ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12618000380291p

Ethics application status

Submitted, not yet approved

Date submitted

23/02/2018

Date registered

14/03/2018

Date last updated

18/02/2019

Date data sharing statement initially provided

18/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of whole body vibration on cortical involvement in leg muscle contraction

Scientific title

Effects of whole body vibration on cortical involvement in leg muscle contraction in healthy adults

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Neuromuscular function

Condition category

Condition code

Neurological

Studies of the normal brain and nervous system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Volunteers will stand on a vibration platform for 5 minutes in 1 minute blocks with 30 seconds breaks between. Frequency will be 25-55 Hz at an amplitude of 4mm. EMG will be used to measure H reflex and M wave before and after the WBV by electrically stimulating the tibial nerve in blocks of 5 stmuli at least 10 seconds apart starting at 2mV intensity and gradually increasing the stimulus until the h reflex is elicited. The interval between blocks will be at least 15 seconds. Stimulation increase is continued and eventually the h reflex is no longer seen as the m wave continues to increase. Stimulation is stopped when the m wave reaches plateau, usually around 50 mA and up to 100 stimuli will be delivered before and another 100 after WBV. The threshold and intensity of the stimulus varies greatly between subjects. Cortical function will be measured by stimulating the motor cortex with transcranial magnetic brain stimulation. A PhD qualified Neuromuscular physiologist with more than 12 years experience will carry out all procedures.

Intervention code [1]

Other interventions

Comparator / control treatment

No control group. Measures will be made before and after volunteers stand on a vibration platform.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Primary Outcome: Change in H reflex following whole body vibration compared with the pretest value. Determined using EMG.

Timepoint [1]

Baseline, immediately post-whole body vibration.

Secondary outcome [1]

Inhibitory pathways will be explored using transcranial magnetic brain stimulation.

Timepoint [1]

Baseline, immediately post-whole body vibration.

Eligibility

Key inclusion criteria

Volunteers will be aged between 18 and 80 years and have no contraindications to electrical or magnetic stimulation or use of a whole body vibration platform.

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Use of a pacemaker, any neurological disorder including migraine and severe arthritis or other joint pain that may be exacerbated by whole body vibration.

Study design

Purpose of the study

Prevention

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

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Pre and post data will be compared using t tests and ANOVA's.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

15/03/2019

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6102 - Bentley

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

Kent Street, Bentley, Western Australia, 6102.

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University

Address

Kent Street, Bentley.,Western Australia, 6102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Human Ethics Research Committee, Curtin University

Ethics committee address [1]

Curtin University,
Kent Street, Bentley, W.A. 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/02/2018

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This experiment is designed to assess cortical and neuromuscular mechanisms involved in control of leg muscles and how these are modulated by standing on a vibration platform. The study will help us to understand the effect of whole body vibration on the contribution of cortical function and reflex pathways to maintaining balance during quiet standing. This may have implications with regard to prescription of whole body vibration for enhancing exercise prescription that leads to improved function of lower leg muscles for young and older individuals. This may have important implications for optimisation of exercise for strength, endurance and balance. Volunteers will attend the lab on two occasions. During one visit they will undergo transcranial magnetic stimulation in a standing position with feedback about their muscle activation level, and without the feedback. They will then stand on the vibration platform for 5 minutes with breaks after each minute and repeat the brain stimulation tests. On the second occasion they will lay on a massage table while the tibial nerve is stimulated with an electrical pulse to measure H reflex. They will again stand on the vibration platform for 5 minutes with breaks after each minute and repeat the H reflex test.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Andrew Lavender

Address

School of Physiotherapy and Exercise Science
Curtin University
Kent Street, Bentley, 6102, W.A.

Country

Australia

Phone

+61 8 9266 3678

Fax

andrew.lavender@curtin.edu.au

Contact person for public queries

Name

Andrew Lavender

Address

School of Physiotherapy and Exercise Science
Curtin University
Kent Street, Bentley, 6102, W.A.

Country

Australia

Phone

+61 8 9266 3678

Fax

andrew.lavender@curtin.edu.au

Contact person for scientific queries

Name

Andrew Lavender

Address

School of Physiotherapy and Exercise Science
Curtin University
Kent Street, Bentley, 6102, W.A.

Country

Australia

Phone

+61 8 9266 3678

Fax

andrew.lavender@curtin.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

No Data available.

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically