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Trial registered on ANZCTR
Registration number
ACTRN12611000400965
Ethics application status
Approved
Date submitted
15/04/2011
Date registered
15/04/2011
Date last updated
14/04/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
Can use of active virtual reality games improve motor competence in children with developmental coordination disorder?
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Scientific title
Among children with developmental coordination disorder, does use of active virtual reality games lead to improved motor competence, physical activity and mental health?
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Secondary ID [1]
259976
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none
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Universal Trial Number (UTN)
U1111-1120-6697
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Developmental coordination disorder
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Condition category
Condition code
Neurological
265747
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
‘Active electronic games’ will involve the provision of a Sony PlayStation 3 with Move and Eye input devices and Microsoft Xbox360 with Kinect input device and a range of non-violent games for 16 weeks. PlayStation 3 games include: Sports Champions, Start the Party, TV Superstars and EyePet. Xbox360 games include: Kinect Sports, Motion Sports, Kinect Adventures, Sonic - Free Riders, Dance Central and Dr Kawashima's Body and Brain Exercises.
Children are requested to play these games for at least 20 minutes each day for at least 5 days a week. Actual dose is monitored by children keeping a diary and regular phone calls to the children to record the diary data at study headquarters.
Half of the children start with this condition then crossover to the control condition and half will follow the opposite order. There will be no real wash-out period between conditions as outcomes measures from the end of the 16 week conditions will be used.
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Intervention code [1]
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Lifestyle
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Comparator / control treatment
‘No active electronic games’ will involve all active input electronic games being removed from the family home with a contract that active electronic games will be avoided where possible at other locations for 16 weeks. Other than avoidance of active electronic games, participants will play games as they would without involvment in the study - ie their usual activities. This will include the ability to play any gamesbe able to play traditional electronic games using a game pad input during this period provided the family usually had this equipment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Motor coordination assessed by Movement Assessement Battery for Children-2.
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Assessment method [1]
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Timepoint [1]
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Baseline, post intervention period and post control period.
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Primary outcome [2]
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Motor coordination during single leg stance
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Assessment method [2]
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Timepoint [2]
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Baseline, post intervention period and post control period.
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Primary outcome [3]
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Motor coordination during finger to nose to finger task
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Assessment method [3]
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Timepoint [3]
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Baseline, post intervention period and post control period.
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Secondary outcome [1]
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Motor coordination during run, jump, ball strike, ball kick, ball throw and catch
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Assessment method [1]
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Timepoint [1]
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Baseline, post intervention period and post control period.
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Secondary outcome [2]
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Motor coordination during PlayStation 3 Move Table Tennis and Archery and Xbox 360 Kinect Table Tennis and Soccer Kick tasks
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Assessment method [2]
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Timepoint [2]
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Baseline, post intervention period and post control period.
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Secondary outcome [3]
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Parent report of child coordination difficulties interfering with daily life will be assessed with the revised Developmental Coordination Questionnaire '07 (Wilson and Crawford 2010)
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Assessment method [3]
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Timepoint [3]
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Baseline, post intervention period and post control period.
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Secondary outcome [4]
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Physical activity. Time spent in sedentary, light and moderate to vigorous intensity physical activity, as well as total movement, will be assessed over 7 days using Actical accelerometers worn on the hip. Total weekly physical activity as well as weekend physical activity and after school weekday physical activity will be assessed.
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Assessment method [4]
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Timepoint [4]
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Baseline, post intervention period and post control period.
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Secondary outcome [5]
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Attitudes to physical activity will be assessed using the revised Physical Activity Enjoyment Scale.
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Assessment method [5]
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Timepoint [5]
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Baseline, post intervention period and post control period.
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Secondary outcome [6]
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Self perceptions will be assessed using Harter's Self-Perception Profile for Children (Harter 1985) across domains of Scholastic Competence, Social Acceptance, Athletic Competence, Physical Appearance and Behavioural Conduct, and a subscale designed to evaluate global self-worth that assesses self-esteem independent from the competence domains.
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Assessment method [6]
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Timepoint [6]
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Baseline, post intervention period and post control period.
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Secondary outcome [7]
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Anxiety will be assessed using Spence Children's Anxiety Scale (Spence 1997) across six subscales, namely panic attack and agoraphobia, separation anxiety disorder, social phobia, physical injury fears, obsessive compulsive disorder, and generalized anxiety disorder.
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Assessment method [7]
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Timepoint [7]
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Baseline, post intervention period and post control period.
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Secondary outcome [8]
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Depressive symptoms will be assessed using the Moods and Feelings Questionnaire - short Form (Angold et al. 1995) that covers areas such as affective, vegetative and cognitive symptoms of depression.
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Assessment method [8]
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Timepoint [8]
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Baseline, post intervention period and post control period.
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Eligibility
Key inclusion criteria
Scoring in the bottom 15 percent on the Movement Assessment Battery for Children - version 2.
Otherwise healthy.
Able to play electronic games on most days.
Metropolitan Perth.
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Minimum age
10
Years
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Maximum age
12
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Diagnosed disorder likely to impact on coordination, study participation or electronic game use.
Live in a shared arrangement where child spends a significant amount of time in different houses and is unable to maintain game access.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants recruited in response to newspaper, radio and school notices. Allocated to randomised and balanced ordering of intervention and control period based on sequential recruitment. Allocation was not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple alternating order.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
Elligible volunteers participate in both conditions. Order is balance across participants.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/02/2011
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Actual
26/02/2011
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Date of last participant enrolment
Anticipated
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Actual
2/04/2011
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
21
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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GPO Box 1421
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Curtin University
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Address
GPO Box U1987
Perth WA 6845
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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University
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Name [1]
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The University of Queensland
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Address [1]
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St Lucia
Queensland 4072
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Curtin University Human Research Ethics Committee
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Ethics committee address [1]
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GPO Box U1987 Perth WA 6845
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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01/02/2011
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Ethics approval number [1]
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HR11/2011
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Summary
Brief summary
Background A healthy start to life requires adequate motor development and physical activity participation. Currently 5-15% of children have impaired motor development without any obvious disorder. These children are at greater risk of obesity, musculoskeletal disorders, low social confidence and poor mental health. Traditional electronic game use may impact on motor development and physical activity creating a vicious cycle. However new virtual reality (VR) game interfaces may provide motor experiences that enhance motor development and lead to an increase in motor coordination and better physical activity and mental health outcomes. VR games are beginning to be used for rehabilitation, however there is no reported trial of the impact of these games on motor coordination in children with developmental coordination disorder. Methods This cross-over randomised and controlled trial will examine whether motor coordination is enhanced by access to active electronic games and whether daily activity, attitudes to physical activity and mental health are also enhanced. Thirty children aged 10-12 years with poor motor coordination (below 15th percentile) will be recruited and randomised to a balanced ordering of ‘no active electronic games’ and ‘active’ electronic games. Each child will participate in both conditions for 16 weeks, and be assessed prior to participation and at the end of each condition. The primary outcome is motor coordination, assessed by kinematic and kinetic motion analysis laboratory measures. Physical activity and sedentariness will be assessed by accelerometry, coordination in daily life by parent report questionnaire and attitudes to physical activity, self-confidence, anxiety and depressed mood will be assessed by self report questionnaire. Discussion This is the first trial to examine the impact of new virtual reality games on motor coordination in children with developmental coordination disorder. The findings will provide critical information to understand whether these electronic games can be used to have a positive impact on the physical and mental health of these children. Given the importance of adequate motor coordination, physical activity and mental health in childhood, this project can inform interventions which could have a profound impact on the long term health of this group of children.
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Trial website
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Trial related presentations / publications
Straker, L., Howie, E., Smith, A., Jensen, L., Piek, J., & Campbell, A. (2015). A crossover randomised and controlled trial of the impact of active video games on motor coordination and perceptions of physical ability in children with developmental coordination disorder. Human Movement Science, 42, 146-160. Larke, D., Campbell, A., Jensen, L., & Straker, L. (2015). The responsiveness of clinical and laboratory measures for detecting intervention effects in children with DCD. Paediatric Physical Therapy, 27(1), 44-51. Gonsalves, L., Campbell, A., Jensen, L., & Straker, L. (2015). Children with Developmental Coordination Disorder play active virtual reality games differently to typically developing children. Physical Therapy, 95(3), 360-368. Bufton, A., A. Campbell, E. Howie and L. Straker (2014). A comparison of the upper limb movement kinematics utilized by children playing virtual and real table tennis. Human Movement Science 38: 84-93. Maddison, R., Straker, L., Palmeira, A., Simons, M., Hansen, L., & Thin, A. (2013). Active video games - an opportunity for enhanced learning and positive health effects? Cognitive Technology Journal, 18(1), 6-13. Straker, L., Fenner, A., Howie, E., Feltz, D., Gray, C., Lu, A.,Mueller,F. & Barnett, L. (2015). Efficient and effective change principles in Active Video Games. Games for Health, 4(1), 43-52.
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Public notes
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Contacts
Principal investigator
Name
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Prof Leon Straker
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Address
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School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth WA 6845
Australia
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Country
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Australia
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Phone
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+61 8 92663634
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Professor Leon Straker
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Address
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School of Physiotherapy
Curtin University
GPO Box U1987
Perth WA 6845
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Country
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Australia
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Phone
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+61 8 9266 3634
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Professor Leon Straker
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Address
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School of Physiotherapy
Curtin University
GPO Box U1987
Perth WA 6845
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Country
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Australia
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Phone
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+61 8 9266 3634
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Fax
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Email
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Rationale, design and methods for a randomised and controlled trial of the impact of virtual reality games on motor competence, physical activity, and mental health in children with developmental coordination disorder.
2011
Embase
A crossover randomised and controlled trial of the impact of active video games on motor coordination and perceptions of physical ability in children at risk of Developmental Coordination Disorder.
2015
https://dx.doi.org/10.1016/j.humov.2015.04.011
Embase
Understanding why an active video game intervention did not improve motor skill and physical activity in children with developmental coordination disorder: A quantity or quality issue?.
2017
https://dx.doi.org/10.1016/j.ridd.2016.10.013
N.B. These documents automatically identified may not have been verified by the study sponsor.
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