World Health Organization site
Skip Navigation Links

Main
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: ANZCTR
Last refreshed on: 8 November 2021
Main ID:  ACTRN12605000585628
Date of registration: 04/10/2005
Prospective Registration: No
Primary sponsor: National Stroke Research Institute
Public title: Brain adaptation associated with spontaneous and training-induced recovery of touch sensation post-stroke.
Scientific title: Brain adaptation associated with spontaneous and training-induced recovery of touch sensation post-stroke.
Date of first enrolment: 15/05/2004
Target sample size: 45
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12605000585628.aspx
Study type:  Interventional
Study design:  Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase: 
Countries of recruitment
Australia
Contacts
Name: Professor Leeanne Carey   
Address:  National Stroke Research Institute Austin Health Repatriation Campus Neurosciences Building 300 Waterdale Road Heidelberg Heights VIC 3081 Australia
Telephone: +61 3 9496 2586
Email: lcarey@nsri.org.au
Affiliation: 
Name: Professor Leeanne Carey   
Address:  National Stroke Research Institute Austin Health Repatriation Campus Neurosciences Building 300 Waterdale Road Heidelberg Heights VIC 3081 Australia
Telephone: +61 3 94962586
Email: lcarey@nsri.org.au
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
Exclusion criteria:

Age minimum: Not stated
Age maximum: Not stated
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Stroke -
Stroke;
Stroke
Intervention(s)
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.
Primary Outcome(s)
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.]
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.]
Secondary Outcome(s)
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.]
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.]
Secondary ID(s)
Source(s) of Monetary Support
NHMRC
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 07/12/2001
Contact:
Austin Health
Status: Approved
Approval date: 23/11/2004
Contact:
Northern Health
Status: Approved
Approval date: 12/04/2005
Contact:
Eastern Health
Status: Approved
Approval date: 10/08/2005
Contact:
Donvale Rehabilitation Hospital
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history