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

NCT04574726 | Completed

• 1 other identifier: 2020-A01841-38
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy

Outcome Measures

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

  Immediately after inclusion

Secondary Outcomes (2)

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

  Immediately after inclusion

• Simulator Sickness Quantifying (SSQ)

  Immediately after the balance test

Study Arms (2)

virtual environment

EXPERIMENTAL

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

reel environment

ACTIVE COMPARATOR

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

Other: static balance; Other: dynamic balance

Interventions

static balance OTHER

30-second right and left unipodal static balance test

reel environment; virtual environment

dynamic balance OTHER

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

reel environment; virtual environment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 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

Sponsors & Collaborators

• Pôle Saint Hélier: lead
• Hopital La Musse: collaborator

Study Sites (2)

Pole 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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, controlled, randomized, intervention study with minimal risks and constraints (RIPH2) on healthy volunteers.

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: November 16, 2020
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

FR (2)