief Summary

Swallowing dysfunction after stroke is common, but there is no reliable evidence for how it should be managed other than perhaps by nasogastric tube. This study compared the effectiveness of standardised, low and high intensity behavioral intervention for dysphagia with that of "usual care".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 1996

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

May 1, 1996

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1999

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
Last Updated

May 5, 2006

Status Verified

June 1, 1999

First QC Date

November 21, 2005

Last Update Submit

May 4, 2006

Conditions

Dysphagia

Keywords

Swallowing disorderStrokeStandardized swallowing therapyRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • survival free of an abnormal diet at 6 months

Secondary Outcomes (3)

  • time to return to normal diet over the study

  • recovery of swallowing ability at 6 months after stroke

  • the occurrence of dysphagia - related medical complications at 6 months.

Interventions

behavioral swallowing exercises/ strategiesBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of stroke within the previous 7 days
  • clinical diagnosis of swallowing difficulty

You may not qualify if:

  • no previous history of swallowing treatment
  • no previous history of surgery of the head or neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Related Publications (1)

  • Carnaby G, Hankey GJ, Pizzi J. Behavioural intervention for dysphagia in acute stroke: a randomised controlled trial. Lancet Neurol. 2006 Jan;5(1):31-7. doi: 10.1016/S1474-4422(05)70252-0.

    PMID: 16361020RESULT

MeSH Terms

Conditions

Deglutition DisordersStroke

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Graeme Hankey, MBBS, MD,

    Royal Perth Hospital

    STUDY DIRECTOR

  • Giselle D Mann, MPH,PhD

    Royal Perth Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2005

First Posted

November 23, 2005

Study Start

May 1, 1996

Study Completion

May 1, 1999

Last Updated

May 5, 2006

Record last verified: 1999-06

Locations

AU(1)