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

Sponsor

Pôle Saint Hélier (Other)

Overall Status

Completed

CT.gov ID

NCT04574726

Collaborator

Hopital La Musse (Other)

Enrollment

Locations

Arms

2.1

Actual Duration (Months)

Patients Per Site

16.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: static balance Other: dynamic balance	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Prospective, multicenter, controlled, randomized, intervention study with minimal risks and constraints (RIPH2) on healthy volunteers.Prospective, multicenter, controlled, randomized, intervention study with minimal risks and constraints (RIPH2) on healthy volunteers.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Study of Balance Reactions in a Virtual Environment Compared to a Real Environment

Actual Study Start Date :

Nov 16, 2020

Actual Primary Completion Date :

Jan 20, 2021

Actual Study Completion Date :

Jan 20, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Area of CoP (Center of pression) [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

Secondary Outcome Measures

Total distance covered by the CoP during the balance test (in mm) [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
Simulator Sickness Quantifying (SSQ) [Immediately after the balance test]
SSQ completed after the balance test, SSQ is a scale of cyber sickness, from 0 to 48.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pole Saint-Hélier	Rennes	Bretagne	France	35000
2	Hôpital la Musse	Saint-Sébastien-de-Morsent		France	27180

Sponsors and Collaborators

Pôle Saint Hélier
Hopital La Musse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pôle Saint Hélier

ClinicalTrials.gov Identifier:

NCT04574726

Other Study ID Numbers:

2020-A01841-38

First Posted:

Oct 5, 2020

Last Update Posted:

Jan 22, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 22, 2021