Postural BalanceNCT05649566
Intervention of Virtual Reality on Oculomotor Muscles and Balance
A study testing Virtual Reality game in people with Postural Balance, run by Escoles Universitaries Gimbernat at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Balance
- What is being tested?
- Virtual Reality game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Taking medication that affects the nervous and/or motor system.
- Smoking, alcoholism, taking illicit drugs or neurologically active medications.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Escoles Universitaries Gimbernat
Sant Cugat del Vallès, Barcelona, 08174
About this study
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.
Read the 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.
- Conditions
- Postural Balance
- Being tested
- Virtual Reality game
- Keywords
- Postural Balance, Oculomotor Muscles, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality gameDevice
Also called Beat Saber on Oculus Quest 2 glasses
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Game Group | Experimental | 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. Receives: Device: Virtual Reality game |
| Control Group | No intervention | No intervention during 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Centre Of Pressure at 7 days after 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.
Measured: Day 1 and 7 days after the 12th session.
Secondary outcomes (1)
Change from Baseline PPC at 7 days after 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.
Measured: Day 1 and 7 days after the 12th session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A clinical trial is proposed with young men and women between 18 and 25 years old and physically active (targeted with the International Physical Activity Questionnaire, IPAQ).
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escoles Universitaries Gimbernat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio Gomez Doctor, PT, MsC, Principal investigator, E.U. Gimbernat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649566
- Sponsor's protocol ID
- VRoculomotor
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Winter, D.A., Human balance and posture control during standing and walking. Gait & Posture, 1995. 3(4): 193-214.
León-Molina, P., et al., Center of plantar pressure and postural balance depending on the skull preposition. Rev Fac Odontol Univ Antioq 2016. 28(1): 112-122.
Alexander NB, Galecki AT, Nyquist LV, Hofmeyer MR, Grunawalt JC, Grenier ML, Medell JL. Chair and bed rise performance in ADL-impaired congregate housing residents. J Am Geriatr Soc. 2000 May;48(5):526-33. doi: 10.1111/j.1532-5415.2000.tb04999.x.
PubMed 10811546Cheng PT, Wu SH, Liaw MY, Wong AM, Tang FT. Symmetrical body-weight distribution training in stroke patients and its effect on fall prevention. Arch Phys Med Rehabil. 2001 Dec;82(12):1650-4. doi: 10.1053/apmr.2001.26256.
PubMed 11733877Brandt T, Krafczyk S, Malsbenden I. Postural imbalance with head extension: improvement by training as a model for ataxia therapy. Ann N Y Acad Sci. 1981;374:636-49. doi: 10.1111/j.1749-6632.1981.tb30907.x.
PubMed 6978651Jackson RT, Epstein CM. Effect of head extension on equilibrium in normal subjects. Ann Otol Rhinol Laryngol. 1991 Jan;100(1):63-7. doi: 10.1177/000348949110000110.
PubMed 1985528Paulus WM, Straube A, Brandt T. Visual stabilization of posture. Physiological stimulus characteristics and clinical aspects. Brain. 1984 Dec;107 ( Pt 4):1143-63. doi: 10.1093/brain/107.4.1143.
PubMed 6509312Pinsault N, Vuillerme N. Differential postural effects of plantar-flexor muscle fatigue under normal, altered and improved vestibular and neck somatosensory conditions. Exp Brain Res. 2008 Oct;191(1):99-107. doi: 10.1007/s00221-008-1500-z. Epub 2008 Jul 29.
PubMed 18663436Blanchet M, Prince F, Messier J. Development of postural stability limits: Anteroposterior and mediolateral postural adjustment mechanisms do not follow the same maturation process. Hum Mov Sci. 2019 Feb;63:164-171. doi: 10.1016/j.humov.2018.11.016. Epub 2018 Dec 14.
PubMed 30557794Whitney SL, Roche JL, Marchetti GF, Lin CC, Steed DP, Furman GR, Musolino MC, Redfern MS. A comparison of accelerometry and center of pressure measures during computerized dynamic posturography: a measure of balance. Gait Posture. 2011 Apr;33(4):594-9. doi: 10.1016/j.gaitpost.2011.01.015. Epub 2011 Feb 17.
PubMed 21333541Winter, David A. Review Article: Human balance and posture control during standing and walking. Gait and posture, 1995. 3: p 193-214
Chandler JM, Duncan PW, Studenski SA. Balance performance on the postural stress test: comparison of young adults, healthy elderly, and fallers. Phys Ther. 1990 Jul;70(7):410-5. doi: 10.1093/ptj/70.7.410.
PubMed 2192373Sofianidis G, Dimitriou AM, Hatzitaki V. A Comparative Study of the Effects of Pilates and Latin Dance on Static and Dynamic Balance in Older Adults. J Aging Phys Act. 2017 Jul;25(3):412-419. doi: 10.1123/japa.2016-0164. Epub 2017 Jun 28.
PubMed 27992251Mestre C, Bedell HE, Diaz-Douton F, Pujol J, Gautier J. Characteristics of saccades during the near point of convergence test. Vision Res. 2021 Oct;187:27-40. doi: 10.1016/j.visres.2021.06.001. Epub 2021 Jun 17.
PubMed 34147850Erhardsson M, Alt Murphy M, Sunnerhagen KS. Commercial head-mounted display virtual reality for upper extremity rehabilitation in chronic stroke: a single-case design study. J Neuroeng Rehabil. 2020 Nov 23;17(1):154. doi: 10.1186/s12984-020-00788-x.
PubMed 33228710
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention of Virtual Reality on Oculomotor Muscles and Balance
- ClinicalTrials.gov ID
- NCT05649566
- Acronym / sponsor ID
- VRoculomotor
- Conditions
- Postural Balance
- Keywords
- Postural Balance, Oculomotor Muscles, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Escoles Universitaries GimbernatUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A clinical trial is proposed with young men and women between 18 and 25 years old and physically active (targeted with the International Physical Activity Questionnaire, IPAQ).
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Game Group | Experimental | Device: Virtual Reality gameA 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. |
| Control Group | No intervention | –No intervention during 12 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Taking medication that affects the nervous and/or motor system.
- Smoking, alcoholism, taking illicit drugs or neurologically active medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality gameAlso: Beat Saber on Oculus Quest 2 glassesThe 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 Group |
Primary outcome
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.
1 secondary outcome
Change from Baseline PPC at 7 days after 12th session
Time frame: Day 1 and 7 days after the 12th session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- BackgroundWinter, D.A., Human balance and posture control during standing and walking. Gait & Posture, 1995. 3(4): 193-214.
- BackgroundLeón-Molina, P., et al., Center of plantar pressure and postural balance depending on the skull preposition. Rev Fac Odontol Univ Antioq 2016. 28(1): 112-122.
- Background: PubMed 10811546Alexander NB, Galecki AT, Nyquist LV, Hofmeyer MR, Grunawalt JC, Grenier ML, Medell JL. Chair and bed rise performance in ADL-impaired congregate housing residents. J Am Geriatr Soc. 2000 May;48(5):526-33. doi: 10.1111/j.1532-5415.2000.tb04999.x.
- Background: PubMed 11733877Cheng PT, Wu SH, Liaw MY, Wong AM, Tang FT. Symmetrical body-weight distribution training in stroke patients and its effect on fall prevention. Arch Phys Med Rehabil. 2001 Dec;82(12):1650-4. doi: 10.1053/apmr.2001.26256.
- Background: PubMed 6978651Brandt T, Krafczyk S, Malsbenden I. Postural imbalance with head extension: improvement by training as a model for ataxia therapy. Ann N Y Acad Sci. 1981;374:636-49. doi: 10.1111/j.1749-6632.1981.tb30907.x.
- Background: PubMed 1985528Jackson RT, Epstein CM. Effect of head extension on equilibrium in normal subjects. Ann Otol Rhinol Laryngol. 1991 Jan;100(1):63-7. doi: 10.1177/000348949110000110.
- Background: PubMed 6509312Paulus WM, Straube A, Brandt T. Visual stabilization of posture. Physiological stimulus characteristics and clinical aspects. Brain. 1984 Dec;107 ( Pt 4):1143-63. doi: 10.1093/brain/107.4.1143.
- Background: PubMed 18663436Pinsault N, Vuillerme N. Differential postural effects of plantar-flexor muscle fatigue under normal, altered and improved vestibular and neck somatosensory conditions. Exp Brain Res. 2008 Oct;191(1):99-107. doi: 10.1007/s00221-008-1500-z. Epub 2008 Jul 29.
- Background: PubMed 30557794Blanchet M, Prince F, Messier J. Development of postural stability limits: Anteroposterior and mediolateral postural adjustment mechanisms do not follow the same maturation process. Hum Mov Sci. 2019 Feb;63:164-171. doi: 10.1016/j.humov.2018.11.016. Epub 2018 Dec 14.
- Background: PubMed 21333541Whitney SL, Roche JL, Marchetti GF, Lin CC, Steed DP, Furman GR, Musolino MC, Redfern MS. A comparison of accelerometry and center of pressure measures during computerized dynamic posturography: a measure of balance. Gait Posture. 2011 Apr;33(4):594-9. doi: 10.1016/j.gaitpost.2011.01.015. Epub 2011 Feb 17.
- BackgroundWinter, David A. Review Article: Human balance and posture control during standing and walking. Gait and posture, 1995. 3: p 193-214
- Background: PubMed 2192373Chandler JM, Duncan PW, Studenski SA. Balance performance on the postural stress test: comparison of young adults, healthy elderly, and fallers. Phys Ther. 1990 Jul;70(7):410-5. doi: 10.1093/ptj/70.7.410.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Gomez Doctor, PT, MsC principal investigator
E.U. Gimbernat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality game in people with Postural Balance, run by Escoles Universitaries Gimbernat at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Centre Of Pressure at 7 days after 12th session (time frame: Day 1 and 7 days after the 12th session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649566, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.