Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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8 November 2021 |
Main ID: |
ACTRN12605000585628 |
Date of registration:
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04/10/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Brain adaptation associated with spontaneous and training-induced recovery of touch sensation post-stroke.
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Scientific title:
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Brain adaptation associated with spontaneous and training-induced recovery of touch sensation post-stroke. |
Date of first enrolment:
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15/05/2004 |
Target sample size:
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45 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12605000585628.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Professor Leeanne Carey
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Address:
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National Stroke Research Institute
Austin Health
Repatriation Campus
Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081
Australia |
Telephone:
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+61 3 9496 2586 |
Email:
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lcarey@nsri.org.au |
Affiliation:
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Name:
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Professor Leeanne Carey
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Address:
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National Stroke Research Institute
Austin Health
Repatriation Campus
Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081
Australia |
Telephone:
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+61 3 94962586 |
Email:
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lcarey@nsri.org.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria:
Age minimum:
Not stated
Age maximum:
Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Stroke -
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Stroke; Stroke
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Intervention(s)
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The aim of this project is to locate and compare areas of brain activation associated with spontaneous (Study 1) and training-induced (Study 2) recovery of touch sensation following stroke, using serial functional magnetic resonance imaging (fMRI). Intervention involves stimulus specific training of touch sensation and includes graded presentation of stimuli, active exploration, feedback and calibration of sensations. Training is conducted for 15 x 45 minute sessions over a 6 week interval.
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Primary Outcome(s)
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The primary outcome is extent of activation, particularly in ipsilesional primary somatosensory cortex and bilateral secondary somatosensory cortex. This will be assessed between 1 and 6-month scans post-stroke for Study 1 and between 6 and 7.5-month scans post-stroke for Study 2.[Assessed between 1 and 6-month scans post-stroke for Study 1 and between 6 and 7.5-month scans post-stroke for Study 2.]
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The primary outcome is change in intensity, particularly in ipsilesional primary somatosensory cortex and bilateral secondary somatosensory cortex. [Assessed between 1 and 6-month scans post-stroke for Study 1 and between 6 and 7.5-month scans post-stroke for Study 2.]
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Secondary Outcome(s)
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Neurological function will be measured using the Neurological Institute Stroke Scale and activities of daily living using the Barthel Index.[At 1, 6 and 7.5 months.]
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Clinical measures of touch sensation, i.e texture discrimination using the Tactile Discrimination Test and detection of touch pressure using the WEST hand monofilaments.[These are assessed at 1, 3, 4.5, 6 and 7.5 months post-stroke.]
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Source(s) of Monetary Support
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NHMRC
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Ethics review
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Status: Approved
Approval date: 07/12/2001
Contact:
Austin Health
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Status: Approved
Approval date: 23/11/2004
Contact:
Northern Health
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Status: Approved
Approval date: 12/04/2005
Contact:
Eastern Health
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Status: Approved
Approval date: 10/08/2005
Contact:
Donvale Rehabilitation Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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