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

NCT ID: NCT04574726

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2021-01-20

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Prospective, multicenter, controlled, randomized, intervention study with minimal risks and constraints (RIPH2) on healthy volunteers.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

static balance

Intervention Type OTHER

30-second right and left unipodal static balance test

dynamic balance

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

static balance

Intervention Type OTHER

30-second right and left unipodal static balance test

dynamic balance

Intervention Type 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

Interventions

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static balance

30-second right and left unipodal static balance test

Intervention Type OTHER

dynamic 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteer, men and women over 18 years old

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hopital La Musse

OTHER

Sponsor Role collaborator

Pôle Saint Hélier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pole Saint-Hélier

Rennes, Brittany Region, France

Site Status

Hôpital la Musse

Saint-Sébastien-de-Morsent, , France

Site Status

Countries

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France

Other Identifiers

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2020-A01841-38

Identifier Type: -

Identifier Source: org_study_id

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