Trial Review

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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] 294147 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuromuscular function 306773 0
Condition category
Condition code
Neurological 305868 305868 0 0
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] 300435 0
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] 304911 0
Primary Outcome: Change in H reflex following whole body vibration compared with the pretest value. Determined using EMG.
Timepoint [1] 304911 0
Baseline, immediately post-whole body vibration.
Secondary outcome [1] 343762 0
Inhibitory pathways will be explored using transcranial magnetic brain stimulation.
Timepoint [1] 343762 0
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
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 21655 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 298781 0
University
Name [1] 298781 0
Curtin University
Country [1] 298781 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley.,Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 297964 0
None
Name [1] 297964 0
Address [1] 297964 0
Country [1] 297964 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299727 0
Human Ethics Research Committee, Curtin University
Ethics committee address [1] 299727 0
Ethics committee country [1] 299727 0
Australia
Date submitted for ethics approval [1] 299727 0
23/02/2018
Approval date [1] 299727 0
Ethics approval number [1] 299727 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81386 0
Dr Andrew Lavender
Address 81386 0
School of Physiotherapy and Exercise Science
Curtin University
Kent Street, Bentley, 6102, W.A.
Country 81386 0
Australia
Phone 81386 0
+61 8 9266 3678
Fax 81386 0
Email 81386 0
[email protected]
Contact person for public queries
Name 81387 0
Andrew Lavender
Address 81387 0
School of Physiotherapy and Exercise Science
Curtin University
Kent Street, Bentley, 6102, W.A.
Country 81387 0
Australia
Phone 81387 0
+61 8 9266 3678
Fax 81387 0
Email 81387 0
[email protected]
Contact person for scientific queries
Name 81388 0
Andrew Lavender
Address 81388 0
School of Physiotherapy and Exercise Science
Curtin University
Kent Street, Bentley, 6102, W.A.
Country 81388 0
Australia
Phone 81388 0
+61 8 9266 3678
Fax 81388 0
Email 81388 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.