Balance Reactions in a Virtual Environment With Avatar and/or Reinforced Visual Signal Compared to a Real Environment (EQUIVIRT2)

Study of the Postural Reactions of Balance Compared Between Real Environment and Virtual Environment With Avatar and Reinforced Visual Signal.

The scientific literature shows that there is a degradation of balance in virtual reality. This trial investigates the introduction of a full-body avatar and/or enhanced visual cues on the reduction of the degradation.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Intervention A : virtual environment with avatar; Other: Intervention B : virtual environment with reinforced visual signal; Other: Intervention C : virtual environment with avatar and reinforced visual signal; Other: Intervention D : real environment

• Study Type: Interventional
• Enrollment (Actual): 74
• 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 deficiency not allowing an activity in immersive virtual reality.
• Immobilization of one of the upper limbs (splint restraint splint)
• Orthopedic and painful problems of the inferior limb
• MSSQ greater than 25
• Pregnant woman
• Person under legal protection

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BCAD's arm; The 4 interventions are in the BCAD's order.	Other: Intervention A : virtual environment with avatar; 30-second right and left unipodal static and dynamic balance test with avatar only; Other: Intervention B : virtual environment with reinforced visual signal; 30-second right and left unipodal static and dynamic balance test with reinforced visual signal only; Other: Intervention C : virtual environment with avatar and reinforced visual signal; 30-second right and left unipodal static and dynamic balance test with avatar and reinforced visual signal; Other: Intervention D : real environment; 30-second right and left unipodal static and dynamic balance test in real environment
Experimental: BACD's arm; The 4 interventions are in the BACD's order.	Other: Intervention A : virtual environment with avatar; 30-second right and left unipodal static and dynamic balance test with avatar only; Other: Intervention B : virtual environment with reinforced visual signal; 30-second right and left unipodal static and dynamic balance test with reinforced visual signal only; Other: Intervention C : virtual environment with avatar and reinforced visual signal; 30-second right and left unipodal static and dynamic balance test with avatar and reinforced visual signal; Other: Intervention D : real environment; 30-second right and left unipodal static and dynamic balance test in real environment
Experimental: CABD's arm; The 4 interventions are in the CABD's order.	Other: Intervention A : virtual environment with avatar; 30-second right and left unipodal static and dynamic balance test with avatar only; Other: Intervention B : virtual environment with reinforced visual signal; 30-second right and left unipodal static and dynamic balance test with reinforced visual signal only; Other: Intervention C : virtual environment with avatar and reinforced visual signal; 30-second right and left unipodal static and dynamic balance test with avatar and reinforced visual signal; Other: Intervention D : real environment; 30-second right and left unipodal static and dynamic balance test in real environment
Experimental: ACBD's arm; The 4 interventions are in the ACBD's order.	Other: Intervention A : virtual environment with avatar; 30-second right and left unipodal static and dynamic balance test with avatar only; Other: Intervention B : virtual environment with reinforced visual signal; 30-second right and left unipodal static and dynamic balance test with reinforced visual signal only; Other: Intervention C : virtual environment with avatar and reinforced visual signal; 30-second right and left unipodal static and dynamic balance test with avatar and reinforced visual signal; Other: Intervention D : real environment; 30-second right and left unipodal static and dynamic balance test in real environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area of CoP (Center of pression) for each test (in cm²)	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
Total distance covered by the CoP during the balance test (in cm)	Mesure of the total distance covered by the CoP during the balance tests (in cm) in virtual condition and real condition, order in terms of randomisation	Immediately after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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): August 29, 2022
• Primary Completion (Actual): September 27, 2022
• Study Completion (Actual): September 27, 2022

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021-A01623-38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No