Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000145505
Ethics application status
Approved
Date submitted
20/01/2015
Date registered
17/02/2015
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
Retrospectively registered

Titles & IDs
Public title
Can 15 minutes of whole body vibration therapy improve muscle and bone health in children and adolescents with cerebral palsy?
Scientific title
The effects of 15 minutes whole body vibration therapy on muscle function and bone density in children and adolescents with cerebral palsy
Secondary ID [1] 286002 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 293965 0
Condition category
Condition code
Neurological 294262 294262 0 0
Other neurological disorders
Musculoskeletal 294263 294263 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the study will perform whole body vibration therapy (WBVT) four times a week for 20 weeks. Each training session consists of five 3 minute WBVT with three minute rest breaks between each WBVT. Participants will weight bear (stand with or without aid) on a vibration plate that moves rapidly ( 12-22Hz) up and down over a small
distance ( up to 10 mm) generating vibration stimulus. The vibration causes the muscle in the leg and trunk to contract. Sessions will be perform at home or local school and will be supervised by an experienced physiotherapist. Each participant will have a training diary to log all sessions performed and the time/ intensity used. The diary will help to monitor the participants adherence to the training programme.
Intervention code [1] 290981 0
Treatment: Devices
Comparator / control treatment
single subject design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294059 0
Bone mineral density of the non-dominant Tibia assessed by Peripheral Quantitative Computer tomography (pQCT scan)
Timepoint [1] 294059 0
baseline and 20 weeks after baseline
Primary outcome [2] 294060 0
Body Composition assessed by DEXA scan
Timepoint [2] 294060 0
baseline and 20 weeks after baseline
Secondary outcome [1] 312434 0
muscle function assessed by chair rise test using a power plate ( Leonardo Mechanograph)
Timepoint [1] 312434 0
baseline and 20 weeks after baseline
Secondary outcome [2] 312903 0
Jump power assessed by power plate (Leonardo Mechanograph)
Timepoint [2] 312903 0
baseline and 20 weeks after baseline
Secondary outcome [3] 312904 0
muscle function assessed by balance test using a power plate ( Leonardo Mechanograph)
Timepoint [3] 312904 0
baseline and 20 weeks after baseline
Secondary outcome [4] 312905 0
muscle function assessed by the 6 minutes walk test
Timepoint [4] 312905 0
baseline and 20 weeks after baseline

Eligibility
Key inclusion criteria
Adolescents with cerebral palsy (GMFCS II-IV) aged between 8-20 years. To be included in the study participants must
be able to stand on the vibration plate ( with or without assistance) and be able to undertake evaluation assessments
Minimum age
8 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if:1)They have a fracture within 8 weeks of
enrolment, pregnancy and acute thrombosis, muscle or tendon
inflammation, renal stones, discopathy or arthritis. 2) There is a 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 a history of using any of the following
medications, regardless of dose, for at least 1 month, within 3 months of
enrolment: anabolic agents, glucocorticoids (does not include inhaled
glucocorticoids) or growth hormone. Participants will not receive Botulinium
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
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
20/01/2015
Actual
5/02/2015
Date of last participant enrolment
Anticipated
Actual
28/03/2019
Date of last data collection
Anticipated
Actual
27/08/2019
Sample size
Target
20
Accrual to date
Final
17
Recruitment outside Australia
Country [1] 6602 0
New Zealand
State/province [1] 6602 0

Funding & Sponsors
Funding source category [1] 290594 0
Charities/Societies/Foundations
Name [1] 290594 0
Jubilee Trust Funding
Country [1] 290594 0
New Zealand
Primary sponsor type
Individual
Name
Prof Paul Hofman
Address
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 289283 0
Individual
Name [1] 289283 0
Dr Silmara Gusso
Address [1] 289283 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country [1] 289283 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294220 0
Health and Disability Ethics Committee
Ethics committee address [1] 294220 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 294220 0
New Zealand
Date submitted for ethics approval [1] 294220 0
28/10/2014
Approval date [1] 294220 0
13/11/2014
Ethics approval number [1] 294220 0
NTX/11/05/042/AM04

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. Most studies have used 9 minutes of therapy per session. We aim to look at the impact of prolonged use (15 minutes) of vibration on muscle and bones. 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 by doing it for 15 minutes four times a week instead of the 9 minutes used in previous studies. This should lead to improved health and well-being of adolescents with CP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54218 0
Prof Paul Hofman
Address 54218 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 54218 0
New Zealand
Phone 54218 0
+64 09 9236453
Fax 54218 0
Email 54218 0
[email protected]
Contact person for public queries
Name 54219 0
Dr Silmara Gusso
Address 54219 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 54219 0
New Zealand
Phone 54219 0
+ 64 09 923 3795
Fax 54219 0
Email 54219 0
[email protected]
Contact person for scientific queries
Name 54220 0
Prof Paul Hofman
Address 54220 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 54220 0
New Zealand
Phone 54220 0
+ 64 09 923 6453
Fax 54220 0
Email 54220 0
[email protected]

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 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.