NCT02733055

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

April 5, 2016

Last Update Submit

January 25, 2021

Conditions

Postural Balance

Keywords

Postural EquilibriumMusculoskeletal EquilibriumEye MovementsSaccadesPursuit, Smooth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • average velocity moment [mm^2/s]

    immediately after data collection

  • sway path length [mm]

    immediately after data collection

  • frequency content [Hz]

    immediately after data collection

Study Arms (1)

subjects

EXPERIMENTAL

participant undergoing posturographic evaluation

Other: posturographic evaluation

Interventions

posturographic evaluationOTHER

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

subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self assessed healthy subjects

You may not qualify if:

  • subjects suffering from pathology known to affect balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Carrick Institute for Graduate Studies

Atlanta, Georgia, 30339, United States

Location

Carrick Institute for Graduate Studies

Hampton, Victoria, 3188, Australia

Location

Study Officials

  • Paul Noone, PhD

    Carrick Institute for Graduate Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 11, 2016

Study Start

April 1, 2016

Primary Completion

April 12, 2019

Study Completion

April 12, 2019

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)AU(1)