ANZCTR - Registration

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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

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Motor disability ( muscle-skeletal disability)

Spina Bifida

Genetic/disease motor disorder

Injury related motor disorder

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Neurological

Other neurological disorders

Human Genetics and Inherited Disorders

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]

Treatment: Devices

Comparator / control treatment

Single subject design

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Bone mineral density of non-dominant tibia by Peripheral Quantitative Computer Tomography (pQCT scan)

Timepoint [1]

baseline and 20 weeks after baseline

Primary outcome [2]

Body composition assessed by Dual Energy X-Ray Absorptiometry (DEXA scan)

Timepoint [2]

baseline and 20 weeks after baseline

Secondary outcome [1]

muscle function assessed by chair rise using the Leonardo mechanography force plate.

Timepoint [1]

baseline and 20 weeks after baseline

Secondary outcome [2]

Muscle function assessed by jump power using the Leonardo mechanography force plate.

Timepoint [2]

baseline and 20 weeks after baseline

Secondary outcome [3]

Muscle function assessed by both feet balance and one foot balance using the Leonardo mechanography force plate.

Timepoint [3]

baseline and 20 weeks after baseline

Secondary outcome [4]

Muscle function assessed by the distance walked in 6 minutes using the 6 minutes walk test.

Timepoint [4]

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]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Jubilee Trust Funding

Address [1]

The Jubilee Trustees
C/-CCS disability action
PO Box 6450, Wellesley St
Auckland 1141

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern A Health and Disability Ethics Committee.

Ethics committee address [1]

Ministry of Health
1 the Terrace
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

22/02/2013

Ethics approval number [1]

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

Prof Paul Hofman

Address

University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland, 1023

Country

New Zealand

Phone

+ 64 09 923 6453

Fax

Email

p.hofman@auckalnd.ac.nz

Contact person for public queries

Name

Silmara Gusso

Address

University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland, 1023

Country

New Zealand

Phone

+64 09 923 3795

Fax

Email

s.gusso@auckland.ac.nz

Contact person for scientific queries

Name

Paul Hofman

Address

University of Auckland
Liggins Institute
85 Park Rd, Grafton
Auckland, 1023

Country

New Zealand

Phone

+64 09 923 6453

Fax

Email

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

Source	Title	Year of Publication	DOI
Embase	Feasibility study on a longer side-alternating vibration therapy protocol (15 min per session) in children and adolescents with mild cerebral palsy.	2023	https://dx.doi.org/10.3389/fped.2023.1231068

N.B. These documents automatically identified may not have been verified by the study sponsor.