Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000092594
Ethics application status
Approved
Date submitted
20/01/2015
Date registered
4/02/2015
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Date results information initially provided
16/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can 5 months of whole body vibration therapy improve muscle function and bone density in adolescents with motor disability?
Scientific title
The effects of whole body vibration therapy on muscle and bone health in adolescents with motor disability.
Secondary ID [1] 286000 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor disability ( muscle-skeletal disability) 293960 0
Spina Bifida 294060 0
Genetic/disease motor disorder 294061 0
Injury related motor disorder 294062 0
Condition category
Condition code
Musculoskeletal 294257 294257 0 0
Other muscular and skeletal disorders
Neurological 294258 294258 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 294360 294360 0 0
Other human genetics and inherited 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 three 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 truck to contract. Training sessions performed at schools are supervised by a physiotherapist. Training sessions performed at home are supervised by parents/caregivers with orientation and weekly visits from physiotherapist.
Intervention code [1] 290978 0
Treatment: Devices
Comparator / control treatment
Single subject design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294056 0
Bone mineral density of non-dominant tibia by Peripheral Quantitative Computer Tomography (pQCT scan)
Timepoint [1] 294056 0
baseline and 20 weeks after baseline
Primary outcome [2] 294057 0
Body composition assessed by Dual Energy X-Ray Absorptiometry (DEXA scan)
Timepoint [2] 294057 0
baseline and 20 weeks after baseline
Secondary outcome [1] 312432 0
muscle function assessed by chair rise using the Leonardo mechanography force plate.
Timepoint [1] 312432 0
baseline and 20 weeks after baseline
Secondary outcome [2] 312642 0
Muscle function assessed by jump power using the Leonardo mechanography force plate.
Timepoint [2] 312642 0
baseline and 20 weeks after baseline
Secondary outcome [3] 312643 0
Muscle function assessed by both feet balance and one foot balance using the Leonardo mechanography force plate.
Timepoint [3] 312643 0
baseline and 20 weeks after baseline
Secondary outcome [4] 312644 0
Muscle function assessed by the distance walked in 6 minutes using the 6 minutes walk test.
Timepoint [4] 312644 0
baseline and 20 weeks after baseline

Eligibility
Key inclusion criteria
adolescents with heterogeneous motor disability that is not cerebral palsy ( GMFCS II-IV) aged between 10-20 years. This would include patients with: mild to moderate spina bifida, genetic/disease motor disorders and injury related motor disorder. 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
10 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/01/2015
Actual
20/01/2015
Date of last participant enrolment
Anticipated
Actual
30/03/2017
Date of last data collection
Anticipated
Actual
13/09/2018
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 6601 0
New Zealand
State/province [1] 6601 0
Auckland

Funding & Sponsors
Funding source category [1] 290593 0
Charities/Societies/Foundations
Name [1] 290593 0
Jubilee Trust Funding
Country [1] 290593 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] 289282 0
None
Name [1] 289282 0
Address [1] 289282 0
Country [1] 289282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292229 0
Northern A Health and Disability Ethics Committee.
Ethics committee address [1] 292229 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 292229 0
New Zealand
Date submitted for ethics approval [1] 292229 0
Approval date [1] 292229 0
22/02/2013
Ethics approval number [1] 292229 0

Summary
Brief summary
Children with other motor disabilities such as spina bifida, genetic motor disorders and injury related motor disorders have reduced muscle mass, impaired mobility and low bone density (osteopenia). While low bone density and fracture risk are multifactorial, muscle mass and weight bearing are two of the major factors affecting bone density. Therefore, one of the major focuses of therapy in poorly mobile children is to increase muscle mass and power, thereby increasing mobility, weight bearing and bone health. Unfortunately, there is a void in therapeutic interventions aimed at increasing muscle mass, muscle function as well as osteopaenia in these 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 power and mass when used alone or when added to standard exercise regimens. By maintaining muscle mass and bone mineral accrual during growth; WBVT can maximize mobility and bone strength 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 health in adolescents with heterogeneous locomotor disability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54206 0
Prof Paul Hofman
Address 54206 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland, 1023
Country 54206 0
New Zealand
Phone 54206 0
+ 64 09 923 6453
Fax 54206 0
Email 54206 0
p.hofman@auckalnd.ac.nz
Contact person for public queries
Name 54207 0
Dr Silmara Gusso
Address 54207 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland, 1023
Country 54207 0
New Zealand
Phone 54207 0
+64 09 923 3795
Fax 54207 0
Email 54207 0
s.gusso@auckland.ac.nz
Contact person for scientific queries
Name 54208 0
Prof Paul Hofman
Address 54208 0
University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland, 1023
Country 54208 0
New Zealand
Phone 54208 0
+64 09 923 6453
Fax 54208 0
Email 54208 0
p.hofman@auckalnd.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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
SourceTitleYear of PublicationDOI
EmbaseFeasibility study on a longer side-alternating vibration therapy protocol (15 min per session) in children and adolescents with mild cerebral palsy.2023https://dx.doi.org/10.3389/fped.2023.1231068
N.B. These documents automatically identified may not have been verified by the study sponsor.