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Trial registered on ANZCTR
Registration number
ACTRN12613000023752
Ethics application status
Approved
Date submitted
8/01/2013
Date registered
9/01/2013
Date last updated
18/07/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
“Step up” – a pedometer based physical activity self-management program for children and adolescents with physical disability
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Scientific title
“Step up” – a pedometer based physical activity self-management program for children and adolescents with physical disability
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Secondary ID [1]
281737
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None
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Universal Trial Number (UTN)
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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:
Physical disability
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Condition category
Condition code
Public Health
288420
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0
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Other public health
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The “StepUp” intervention is an 6-week pedometer-based physical activity program for children with physical disabilities. It comprises
1. a 1 hr one-on-one counseling session with the participant, their parent and a Novita physiotherapist to introduce the StepUp materials,
2. a pedometer,
3. the “StepUp” booklet, which provides advice on the benefits of physical activity for children with disabilities, tips to increase physical activity specifically tailored to children with physical disabilities, and a 6-week log book to allow participants to record and track their progress. Participants will be asked to submit a copy of their step counts to the overseeing therapist weekly via mail or email.
4. 3 x fortnightly follow-up phone calls from the Novita therapist (approx. 5 minutes in duration) to provide support and answer questions.
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Intervention code [1]
286274
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Lifestyle
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Comparator / control treatment
Continue on with normal every day activities.
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Control group
Active
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Outcomes
Primary outcome [1]
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Objective physical activity (Actigraph GT3X+ accelerometery)
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Assessment method [1]
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Timepoint [1]
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Baseline, post-intervention (6 weeks) and 3 month follow-up
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Secondary outcome [1]
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Exercise intention (LEAP II exercise intention scale)
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Assessment method [1]
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Timepoint [1]
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Baseline, post-intervention (6 weeks) and 3 month follow-up
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Secondary outcome [2]
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Physical self-worth (Physical Self-worth Scale)
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Assessment method [2]
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Timepoint [2]
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Baseline, post-intervention and 3 month follow-up
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Secondary outcome [3]
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Quality of life (KINDL)
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Assessment method [3]
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Timepoint [3]
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Baseline, post-intervention and 3 month follow-up
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Eligibility
Key inclusion criteria
1. aged 8-17 years;
2. diagnosed as having a physical disability;
3. use ambulation as their main method of transport;
4. live in greater Adelaide; and
5. have sufficient cognitive ability to understand the program.
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Minimum age
8
Years
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Maximum age
17
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
1. use of wheelchair as main form of transport;
2. recent or planned orthopaedic surgery; and
3. injury impacting on ability to partake in physical activity.
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Study design
Purpose of the study
Educational / counselling / training
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
Parallel
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Other design features
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Phase
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Type of endpoint/s
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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
4/03/2013
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Actual
3/06/2013
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Date of last participant enrolment
Anticipated
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Actual
13/12/2013
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Date of last data collection
Anticipated
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Actual
31/03/2014
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Sample size
Target
70
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Accrual to date
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Final
59
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Channel 7 Children's Research Foundation
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Address [1]
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PO Box 2438
Regency Park SA 5942
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of South Australia
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Address
GPO Box 2471, Adelaide, SA 5001
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Country
Australia
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Secondary sponsor category [1]
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Charities/Societies/Foundations
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Name [1]
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Novita Children's Services
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Address [1]
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171 Days Road
Regency Park SA 5010
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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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University of South Australia Human research ethics committee
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Ethics committee address [1]
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PO Box 2471, Adelaide, SA 5001
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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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10/12/2012
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Ethics approval number [1]
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0000030989
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Summary
Brief summary
Physical activity is important for physical and psychological health, as well as for maintenance of physical function and independence in young people with physical disabilities. However, people with physical disabilities have difficulty finding appropriate avenues for physical activity. This project involves the development and evaluation of a novel and feasible pedometer-based physical activity self-management program for young people with physical disability. Given its low-cost, low-touch nature, once developed, this program could be readily incorporated into ongoing clinical services.
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Trial website
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Trial related presentations / publications
Maher, C., Crettenden, A., Evans, K., Thiessen, M., Toohey, M., Watson, A., & Dollman, J. (2015). Fatigue is a major issue for children and adolescents with physical disabilities. Developmental Medicine & Child Neurology, 57(8), 742-747.
Maher, C., Crettenden, A., Evans, K., Thiessen, M., Toohey, M., & Dollman, J. (2014). A pedometer based physical activity self-management program for children and adolescents with physical disability–design and methods of the StepUp study. BMC pediatrics, 14(1), 31.
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Public notes
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Contacts
Principal investigator
Name
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Dr Carol Maher
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Address
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Health and Use of Time Group, School of Health Sciences
C7-41, City East Campus, University of South Australia
GPO Box 2471, Adelaide SA 5001
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Country
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Australia
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Phone
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+61 08 8302 2315
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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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Dr Carol Maher
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Address
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Health and Use of Time Group, School of Health Sciences
C7-41, City East Campus, University of South Australia
GPO Box 2471, Adelaide SA 5001
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Country
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Australia
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Phone
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+61 08 8302 2315
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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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Dr Carol Maher
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Address
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Health and Use of Time Group, School of Health Sciences
C7-41, City East Campus, University of South Australia
GPO Box 2471, Adelaide SA 5001
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Country
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Australia
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Phone
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+61 08 8302 2315
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Fax
36868
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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
No additional documents have been identified.
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