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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: static balance; Other: dynamic balance

• Registration Number: NCT04574726
• Lead Sponsor: Pôle Saint Hélier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-05
• Study Start: 2020-11-16
• Status Verified: 2021-01
• Primary Completion: 2021-01-20
• Study Completion: 2021-01-20
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
reel environment	static balance	Balance test in real environment with a motion capture software and a Kinect Azure DK camera.
reel environment	dynamic balance	Balance test in real environment with a motion capture software and a Kinect Azure DK camera.
virtual environment	static balance	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.
virtual environment	dynamic balance	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Hôpital la Musse; 🇫🇷 Saint-Sébastien-de-Morsent, France

Pole Saint-Hélier; 🇫🇷 Rennes, Bretagne, France