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Trial registered on ANZCTR


Registration number
ACTRN12618002026202
Ethics application status
Approved
Date submitted
10/12/2018
Date registered
18/12/2018
Date last updated
23/04/2019
Date data sharing statement initially provided
18/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Vibration therapy for cerebral palsy children
Scientific title
The role of vibration therapy in improving the health and mobility of young children with cerebral palsy.
Secondary ID [1] 296636 0
Nil known
Universal Trial Number (UTN)
U1111-1224-1416
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 310463 0
Condition category
Condition code
Neurological 309176 309176 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will perform vibration therapy using the Galileo Basic vibration plates (Novotec Medical, Pforzheim, Germany). Each session will last 18 min: 3 min vibration followed by 3 minutes rest- repeated 3 times. Sessions will be performed 4 times a week, over 20- week periods. Each intervention group will have their own target intensity: either 20 or 25 Hz.
Training sessions will be performed at home or at school. An exercise physiologist from the research team will supervise the participants performing training at home once a week and all 4 days of the week for those doing it at school, in order to monitor progress and provide feedback/support. Parents/caregivers will provide ongoing supervision of home sessions.
Intervention code [1] 312945 0
Treatment: Devices
Comparator / control treatment
Before the intervention period, all participants will have a control period (lead-in) for 12 weeks. 12 week control period is the main comparator to assess the effects of two different vibration therapy protocols (20 Hz and 25 Hz).

During the control period, participants will continue their usual activity levels and standard care with no vibration therapy.
Control group
Dose comparison

Outcomes
Primary outcome [1] 308148 0
Mobility as assessed by the 6-minute walk test
Timepoint [1] 308148 0
Baseline (T0); after 12 weeks of control period (T1); after 12 weeks of vibration therapy (T2); after completing 20 weeks of vibration therapy (T3) (primary endpoint); in 12 weeks after finishing intervention period (T4).
Secondary outcome [1] 354078 0
Body composition assessed by Dual Energy X-Ray Absorptiometry (DEXA scan)
Timepoint [1] 354078 0
Baseline (T0); after 12 weeks of control period (T1); after 12 weeks of vibration therapy (T2); after completing 20 weeks of vibration therapy (T3); in 12 weeks after finishing intervention period (T4).
Secondary outcome [2] 354079 0
Gross motor function assessed by Gross motor function measure, dimension D and E
Timepoint [2] 354079 0
Baseline (T0); after 12 weeks of control period (T1); after 12 weeks of vibration therapy (T2); after completing 20 weeks of vibration therapy (T3); in 12 weeks after finishing intervention period (T4).
Secondary outcome [3] 354080 0
Muscle function assessed by jump power using the Leonardo mechanography force plate
Timepoint [3] 354080 0
Baseline (T0); after 12 weeks of control period (T1); after 12 weeks of vibration therapy (T2); after completing 20 weeks of vibration therapy (T3); in 12 weeks after finishing intervention period (T4).
Secondary outcome [4] 354081 0
Balance assessed by using the Leonardo mechanography force plate
Timepoint [4] 354081 0
Baseline (T0); after 12 weeks of control period (T1); after 12 weeks of vibration therapy (T2); after completing 20 weeks of vibration therapy (T3); in 12 weeks after finishing intervention period (T4).
Secondary outcome [5] 354082 0
Muscle strength assessed by using hand-held dynamometer (MicroFET2)
Timepoint [5] 354082 0
Baseline (T0); after 12 weeks of control period (T1); after 12 weeks of vibration therapy (T2); after completing 20 weeks of vibration therapy (T3); in 12 weeks after finishing intervention period (T4).
Secondary outcome [6] 354083 0
Respiratory function using a portable spirometer (Micromed)
Timepoint [6] 354083 0
Baseline (T0); after 12 weeks of control period (T1); after 12 weeks of vibration therapy (T2); after completing 20 weeks of vibration therapy (T3); in 12 weeks after finishing intervention period (T4).
Secondary outcome [7] 354084 0
Quality of life questionnaire assessed by the Cerebral Palsy Quality of Life Questionnaire for Primary Caregiver (CP QOL)
Timepoint [7] 354084 0
Baseline (T0); after 12 weeks of control period (T1); after 12 weeks of vibration therapy (T2); after completing 20 weeks of vibration therapy (T3); in 12 weeks after finishing intervention period (T4).
Secondary outcome [8] 354089 0
Physical Activity assessed by using Physical Activity Monitor (ActivPal).
Timepoint [8] 354089 0
Baseline (T0); after 12 weeks of control period (T1); after 12 weeks of vibration therapy (T2); after completing 20 weeks of vibration therapy (T3); in 12 weeks after finishing intervention period (T4).
Participants will wear a physical activity monitor for 5 days following their assessment

Eligibility
Key inclusion criteria
- Have diagnosed cerebral palsy with GMFCS I - III
- Be able to safely stand on the vibration platform
- Be able to understand the researcher’s instructions and follow them
Minimum age
5 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A bone fracture within 12 weeks of enrolment
- Acute thrombosis, tendinitis, nephrolithiasis, discopathy or arthritis
- 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.
- 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.
- History of botulinum toxin injection into lower limbs within 3 months of enrollment

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
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] 21044 0
New Zealand
State/province [1] 21044 0

Funding & Sponsors
Funding source category [1] 301214 0
University
Name [1] 301214 0
University of Auckland, Liggins Institute
Address [1] 301214 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland, 1023
Country [1] 301214 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] 301129 0
None
Name [1] 301129 0
Address [1] 301129 0
Country [1] 301129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301959 0
Health and Disability Ethics Committees (HDECs)
Ethics committee address [1] 301959 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 301959 0
New Zealand
Date submitted for ethics approval [1] 301959 0
10/01/2019
Approval date [1] 301959 0
16/04/2019
Ethics approval number [1] 301959 0

Summary
Brief summary
Cerebral palsy (CP) is the most common disability in childhood. CP is characterized by impaired mobility, which depends on muscle mass and spasticity. Therefore, one of the major focuses of therapy in CP children is to increase muscle mass and power, decrease spasticity and consequently improve mobility, weight bearing and bone health. Unfortunately, there is a void in therapeutic interventions aimed at increasing muscle mass and function, bone mass in CP children. Vibration therapy (VT) has the potential to fill this therapeutic gap. A recent extensive study using vibration therapy in adolescents with CP has shown improvements in mobility, bone strength, and muscle mass. We assume that younger children may benefit similar or even more due to their growth and development period. There is however sparse information regarding the use of vibration therapy in younger individuals with CP and robust study designs and assessments are required. This study aims to identify the benefits of VT in children with CP aged 5-12 years old and identify the best protocol of the VT for this age group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88674 0
Prof Paul Hofman
Address 88674 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 88674 0
New Zealand
Phone 88674 0
+64 09 923 6453
Fax 88674 0
Email 88674 0
p.hofman@auckland.ac.nz
Contact person for public queries
Name 88675 0
Mrs Alena Adaikina
Address 88675 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 88675 0
New Zealand
Phone 88675 0
+64 9 236098
Fax 88675 0
Email 88675 0
a.adaikina@auckland.ac.nz
Contact person for scientific queries
Name 88676 0
Mrs Alena Adaikina
Address 88676 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland 1023
Country 88676 0
New Zealand
Phone 88676 0
+64 9 236098
Fax 88676 0
Email 88676 0
a.adaikina@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
No Results