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Trial registered on ANZCTR


Registration number
ACTRN12612000186853
Ethics application status
Approved
Date submitted
9/02/2012
Date registered
10/02/2012
Date last updated
20/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining if a customised "in-home" computer gaming system can improve sensory function in the hands of children with cerebral palsy.
Scientific title
Assessing the prevalence of tactile sensory agnosia in the hands of children with cerebral palsy aged 5 to 15 years old, and investigating if a customised "in-home" computer gaming system can improve sensory function for those children who are known to have a sensory deficit compared to healthy, aged matched typically developing children.
Secondary ID [1] 279909 0
Nil.
Universal Trial Number (UTN)
U1111-1127-0623
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy (CP). 285817 0
Tactile sensory agnosia 285827 0
Condition category
Condition code
Neurological 285997 285997 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a customised computer gaming system, with a specialised joystick to enable and maximise access for children with cerebral palsy. The interactive gaming system provides haptic feedback to the user - the haptic feature can be enabled or disabled, depending on the group the child is randomised into. Children are asked to use the system for 1 hour per day, 7 days a week, for 6 weeks.
Intervention code [1] 284234 0
Treatment: Devices
Comparator / control treatment
Participants who are identified as having a tactile sensory loss in their hands (compared to healthy, age-matched, typically developing peers) will be randomised into either the active (haptic) group or the control group (which will not receive haptic feedback during game play).
Control group
Placebo

Outcomes
Primary outcome [1] 286486 0
Improved performance in the suite of sensory assessment measures. The assessment measures are: a test of stereognosis (using 12 everyday objects); a test of tactile discrimination; a test of proprioception (by moving the distal phalange either up or down); and a test of pressure sensitivity (using Semmes-Weinstein monofilaments).
Timepoint [1] 286486 0
At first baseline (entry to Stage 1), at second baseline (entry to Stage 2, week 1), at the conclusion of the 6-week computer gaming trial (10 weeks post second baseline), and at 4 weeks post trial (14 weeks post second baseline). The computer gaming trial begins in week 5 and concludes in week 10.
Secondary outcome [1] 296000 0
Improved performance in the measure of hand function, as measured using the Jebsen Taylor Hand Function Test.
Timepoint [1] 296000 0
At first baseline (entry to Stage 1), at second baseline (entry to Stage 2, week 1), at the conclusion of the 6-week computer gaming trial (10 weeks post second baseline), and at 4 weeks post trial (14 weeks post second baseline). The computer gaming trial begins in week 5 and concludes in week 10.

Eligibility
Key inclusion criteria
Children with a confirmed diagnosis of cerebral palsy who are aged 5-15 years, with no previous hand surgery, who have not received botulinum toxin A in the last 3 months, and who have the ability to follow and respond to verbal instructions.
Minimum age
5 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with a neurological condition other than cerebral palsy; children who are younger than 5 years of age or older than 15 years of age; children who have had hand surgery; children who have received botulinum toxin A within 3 months of stage 1 or within 3 months of stage 2; children who cannot follow and/or respond to verbal instructions.

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)
Stage 1 of the overall research project is a tactile sensory assessment and functional assessment of the hands of children with cerebral palsy aged between 5 and 15 years old. A sensory loss for participants in Stage 1 will be determined by comparing participants to healthy, age-matched typically developing peers. Recruitment for Stage 1 will be via the South Australian Cerebral Palsy Register in Adelaide. Participants who are identified as having a sensory loss will be invited to participate in Stage 2 - the intervention - which involves each participant using a customised in-home computer gaming system with a specialised joystick controller. Participants will be given the same computer gaming system and controller, receive instruction in it's use from the same researcher, and will be randomised into one of two groups: Group A, where the computer gaming system and controller has the haptic feature enabled, or Group B, where the computer gaming system and controller has the haptic feature disabled. Participants will be unaware that the other group has the haptic feature enabled or disabled. Allocation for the randomised controlled trial will be performed by a third party not involved with the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants will be assessed prior to beginning Stage 2. This assessment order (first, second, third, etc) will determine the order for randomisation. Randomisation will occur via a computer generated sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/06/2013
Actual
16/05/2013
Date of last participant enrolment
Anticipated
Actual
28/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284686 0
Hospital
Name [1] 284686 0
Women's and Children's Hospital Foundation (for Stage 1)
Country [1] 284686 0
Australia
Funding source category [2] 287500 0
Charities/Societies/Foundations
Name [2] 287500 0
The Channel 7 Children's Research Foundation of South Australia
Country [2] 287500 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Road
North Adelaide, SA, 5006
Country
Australia
Secondary sponsor category [1] 283587 0
University
Name [1] 283587 0
Flinders University
Address [1] 283587 0
Bedford Park Campus
Sturt Road,
Bedford Park, SA, 5042
Country [1] 283587 0
Australia
Other collaborator category [1] 260530 0
University
Name [1] 260530 0
University of South Australia
Address [1] 260530 0
City East Campus,
North Terrace, Adelaide, SA, 5000
Country [1] 260530 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286686 0
Women's and Children's Hospital Human Research Ethics Committee (for Stage 1)
Ethics committee address [1] 286686 0
Ethics committee country [1] 286686 0
Australia
Date submitted for ethics approval [1] 286686 0
Approval date [1] 286686 0
21/12/2011
Ethics approval number [1] 286686 0
REC2441/12/14
Ethics committee name [2] 286687 0
SA Health Human Research Ethics Committee (for Stage 1)
Ethics committee address [2] 286687 0
Ethics committee country [2] 286687 0
Australia
Date submitted for ethics approval [2] 286687 0
Approval date [2] 286687 0
08/02/2012
Ethics approval number [2] 286687 0
480/11/2014
Ethics committee name [3] 289477 0
Women's and Children's Hospital Human Research Ethics Committee (for Stage 2)
Ethics committee address [3] 289477 0
Ethics committee country [3] 289477 0
Australia
Date submitted for ethics approval [3] 289477 0
Approval date [3] 289477 0
12/12/2012
Ethics approval number [3] 289477 0
REC2530/12/15

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

Contacts
Principal investigator
Name 33756 0
Mr David Hobbs
Address 33756 0
Flinders University School of Computer Science, Engineering and Mathematics (CSEM) Sturt Road, Bedford Park, SA, 5042
Country 33756 0
Australia
Phone 33756 0
+61 8 8201 3167
Fax 33756 0
Email 33756 0
[email protected]
Contact person for public queries
Name 17003 0
David Hobbs
Address 17003 0
Flinders University
School of Computer Science, Engineering and Mathematics (CSEM)
Sturt Road,
Bedford Park, SA, 5042
Country 17003 0
Australia
Phone 17003 0
+61 8 8201 3167
Fax 17003 0
Email 17003 0
[email protected]
Contact person for scientific queries
Name 7931 0
Dr Ray Russo
Address 7931 0
Women's and Children's Health Network and Flinders University
72 King William Road
North Adelaide, SA, 5006
Country 7931 0
Australia
Phone 7931 0
+ 61 8 8161 7220
Fax 7931 0
Email 7931 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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