Intervention of Virtual Reality on Oculomotor Muscles and Balance

December 11, 2022 updated by: Escoles Universitaries Gimbernat

Prospective, controlled, randomized, non-masked longitudinal research project for the realization of a doctoral thesis, based on an intervention with virtual reality in order to assess whether the influence on balance and the oculomotor muscles is positive.

The introduction of new technologies in the field of medicine in all fields, and in particular the rehabilitation is fully in place and under development. There are numerous examples like these technologies, including virtual reality (VR), have helped different health fields such as surgery or physiotherapy.

The main aim of the study is to analyze these factors and analyze the way in which virtual reality (VR) can modulate the convergence of the gaze and can influence the center of pressure (COP). As secondary objectives es proposes to analyze the interrelationship between the VR and the COP to analyze the clinical possibilities of application in the field of rehabilitation, whether due to a downward (oculomotor) or upward alteration (COP alteration), as well as if physical activity or gender can also influence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The center of pressure (COP) is the point where the resultant of the ground reaction forces is applied to the base of support. The oscillation of the individual with respect to the ground is projected in an anteroposterior line (AP) and another mediolateral (ML). With these two parameters you can define the total route covered by the COP. The population general presents a small area: parameters of short distance and fast and precise displacements. An alteration of the balance can be objectified by measuring an increase in the same area; reflecting a loss of axis control AP and ML and a slowing in the perception of this loss.

The oculomotor muscles are responsible for maintaining horizontal gaze; given the position bipedal, the brain seeks to maintain this premise to allow carrying out the usual activities in it position A good response of this musculature, specifically, the ability to accommodate the convergence of the look, will guarantee optimal function.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sant Cugat Del Vallès, Barcelona, Spain, 08174
        • Escoles Universitaries Gimbernat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 23 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 25 years old.
  • No visual alteration.
  • No history of vertigo.
  • No pathology that compromises balance.
  • Physically active (where the first two questions are affirmative and are 3 days and 3 hours, respectively.

Exclusion Criteria:

  • Taking medication that affects the nervous and/or motor system.
  • Smoking, alcoholism, taking illicit drugs or neurologically active medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Game Group
A total of 24 interventions will be carried out for each participant, separated by 2 each week for 3 months. Each intervention will consist of a VR session lasting 30 minutes. Each participant must play for 30 minutes in the game "Beat know". The game consists of cutting mobile targets, using lightsabers while avoiding obstacles that approach the user. This game is a reference for immersive play since, while distracting, it recreates a physical activity similar to what would be done in reality. It has been shown that the same energy expenditure, on the part of the user, practicing tennis in real life, is what he does playing "Beat Saber" playing the same period of time.
Device: Virtual Reality game
The game consists of cutting mobile targets, using lightsabers while avoiding obstacles that approach the user. This game is a reference for immersive play since, while distracting, it recreates a physical activity similar to what would be done in reality. It has been shown that the same energy expenditure, on the part of the user, practicing tennis in real life, is what he does playing "Beat Saber" playing the same period of time.
Other Names:
  • Beat Saber on Oculus Quest 2 glasses
No Intervention: Control Group
No intervention during 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Centre Of Pressure at 7 days after 12th session
Time Frame: Day 1 and 7 days after the 12th session.
The pressure center (COP) is the point where the resulting reaction forces with the ground is applied to the support base. The oscillation of the individual with respect to the ground is projected in an anteroposterior line (AP) and a mediolateral line (ML). With these two parameters, the total route covered by the COP can be defined. An alteration of balance can be objectified by measuring an increase in the same area; reflecting a loss of control of the AP and ML axes and a slowdown in the perception of this loss.
Day 1 and 7 days after the 12th session.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline PPC at 7 days after 12th session
Time Frame: Day 1 and 7 days after the 12th session.
The Near Convergence Point (PPC) test analyzes the effectiveness of the oculomotor muscles, consists of showing a stimulus 40 centimeters from the participant, a point where the vision of this stimulus should not be double. The stimulus will approach until the participant sees double, it is the breaking point and it will be the PPC to be measured.
Day 1 and 7 days after the 12th session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escoles Universitaries Gimbernat

Investigators

  • Principal Investigator: Sergio Gomez Doctor, PT, MsC, E.U. Gimbernat

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

December 11, 2022

First Posted (Estimate)

December 14, 2022

Study Record Updates

Last Update Posted (Estimate)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 11, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VRoculomotor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postural Balance

Clinical Trials on Virtual Reality game

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe