Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000585628
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
4/10/2005
Date last updated
2/11/2021
Date data sharing statement initially provided
2/11/2021
Type of registration
Retrospectively registered

Titles & IDs
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.
Universal Trial Number (UTN)
Trial acronym
IN_Touch
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 712 0
Condition category
Condition code
Stroke 789 789 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 573 0
Rehabilitation
Comparator / control treatment
The control condition involves exposure to similar touch stimuli over the same number of sessions but does not include training principles.
Control group
Placebo

Outcomes
Primary outcome [1] 1006 0
The primary outcome is change in intensity, particularly in ipsilesional primary somatosensory cortex and bilateral secondary somatosensory cortex.
Timepoint [1] 1006 0
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.
Primary outcome [2] 1007 0
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.
Timepoint [2] 1007 0
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 [1] 1897 0
Clinical measures of touch sensation, i.e texture discrimination using the Tactile Discrimination Test and detection of touch pressure using the WEST hand monofilaments.
Timepoint [1] 1897 0
These are assessed at 1, 3, 4.5, 6 and 7.5 months post-stroke.
Secondary outcome [2] 1898 0
Neurological function will be measured using the Neurological Institute Stroke Scale and activities of daily living using the Barthel Index.
Timepoint [2] 1898 0
At 1, 6 and 7.5 months.

Eligibility
Key inclusion criteria
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation. Independent notification via confidential email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generator with matching constraints.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2004
Actual
15/05/2004
Date of last participant enrolment
Anticipated
Actual
12/10/2007
Date of last data collection
Anticipated
Actual
12/04/2008
Sample size
Target
45
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 874 0
Government body
Name [1] 874 0
NHMRC
Country [1] 874 0
Australia
Primary sponsor type
Other
Name
National Stroke Research Institute
Address
Country
Australia
Secondary sponsor category [1] 740 0
None
Name [1] 740 0
Nil
Address [1] 740 0
Country [1] 740 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2156 0
Austin Health
Ethics committee address [1] 2156 0
Ethics committee country [1] 2156 0
Australia
Date submitted for ethics approval [1] 2156 0
Approval date [1] 2156 0
07/12/2001
Ethics approval number [1] 2156 0
Ethics committee name [2] 2157 0
Northern Health
Ethics committee address [2] 2157 0
Ethics committee country [2] 2157 0
Australia
Date submitted for ethics approval [2] 2157 0
Approval date [2] 2157 0
23/11/2004
Ethics approval number [2] 2157 0
Ethics committee name [3] 2158 0
Eastern Health
Ethics committee address [3] 2158 0
Ethics committee country [3] 2158 0
Australia
Date submitted for ethics approval [3] 2158 0
Approval date [3] 2158 0
12/04/2005
Ethics approval number [3] 2158 0
Ethics committee name [4] 2159 0
Donvale Rehabilitation Hospital
Ethics committee address [4] 2159 0
Ethics committee country [4] 2159 0
Australia
Date submitted for ethics approval [4] 2159 0
Approval date [4] 2159 0
10/08/2005
Ethics approval number [4] 2159 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35639 0
Address 35639 0
Country 35639 0
Phone 35639 0
Fax 35639 0
Email 35639 0
Contact person for public queries
Name 9762 0
Professor Leeanne Carey
Address 9762 0
National Stroke Research Institute
Austin Health
Repatriation Campus
Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081
Country 9762 0
Australia
Phone 9762 0
+61 3 9496 2586
Fax 9762 0
+61 3 9496 2650
Email 9762 0
[email protected]
Contact person for scientific queries
Name 690 0
Professor Leeanne Carey
Address 690 0
National Stroke Research Institute
Austin Health
Repatriation Campus
Neurosciences Building
300 Waterdale Road
Heidelberg Heights VIC 3081
Country 690 0
Australia
Phone 690 0
+61 3 94962586
Fax 690 0
+61 3 94962650
Email 690 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.