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Trial registered on ANZCTR


Registration number
ACTRN12611000465954
Ethics application status
Approved
Date submitted
5/05/2011
Date registered
5/05/2011
Date last updated
24/10/2019
Date data sharing statement initially provided
16/11/2018
Date results information initially provided
24/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can whole body vibration training improve muscle function and bone density in children and adolescents with cerebral palsy?
Scientific title
The effects of whole body vibration training on muscle function and bone density in children and adolescents with cerebral palsy.
Secondary ID [1] 260115 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 265780 0
Condition category
Condition code
Neurological 265934 265934 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participantswill perform whole body vibration training (WBVT) four times a week for 20 weeks. Each training session consists of three 3 minute WBVT with 3 minute short breaks between each WBVT. WBVT requires the participant to stand on a vibration plaque that moves rapidly (10-20Hz) up and down over a small distance (up to 10mm) generating vibration stimulus. The vibration causes the muscles in the legs and body to contract.
Intervention code [1] 264520 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266695 0
Peak Jump Force assessed by the Single Two-Legged Jump on the Leonardo ground reaction force plates.
Timepoint [1] 266695 0
Baseline and 20 weeks after randomisation
Primary outcome [2] 266696 0
Bone mineral density of the non-dominant Tibia assessed by Peripheral Quantitative Computer tomography (pQCT scan)
Timepoint [2] 266696 0
Baseline and 20 weeks after randomisation
Secondary outcome [1] 276208 0
Body composition assessed by Dual Energy X-Ray Absorptiometry (DEXA scan)
Timepoint [1] 276208 0
Baseline and 20 weeks after randomisation
Secondary outcome [2] 276210 0
Muscle strenght assessed by Chair raise test and 6 minute walk test
Timepoint [2] 276210 0
Baseline and 20 weeks after randomisation
Secondary outcome [3] 276211 0
Quality of life assessed by CP QOL questionnaire.
Timepoint [3] 276211 0
Baseline and 20 weeks after randomisation
Secondary outcome [4] 276212 0
Gait analysis assessed by 3D camera model.
Timepoint [4] 276212 0
Baseline and 20 weeks after randomisation

Eligibility
Key inclusion criteria
Children and adolescents with cerebral palsy (GMFCS II, III and IV) aged between 8 and 20 years. To be included in the study participants must be able to stand on vibration platform and be able to undertake evaluation of the therapy.
Minimum age
8 Years
Maximum age
20 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if: 1) they have a fracture of any type within 8 weeks of enrollment, pregnancy and acute thrombosis, muscle or tendom inflammation, renal stones, discopathy or arthritis. 2) there is history of clinically significant organic disease or findings on physical examination, which in the opinion of the investigator would prevent the patient from completing the study. 3) There is history of using any of the following medications, regardless of dose, for at least 1 month, within 3 months of enrollment: anabolic agents, glucocorticoids (does not include inhaled glucocorticoids) or growth hormone. 4) serum 25-hydroxyvitamin D < 50mmol/L 5) received Botulinium toxin injection into lower limbs within 3 months of enrollment. Participants will not receive Botolinium toxin injection throughout duration of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3569 0
New Zealand
State/province [1] 3569 0

Funding & Sponsors
Funding source category [1] 265016 0
Charities/Societies/Foundations
Name [1] 265016 0
Jubille Trust Funding
Address [1] 265016 0
The Jubille Trustess
C/-CCS Disability Action
PO Box 6450, Wellesley St
Auckland 1141
Country [1] 265016 0
New Zealand
Primary sponsor type
Individual
Name
Dr Paul Hofman
Address
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 264110 0
None
Name [1] 264110 0
Address [1] 264110 0
Country [1] 264110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266991 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 266991 0
Ministry of Health
3rd Floor, Unisys Building
650 Great South Rd, Penrose
Auckland 1051
Ethics committee country [1] 266991 0
New Zealand
Date submitted for ethics approval [1] 266991 0
22/04/2011
Approval date [1] 266991 0
22/09/2011
Ethics approval number [1] 266991 0

Summary
Brief summary
Cerebral palsy (CP) is the most common disability in childhood. CP is characterized by reduced muscle mass, impaired mobility and low bone density. Therefore, one of the major focuses of therapy in CP children is to increase muscle mass and power, thereby increasing mobility, weight bearing and bone health. Unfortunetely, there is a void in therapeutic interventions aimed at increasing muscle mass, muscle function as well as bone mass in CP children. Whole body vibration training (WBVT) has the potential to fill this therapeutic void. WBVT studies in healthy adults and postmenopausal females have been shown to enhance muscle function and bone health. However, it is unclear whether children with CP would benefit from WBVT. By maintaining muscle mass and bone mineral accrual during growth; WBVT can maximize mobility and bone strenght into adult life improving both mobility and quality of life. The proposed study aims to determine the effect of 20 weeks of WBVT on muscle and bone in children with CP. This should lead to improved health and well-being of children with CP. Further, it would open the way to improve the quality of life of a large number of disabled children with other disorders associated with reduced muscle mass.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32564 0
Prof Paul Hofman
Address 32564 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 32564 0
New Zealand
Phone 32564 0
+64 09 9236453
Fax 32564 0
Email 32564 0
p.hofman@auckalnd.ac.nz
Contact person for public queries
Name 15811 0
Dr Silmara Gusso
Address 15811 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 15811 0
New Zealand
Phone 15811 0
+64 09 9233795
Fax 15811 0
+64 09 373 8763
Email 15811 0
s.gusso@auckland.ac.nz
Contact person for scientific queries
Name 6739 0
Prof Dr Paul Hofman
Address 6739 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 6739 0
New Zealand
Phone 6739 0
+64 09 3737599 Ext 86453
Fax 6739 0
+64 09 373 8763
Email 6739 0
p.hofman@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 5457 0
03 March 2016
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary