Posturography as Biomarker of Oculomotor and Postural Control Integration

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).

Study Overview

• Status: Completed
• Conditions: Postural Balance
• Intervention / Treatment: Other: posturographic evaluation

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
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Hampton, Victoria, Australia, 3188
      • Carrick Institute for Graduate Studies
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30339
      • Carrick Institute for Graduate Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Self assessed healthy subjects

Exclusion Criteria:

• subjects suffering from pathology known to affect balance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	immediately after data collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	immediately after data collection
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	immediately after data collection
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	immediately after data collection

Collaborators and Investigators

• Sponsor: Carrick Institute for Graduate Studies
• Investigators: Principal Investigator: Paul Noone, PhD, Carrick Institute for Graduate Studies

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 12, 2019
• Study Completion (Actual): April 12, 2019

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Saccades; Eye Movements; Postural Equilibrium; Musculoskeletal Equilibrium; Pursuit, Smooth
• Other Study ID Numbers: CI-IRB-20160321002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO