Posturography as Biomarker of Oculomotor and Postural Control Integration

Postural Balance Clinical Trial

Official title:

Posturography as Biomarker of Oculomotor and Postural Control Integration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733055
• Other study ID #: CI-IRB-20160321002
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: April 12, 2019

Study information

• Verified date: January 2021
• Source: Carrick Institute for Graduate Studies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self assessed healthy subjects

Exclusion Criteria:

• subjects suffering from pathology known to affect balance

Related Conditions & MeSH terms

• Postural Balance

Intervention

Other:
• posturographic evaluation
subjects will undergo CDP testing using one of the ext_mCTSIB tests without (baseline) and with oculomotor task

Locations

Country	Name	City	State
Australia	Carrick Institute for Graduate Studies	Hampton	Victoria
United States	Carrick Institute for Graduate Studies	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Carrick Institute for Graduate Studies

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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