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NCT05235581 Clinical Trial

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

Healthy Clinical Trial

— EQUIVIRT2  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05235581
Other study ID # 2021-A01623-38
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 29, 2022
Est. completion date September 27, 2022

Study information
Verified date January 2023
Source Pôle Saint Hélier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date September 27, 2022
Est. primary completion date September 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Intervention A : virtual environment with avatar
30-second right and left unipodal static and dynamic balance test with avatar only
• Intervention B : virtual environment with reinforced visual signal
30-second right and left unipodal static and dynamic balance test with reinforced visual signal only
• 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
• Intervention D : real environment
30-second right and left unipodal static and dynamic balance test in real environment

Locations
Country Name City State
France Pôle Saint Hélier Rennes Bretagne
France Hôpital la Musse Saint-Sébastien-de-Morsent

Sponsors (2)
Lead Sponsor Collaborator
Pôle Saint Hélier Hopital La Musse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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