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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02733055




Registration number
NCT02733055
Ethics application status
Date submitted
5/04/2016
Date registered
11/04/2016
Date last updated
19/07/2017

Titles & IDs
Public title
Posturography as Biomarker of Oculomotor and Postural Control Integration
Scientific title
Posturography as Biomarker of Oculomotor and Postural Control Integration
Secondary ID [1] 0 0
CI-IRB-20160321002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural Balance 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stability Score - 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
Timepoint [1] 0 0
immediately after data collection
Secondary outcome [1] 0 0
average velocity moment [mm^2/s] - 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
Timepoint [1] 0 0
immediately after data collection
Secondary outcome [2] 0 0
sway path length [mm] - 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
Timepoint [2] 0 0
immediately after data collection
Secondary outcome [3] 0 0
frequency content [Hz] - 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
Timepoint [3] 0 0
immediately after data collection

Eligibility
Key inclusion criteria
- Self assessed healthy subjects
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- subjects suffering from pathology known to affect balance

Study design
Purpose of the study
Basic Science
Allocation to intervention
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)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
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)
VIC
Recruitment hospital [1] 0 0
Carrick Institute for Graduate Studies - Hampton
Recruitment postcode(s) [1] 0 0
3188 - Hampton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia

Funding & Sponsors
Primary sponsor type
Other
Name
Carrick Institute for Graduate Studies
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT02733055
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Noone, PhD
Address 0 0
Carrick Institute for Graduate Studies
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02733055