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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?
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?
Secondary ID [1] 259976 0
none
Universal Trial Number (UTN)
U1111-1120-6697
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental coordination disorder 265602 0
Condition category
Condition code
Neurological 265747 265747 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 264388 0
Lifestyle
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.
Control group
Active

Outcomes
Primary outcome [1] 266506 0
Motor coordination assessed by Movement Assessement Battery for Children-2.
Timepoint [1] 266506 0
Baseline, post intervention period and post control period.
Primary outcome [2] 266507 0
Motor coordination during single leg stance
Timepoint [2] 266507 0
Baseline, post intervention period and post control period.
Primary outcome [3] 266564 0
Motor coordination during finger to nose to finger task
Timepoint [3] 266564 0
Baseline, post intervention period and post control period.
Secondary outcome [1] 273917 0
Motor coordination during run, jump, ball strike, ball kick, ball throw and catch
Timepoint [1] 273917 0
Baseline, post intervention period and post control period.
Secondary outcome [2] 273918 0
Motor coordination during PlayStation 3 Move Table Tennis and Archery and Xbox 360 Kinect Table Tennis and Soccer Kick tasks
Timepoint [2] 273918 0
Baseline, post intervention period and post control period.
Secondary outcome [3] 273920 0
Parent report of child coordination difficulties interfering with daily life will be assessed with the revised Developmental Coordination Questionnaire '07 (Wilson and Crawford 2010)
Timepoint [3] 273920 0
Baseline, post intervention period and post control period.
Secondary outcome [4] 273921 0
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.
Timepoint [4] 273921 0
Baseline, post intervention period and post control period.
Secondary outcome [5] 273922 0
Attitudes to physical activity will be assessed using the revised Physical Activity Enjoyment Scale.
Timepoint [5] 273922 0
Baseline, post intervention period and post control period.
Secondary outcome [6] 273923 0
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.
Timepoint [6] 273923 0
Baseline, post intervention period and post control period.
Secondary outcome [7] 273924 0
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.
Timepoint [7] 273924 0
Baseline, post intervention period and post control period.
Secondary outcome [8] 273925 0
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.
Timepoint [8] 273925 0
Baseline, post intervention period and post control period.

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.
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple alternating order.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Elligible volunteers participate in both conditions. Order is balance across participants.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2011
Actual
26/02/2011
Date of last participant enrolment
Anticipated
Actual
2/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 264853 0
Government body
Name [1] 264853 0
National Health and Medical Research Council
Country [1] 264853 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 264005 0
None
Name [1] 264005 0
Address [1] 264005 0
Country [1] 264005 0
Other collaborator category [1] 251936 0
University
Name [1] 251936 0
The University of Queensland
Address [1] 251936 0
St Lucia
Queensland 4072
Country [1] 251936 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266817 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 266817 0
GPO Box U1987
Perth WA 6845
Ethics committee country [1] 266817 0
Australia
Date submitted for ethics approval [1] 266817 0
Approval date [1] 266817 0
01/02/2011
Ethics approval number [1] 266817 0
HR11/2011

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.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 32469 0
Prof Leon Straker
Address 32469 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth WA 6845
Australia
Country 32469 0
Australia
Phone 32469 0
+61 8 92663634
Fax 32469 0
Email 32469 0
[email protected]
Contact person for public queries
Name 15716 0
Professor Leon Straker
Address 15716 0
School of Physiotherapy
Curtin University
GPO Box U1987
Perth WA 6845
Country 15716 0
Australia
Phone 15716 0
+61 8 9266 3634
Fax 15716 0
Email 15716 0
[email protected]
Contact person for scientific queries
Name 6644 0
Professor Leon Straker
Address 6644 0
School of Physiotherapy
Curtin University
GPO Box U1987
Perth WA 6845
Country 6644 0
Australia
Phone 6644 0
+61 8 9266 3634
Fax 6644 0
Email 6644 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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRationale, 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
EmbaseA 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.2015https://dx.doi.org/10.1016/j.humov.2015.04.011
EmbaseUnderstanding 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?.2017https://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.