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

Sponsor

Pôle Saint Hélier (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05235581

Collaborator

Hopital La Musse (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

8.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Prospective, multicenter, controlled, randomized study on healthy volunteers.Prospective, multicenter, controlled, randomized study on healthy volunteers.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Area of CoP (Center of pression) for each test (in cm²) [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
Total distance covered by the CoP during the balance test (in cm) [Immediately after inclusion]
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

Secondary Outcome Measures

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pôle 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:

NCT05235581

Other Study ID Numbers:

2021-A01623-38

First Posted:

Feb 11, 2022

Last Update Posted:

May 3, 2022

Last Verified:

Jan 1, 2022

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

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

Study Results

No Results Posted as of May 3, 2022