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Posturography as Biomarker of Oculomotor and Postural Control Integration

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ClinicalTrials.gov Identifier: NCT02733055
Recruitment Status : Enrolling by invitation
First Posted : April 11, 2016
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Carrick Institute for Graduate Studies

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).

Condition or disease Intervention/treatment Phase
Postural Balance Other: posturographic evaluation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Posturography as Biomarker of Oculomotor and Postural Control Integration
Study Start Date : April 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: subjects
participant undergoing posturographic evaluation
Other: posturographic evaluation
subjects will undergo CDP testing using one of the ext_mCTSIB tests without (baseline) and with oculomotor task




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. average velocity moment [mm^2/s] [ Time Frame: immediately after data collection ]
    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

  2. sway path length [mm] [ Time Frame: immediately after data collection ]
    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

  3. frequency content [Hz] [ Time Frame: immediately after data collection ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self assessed healthy subjects

Exclusion Criteria:

  • subjects suffering from pathology known to affect balance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733055


Locations
United States, Georgia
Carrick Institute for Graduate Studies
Atlanta, Georgia, United States, 30339
Australia, Victoria
Carrick Institute for Graduate Studies
Hampton, Victoria, Australia, 3188
Sponsors and Collaborators
Carrick Institute for Graduate Studies
Investigators
Principal Investigator: Paul Noone, PhD Carrick Institute for Graduate Studies

Responsible Party: Carrick Institute for Graduate Studies
ClinicalTrials.gov Identifier: NCT02733055     History of Changes
Other Study ID Numbers: CI-IRB-20160321002
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Carrick Institute for Graduate Studies:
Postural Equilibrium
Musculoskeletal Equilibrium
Eye Movements
Saccades
Pursuit, Smooth