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Clinical Trials/NCT02733055
NCT02733055
Completed
N/A

Posturography as Biomarker of Oculomotor and Postural Control Integration

Carrick Institute for Graduate Studies1 site in 1 country150 target enrollmentApril 1, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postural Balance
Sponsor
Carrick Institute for Graduate Studies
Enrollment
150
Locations
1
Primary Endpoint
Stability Score
Status
Completed
Last Updated
5 years ago

Overview

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).

Detailed Description

Subjects will undergo computerized dynamic posturography (CDP) testing using the extended modified Clinical Testing of Sensory Integration in Balance (ext_mCTSIB) protocol: the subjects will be required to stand on a hard or the compliant surface in a comfortable posture, feet shoulder width, with eyes open or closed, arms to the side and free to move, gazing forward, and breathing normally, with head straight, turned right or left, flexed or extended. This testing will be used to determine the health status of the subjects. Then a sequence of tests will be performed (they could be done in different days to avoid fatiguing the subject): each sequence will comprise of a baseline test in one of the ext_mCTSIB testing conditions and a subsequent test in the same conditions but with an oculomotor additional task, such as gazing in a specific direction other than straight, performing saccades in different directions, at different speed and using different paradigms (prosaccades, antisaccades, to a remembered target, gap saccades, ...), following a target moving on the screen at different speed and in different directions, receiving an optokinetic stimulation in different directions and at different speeds. Video recordings of the eyes movement may be done to make sure that the subject is actually moving the eyes, to verify that the observers are well trained to detect and count the saccadic movements, as well as to obtain quantitative information regarding the eye movements per se.

Registry
clinicaltrials.gov
Start Date
April 1, 2016
End Date
April 12, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Carrick Institute for Graduate Studies
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Self assessed healthy subjects

Exclusion Criteria

  • subjects suffering from pathology known to affect balance

Outcomes

Primary Outcomes

Stability Score

Time Frame: immediately after data collection

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

Secondary Outcomes

  • sway path length [mm](immediately after data collection)
  • frequency content [Hz](immediately after data collection)
  • average velocity moment [mm^2/s](immediately after data collection)

Study Sites (1)

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