Study of Balance Reactions in a Virtual Environment Compared to a Real Environment (EQUIVIRT)

January 20, 2021 updated by: Pôle Saint Hélier
Validate a virtual environment by demonstrating a non modification of the characteristics of postural reaction and displacement of the body's center of pressure between a real environment and the same environment in immersive virtual reality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Sébastien-de-Morsent, France, 27180
        • Hôpital La Musse
    • Bretagne
      • Rennes, Bretagne, France, 35000
        • Pôle Saint-Hélier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteer, men and women over 18 years old

Exclusion Criteria:

  • Severe visual disorders which couldn't enable immersive virtual reality experience
  • Immobilisation of one of the upper limbs (restraint splint)
  • Orthopedic problems and pain in the lower limb
  • MSSQ upper than 25
  • Pregnant women
  • Person under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: virtual environment
Balance test in virtual environment with a virtual reality software executed in a 6DOF Occulus Quest helmet and a motion capture software with a Kinect Azure DK camera.
Other: static balance
30-second right and left unipodal static balance test
Other: dynamic balance

for the unipodal dynamic balance test, 4 movements will be done by the volunteers in this order :

  • 180° elevation of the arms
  • lowering of the arms on the side of the single-legged support to the horizontal position
  • 180° horizontal translation of the arms
  • return from the horizontal to the starting point
Active Comparator: reel environment
Balance test in real environment with a motion capture software and a Kinect Azure DK camera.
Other: static balance
30-second right and left unipodal static balance test
Other: dynamic balance

for the unipodal dynamic balance test, 4 movements will be done by the volunteers in this order :

  • 180° elevation of the arms
  • lowering of the arms on the side of the single-legged support to the horizontal position
  • 180° horizontal translation of the arms
  • return from the horizontal to the starting point

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area of CoP (Center of pression)
Time Frame: Immediately after inclusion
Mesure of area of center of pression during the balance tests in virtual condition and real condition, order in terms of randomisation
Immediately after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total distance covered by the CoP during the balance test (in mm)
Time Frame: Immediately after inclusion
Mesure of the total distance covered by the CoP during the balance tests (in mm) in virtual condition and real condition, order in terms of randomisation
Immediately after inclusion
Simulator Sickness Quantifying (SSQ)
Time Frame: Immediately after the balance test
SSQ completed after the balance test, SSQ is a scale of cyber sickness, from 0 to 48.
Immediately after the balance test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pôle Saint Hélier

Collaborators

Hopital La Musse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Actual)

January 20, 2021

Study Completion (Actual)

January 20, 2021

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-A01841-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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