HealthyEQUIVIRTNCT04574726
Study of Balance Reactions in a Virtual Environment Compared to a Real Environment
A study testing static balance and dynamic balance in people with Healthy, run by Pôle Saint Hélier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- static balance and dynamic balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Nov 2020to 20 Jan 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer, men and women over 18 years old
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Pole Saint-Hélier
Rennes, Brittany Region, 35000
Hôpital la Musse
Saint-Sébastien-de-Morsent, 27180
About this study
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
- Being tested
- static balance, dynamic balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
static balanceOther
30-second right and left unipodal static balance test
dynamic balanceOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: static balance; Other: dynamic balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after inclusion
Secondary outcomes (2)
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
Measured: Immediately after inclusion
Simulator Sickness Quantifying (SSQ)
SSQ completed after the balance test, SSQ is a scale of cyber sickness, from 0 to 48.
Measured: Immediately after the balance test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start16 Nov 2020
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, multicenter, controlled, randomized, intervention study with minimal risks and constraints (RIPH2) on healthy volunteers.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital La Musse
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574726
- Sponsor's protocol ID
- 2020-A01841-38
- Acronym
- EQUIVIRT
- Status last verified
- Jan 2021
- First submitted
- 28 Sep 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Balance Reactions in a Virtual Environment Compared to a Real Environment
- ClinicalTrials.gov ID
- NCT04574726
- Acronym / sponsor ID
- EQUIVIRT / 2020-A01841-38
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Collaborators
- Hopital La Musse
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 5 Oct 2020 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, controlled, randomized, intervention study with minimal risks and constraints (RIPH2) on healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| virtual environment | Experimental | Other: static balance, Other: dynamic balanceBalance 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. |
| reel environment | Active comparator | Other: static balance, Other: dynamic balanceBalance test in real environment with a motion capture software and a Kinect Azure DK camera. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteer, men and women over 18 years old
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| static balance30-second right and left unipodal static balance test | Other | reel environment, virtual environment |
| dynamic balancefor 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 | Other | reel environment, virtual environment |
Primary outcome
Area of CoP (Center of pression)
Time frame: Immediately after inclusion
Mesure of area of center of pression during the balance tests in virtual condition and real condition, order in terms of randomisation
2 secondary outcomes
Total distance covered by the CoP during the balance test (in mm)
Time frame: Immediately after inclusion
Simulator Sickness Quantifying (SSQ)
Time frame: Immediately after the balance test
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 22 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing static balance and dynamic balance in people with Healthy, run by Pôle Saint Hélier at 2 sites in France.
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 1 inclusion and 6 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Area of CoP (Center of pression) (time frame: Immediately after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2021.