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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02733055
Registration number
NCT02733055
Ethics application status
Date submitted
5/04/2016
Date registered
11/04/2016
Titles & IDs
Public title
Posturography as Biomarker of Oculomotor and Postural Control Integration
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Scientific title
Posturography as Biomarker of Oculomotor and Postural Control Integration
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Secondary ID [1]
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CI-IRB-20160321002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postural Balance
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - posturographic evaluation
Experimental: subjects - participant undergoing posturographic evaluation
Other interventions: posturographic evaluation
subjects will undergo CDP testing using one of the ext_mCTSIB tests without (baseline) and with oculomotor task
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Stability Score
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Assessment method [1]
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The Stability Score (calculated as percentage ratio of the actual sway and the theoretical limit of stability) will be used to investigate if there is any difference between the test without and with oculomotor task. Statistical tools such t-tests and correlation coefficients will be used to assess if there is a difference between the two tests
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Timepoint [1]
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immediately after data collection
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Secondary outcome [1]
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average velocity moment [mm^2/s]
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Assessment method [1]
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The average velocity moment (calculated as as the product of sway velocity path length) will be used to investigate if there is any difference between the test without and with oculomotor task. Statistical tools such t-tests and correlation coefficients will be used to assess if there is a difference between the two tests
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Timepoint [1]
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immediately after data collection
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Secondary outcome [2]
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sway path length [mm]
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Assessment method [2]
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The sway path length (the distance traveled during the test) will be used to investigate if there is any difference between the test without and with oculomotor task. Statistical tools such t-tests and correlation coefficients will be used to assess if there is a difference between the two tests
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Timepoint [2]
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immediately after data collection
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Secondary outcome [3]
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frequency content [Hz]
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Assessment method [3]
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The frequency content (calculated using FFT) will be used to investigate if there is any difference between the test without and with oculomotor task. Statistical tools such t-tests and correlation coefficients will be used to assess if there is a difference between the two tests
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Timepoint [3]
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immediately after data collection
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Eligibility
Key inclusion criteria
* Self assessed healthy subjects
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* subjects suffering from pathology known to affect balance
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/04/2019
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Sample size
Target
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Accrual to date
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Final
150
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Carrick Institute for Graduate Studies - Hampton
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Recruitment postcode(s) [1]
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3188 - Hampton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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Funding & Sponsors
Primary sponsor type
Other
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Name
Carrick Institute for Graduate Studies
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Determine the effects looking in certain direction or moving the eyes in a certain way have on the ability of a subject to maintain equilibrium in different circumstances (eyes open/closed, and standing on hard or compliant surface, with the head straight or rotated right or left, flexed or extended).
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Trial website
https://clinicaltrials.gov/study/NCT02733055
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul Noone, PhD
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Address
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Carrick Institute for Graduate Studies
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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0
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02733055