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CompletedNCT04574726EQUIVIRTUpdated Jan 22, 2021

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

An interventional study of static balance and dynamic balance in Healthy, sponsored by Pôle Saint Hélier. Completed at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by Pôle Saint Hélier · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Pôle Saint Hélier is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteer, men and women over 18 years old

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    virtual environment

    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.

    Other: static balance · Other: dynamic balance

  • Active comparator
    reel environment

    Balance test in real environment with a motion capture software and a Kinect Azure DK camera.

    Other: static balance · Other: dynamic balance

Interventions

  • Otherstatic balance

    30-second right and left unipodal static balance test

  • Otherdynamic balance

    for the unipodal dynamic balance test, 4 movements will be done by the volunteers in this order : * 180° elevation of the arms * lowering of the arms on the side of the single-legged support to the horizontal position * 180° horizontal translation of the arms * return from the horizontal to the starting point

06

What researchers measure

Primary outcomes

  1. Area of CoP (Center of pression)

    Mesure of area of center of pression during the balance tests in virtual condition and real condition, order in terms of randomisation

    Time frame: Immediately after inclusion

Secondary outcomes

  1. Total distance covered by the CoP during the balance test (in mm)

    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

    Time frame: Immediately after inclusion

  2. Simulator Sickness Quantifying (SSQ)

    SSQ completed after the balance test, SSQ is a scale of cyber sickness, from 0 to 48.

    Time frame: Immediately after the balance test

07

Study locations

2 sites
  • Pole Saint-Hélier
    Rennes, Bretagne 35000, France
  • Hôpital la Musse
    Saint-Sébastien-de-Morsent, 27180, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04574726
Lead sponsor
Pôle Saint Hélier
Collaborators
Hopital La Musse
Responsible party
Sponsor
First posted
Oct 5, 2020
Start date
Nov 16, 2020
Primary completion
Jan 20, 2021
Completion
Jan 20, 2021
Last update
Jan 22, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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