Posturography as Biomarker of Oculomotor and Postural Control Integration

NCT ID: NCT02733055

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2019-04-12

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.

Conditions

Postural Balance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

subjects

participant undergoing posturographic evaluation

Group Type: EXPERIMENTAL

posturographic evaluation

Intervention Type: OTHER

subjects will undergo CDP testing using one of the ext\_mCTSIB tests without (baseline) and with oculomotor task

Interventions

posturographic evaluation

subjects will undergo CDP testing using one of the ext\_mCTSIB tests without (baseline) and with oculomotor task

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Self assessed healthy subjects

Exclusion Criteria

• subjects suffering from pathology known to affect balance

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carrick Institute for Graduate Studies

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Noone, PhD

Role: PRINCIPAL_INVESTIGATOR

Carrick Institute for Graduate Studies

Locations

Carrick Institute for Graduate Studies

Atlanta, Georgia, United States

Carrick Institute for Graduate Studies

Hampton, Victoria, Australia

Countries

United States; Australia

Other Identifiers

CI-IRB-20160321002

Identifier Type: -

Identifier Source: org_study_id