NCT05235581

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

August 29, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

29 days

First QC Date

January 28, 2022

Last Update Submit

January 16, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Simulator Sickness Quantifying (SSQ)

    Immediately after the balance test

Study Arms (4)

BCAD's arm

EXPERIMENTAL

The 4 interventions are in the BCAD's order.

Other: Intervention A : virtual environment with avatarOther: Intervention B : virtual environment with reinforced visual signalOther: Intervention C : virtual environment with avatar and reinforced visual signalOther: Intervention D : real environment

BACD's arm

EXPERIMENTAL

The 4 interventions are in the BACD's order.

Other: Intervention A : virtual environment with avatarOther: Intervention B : virtual environment with reinforced visual signalOther: Intervention C : virtual environment with avatar and reinforced visual signalOther: Intervention D : real environment

CABD's arm

EXPERIMENTAL

The 4 interventions are in the CABD's order.

Other: Intervention A : virtual environment with avatarOther: Intervention B : virtual environment with reinforced visual signalOther: Intervention C : virtual environment with avatar and reinforced visual signalOther: Intervention D : real environment

ACBD's arm

EXPERIMENTAL

The 4 interventions are in the ACBD's order.

Other: Intervention A : virtual environment with avatarOther: Intervention B : virtual environment with reinforced visual signalOther: Intervention C : virtual environment with avatar and reinforced visual signalOther: Intervention D : real environment

Interventions

Intervention A : virtual environment with avatarOTHER

30-second right and left unipodal static and dynamic balance test with avatar only

ACBD's armBACD's armBCAD's armCABD's arm
Intervention B : virtual environment with reinforced visual signalOTHER

30-second right and left unipodal static and dynamic balance test with reinforced visual signal only

ACBD's armBACD's armBCAD's armCABD's arm
Intervention C : virtual environment with avatar and reinforced visual signalOTHER

30-second right and left unipodal static and dynamic balance test with avatar and reinforced visual signal

ACBD's armBACD's armBCAD's armCABD's arm
Intervention D : real environmentOTHER

30-second right and left unipodal static and dynamic balance test in real environment

ACBD's armBACD's armBCAD's armCABD's arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteer, men and women over 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pôle Saint Hélier

Rennes, Brittany Region, 35000, France

Location

Hôpital la Musse

Saint-Sébastien-de-Morsent, 27180, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Model Details: Prospective, multicenter, controlled, randomized study on healthy volunteers.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 11, 2022

Study Start

August 29, 2022

Primary Completion

September 27, 2022

Study Completion

September 27, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

FR(2)