ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618002026202

Ethics application status

Approved

Date submitted

10/12/2018

Date registered

18/12/2018

Date last updated

1/06/2022

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]

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

Condition category

Condition code

Neurological

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]

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]

Mobility as assessed by the 6-minute walk test

Timepoint [1]

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]

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

Timepoint [1]

Secondary outcome [2]

Gross motor function assessed by Gross motor function measure, dimension D and E

Timepoint [2]

Secondary outcome [3]

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

Timepoint [3]

Secondary outcome [4]

Balance assessed by using the Leonardo mechanography force plate

Timepoint [4]

Secondary outcome [5]

Muscle strength assessed by using hand-held dynamometer (MicroFET2)

Timepoint [5]

Secondary outcome [6]

Respiratory function using a portable spirometer (Micromed)

Timepoint [6]

Secondary outcome [7]

Quality of life questionnaire assessed by the Cerebral Palsy Quality of Life Questionnaire for Primary Caregiver (CP QOL)

Timepoint [7]

Secondary outcome [8]

Physical Activity assessed by using Physical Activity Monitor (ActivPal).

Timepoint [8]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

1/05/2019

Actual

8/05/2019

Date of last participant enrolment

Anticipated

Actual

13/03/2021

Date of last data collection

Anticipated

23/10/2021

Actual

23/10/2021

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Auckland, Liggins Institute

Address [1]

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

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]

Health and Disability Ethics Committees (HDECs)

Ethics committee address [1]

Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

10/01/2019

Approval date [1]

16/04/2019

Ethics approval number [1]

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

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 protected]

Contact person for public queries

Name

Alena Adaikina

Address

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

Country

New Zealand

Phone

+64 9 236098

Fax

[email protected]

Contact person for scientific queries

Name

Alena Adaikina

Address

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

Country

New Zealand

Phone

+64 9 236098

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9957	Study protocol					376404-(Uploaded-03-07-2020-10-12-23)-Study-related document.pdf

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	The effect of side-alternating vibration therapy on mobility and health outcomes in young children with mild to moderate cerebral palsy: design and rationale for the randomized controlled study.	2020	https://dx.doi.org/10.1186/s12887-020-02377-2
Embase	Vibration therapy in young children with mild to moderate cerebral palsy: does frequency and treatment duration matter? A randomised-controlled study.	2023	https://dx.doi.org/10.1186/s12887-022-03786-1

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

Trial Review

Documents added manually

Documents added automatically