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

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: Healthy
• Intervention / Treatment: Other: static balance; Other: dynamic balance

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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)	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)	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

• Sponsor: Pôle Saint Hélier
• Collaborators: Hopital La Musse

Study record dates

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