Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001137987
Ethics application status
Approved
Date submitted
19/08/2020
Date registered
2/11/2020
Date last updated
6/04/2022
Date data sharing statement initially provided
2/11/2020
Date results information initially provided
6/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Posterior Cervical Spine Muscle Vibration and Oculomotor Function in Young Adults with Mild Traumatic Brain Injury (mTBI).
Scientific title
Oculomotor Function after Posterior Cervical Spine Muscle Vibration in Young Adults with Mild Traumatic Brain Injury
Secondary ID [1] 302080 0
U1111-1233-0051
Universal Trial Number (UTN)
U1111-1233-0051
Trial acronym
CVOmMTBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Traumatic Brain Injury 318688 0
Cervical spine dysfunction 318689 0
Condition category
Condition code
Neurological 316699 316699 0 0
Other neurological disorders
Injuries and Accidents 316700 316700 0 0
Other injuries and accidents
Musculoskeletal 316701 316701 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will undergo a single session of five minutes of 100hz vibration on the posterior upper cervical spinal muscles. The Vibration will be delivered by a cross-shaped unit Myovolt unit (https://myovolt.com/wearable-sports-recovery-technology) held in place with a velcro strap around the head. The intervention requires no specialist knowledge to apply and will be administered by the research assistant.
Intervention code [1] 318378 0
Rehabilitation
Comparator / control treatment
Healthy young adults will receive the same intervention administered by the research assistant
Control group
Active

Outcomes
Primary outcome [1] 324830 0
Composite primary outcome - Oculomotor: saccades, anti-saccades, fixations, smooth pursuits, pupillary dynamics, optokinetic reflex, multisensory integration and egocentric localisation using the Tobii eye tracker - a computerised measure of eye movements. All oculomotor outcomes are recorded by the Tobii eye tracker in XML document format.
Timepoint [1] 324830 0
immediately before and immediately after the intervention
Secondary outcome [1] 387574 0
Cervical spine flexion-relaxation ratio - measured using surface electromyography of the muscles of the posterior cervical spine. Two electrodes are placed in the lower and upper cervical spine and the participant is asked the flex their head forward fully then return their head to a neutral position. Surface electromyography recordings are taken of muscle activity in this procedure and stored electronically. The recordings will be taken by the research assistant.
Timepoint [1] 387574 0
Directly pre intervention only

Eligibility
Key inclusion criteria
20 Young adults with no history of mild traumatic brain injury (mTBI) and normal or corrected to normal vision
20 Young adults with mild traumatic brain injury (mTBI) and normal or corrected to normal vision
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any conditions that are known to affect eye-movements, such as Attention Deficit Hyperactivity Disorder (ADHD), stroke or cranial nerve palsy or vision loss in one or both eyes that is not corrected to normal via glasses or contact lenses.

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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations showed the need for a minimum number of 17 subjects per group (ß = 0.95, a = 0.05, effect size of 0.6). To allow for a relative uncertainty about the expected effect sizes, we aim to enrol a maximum of 40 participants in this trial.
Descriptive statistics such as unadjusted means, standard deviations, and counts will be used to describe the baseline characteristics of the two groups. Mixed models for repeated measures method will be used to analyse the effect of vibration on the change scores recorded pre and post intervention for the primary outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2020
Actual
13/04/2021
Date of last participant enrolment
Anticipated
4/01/2021
Actual
1/08/2021
Date of last data collection
Anticipated
4/01/2021
Actual
31/08/2021
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 22864 0
New Zealand
State/province [1] 22864 0
Auckland

Funding & Sponsors
Funding source category [1] 306499 0
University
Name [1] 306499 0
University of Auckland
Country [1] 306499 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
School of Optometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 307026 0
Individual
Name [1] 307026 0
Dr Kelly Jones
Address [1] 307026 0
Faculty of Health & Environmental Sciences
National Institute for Stroke and Applied Neurosciences
AUT University
Private Bag 92006
Auckland 1142
Country [1] 307026 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306704 0
Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 306704 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 306704 0
New Zealand
Date submitted for ethics approval [1] 306704 0
21/05/2019
Approval date [1] 306704 0
21/08/2019
Ethics approval number [1] 306704 0
19/CEN/130

Summary
Brief summary
This study utilises the eye tracking tests for testing eye movements in participants with a history of mTBI before and after vibration stimulation to the neck. These results will be compared to eye tracking tests in healthy participants with no history of mTBI. The vibration stimuli will test the hypothesis that aberrant sensory information from the neck (the vibration stimuli) affects eye movements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104730 0
Dr Phil Turnbull
Address 104730 0
The University of Auckland, School of VOptometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
Country 104730 0
New Zealand
Phone 104730 0
+64 9 373 7599
Fax 104730 0
Email 104730 0
[email protected]
Contact person for public queries
Name 104731 0
Ms Alice Cade
Address 104731 0
The University of Auckland, School of VOptometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
Country 104731 0
New Zealand
Phone 104731 0
+64 21 400 739
Fax 104731 0
Email 104731 0
[email protected]
Contact person for scientific queries
Name 104732 0
Ms Alice Cade
Address 104732 0
The University of Auckland, School of VOptometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
Country 104732 0
New Zealand
Phone 104732 0
+64 21 400 739
Fax 104732 0
Email 104732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data of primary and secondary outcomes only
When will data be available (start and end dates)?
Start date: 10/01/2021
End date: 10/01/2027
Available to whom?
Public
Available for what types of analyses?
Reproducing similar studies
How or where can data be obtained?
emailing the principal investigator: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3882Basic resultsNo 380418-(Uploaded-10-01-2023-12-40-00)-Basic results summary.docx
4152Plain language summaryNo Mild traumatic brain injury (mTBI) is a common and... [More Details]

Documents added automatically
No additional documents have been identified.