HealthyEQUIVIRT2NCT05235581
Balance Reactions in a Virtual Environment With Avatar and/or Reinforced Visual Signal Compared to a Real Environment
A study testing Intervention A : virtual environment with avatar, Intervention B : virtual environment with reinforced visual signal and Intervention C : virtual environment with avatar and reinforced visual signal in people with Healthy, run by Pôle Saint Hélier at 2 sites in France.
Trial summary
The scientific literature shows that there is a degradation of balance in virtual reality. This trial investigates the introduction of a full-body avatar and/or enhanced visual cues on the reduction of the degradation. 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?
- Intervention A : virtual environment with avatar, Intervention B : virtual environment with reinforced visual signal and Intervention C : virtual environment with avatar and reinforced visual signal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Aug 2022to 27 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 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 deficiency not allowing an activity in immersive virtual reality.
- Immobilization of one of the upper limbs (splint restraint splint)
- Orthopedic and painful problems of the inferior limb
- MSSQ greater than 25
- Pregnant woman
- Person under legal protection
Trial locations and contacts
2 sites in 1 country.
France2 sites
Pôle Saint Hélier
Rennes, Brittany Region, 35000
Hôpital la Musse
Saint-Sébastien-de-Morsent, 27180
About this study
Official title: Study of the Postural Reactions of Balance Compared Between Real Environment and Virtual Environment With Avatar and Reinforced Visual Signal.
The scientific literature shows that there is a degradation of balance in virtual reality. This trial investigates the introduction of a full-body avatar and/or enhanced visual cues on the reduction of the degradation.
- Conditions
- Healthy
- Being tested
- Intervention A : virtual environment with avatar, Intervention B : virtual environment with reinforced visual signal, Intervention C : virtual environment with avatar and reinforced visual signal, Intervention D : real environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention A : virtual environment with avatarOther
30-second right and left unipodal static and dynamic balance test with avatar only
Intervention B : virtual environment with reinforced visual signalOther
30-second right and left unipodal static and dynamic balance test with reinforced visual signal only
Intervention C : virtual environment with avatar and reinforced visual signalOther
30-second right and left unipodal static and dynamic balance test with avatar and reinforced visual signal
Intervention D : real environmentOther
30-second right and left unipodal static and dynamic balance test in real environment
| Study group | Role | What they receive |
|---|---|---|
| BCAD's arm | Experimental | The 4 interventions are in the BCAD's order. Receives: Other: Intervention A : virtual environment with avatar; Other: Intervention B : virtual environment with reinforced visual signal; Other: Intervention C : virtual environment with avatar and reinforced visual signal; Other: Intervention D : real environment |
| BACD's arm | Experimental | The 4 interventions are in the BACD's order. Receives: Other: Intervention A : virtual environment with avatar; Other: Intervention B : virtual environment with reinforced visual signal; Other: Intervention C : virtual environment with avatar and reinforced visual signal; Other: Intervention D : real environment |
| CABD's arm | Experimental | The 4 interventions are in the CABD's order. Receives: Other: Intervention A : virtual environment with avatar; Other: Intervention B : virtual environment with reinforced visual signal; Other: Intervention C : virtual environment with avatar and reinforced visual signal; Other: Intervention D : real environment |
| ACBD's arm | Experimental | The 4 interventions are in the ACBD's order. Receives: Other: Intervention A : virtual environment with avatar; Other: Intervention B : virtual environment with reinforced visual signal; Other: Intervention C : virtual environment with avatar and reinforced visual signal; Other: Intervention D : real environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of CoP (Center of pression) for each test (in cm²)
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
Total distance covered by the CoP during the balance test (in cm)
Mesure of the total distance covered by the CoP during the balance tests (in cm) in virtual condition and real condition, order in terms of randomisation
Measured: Immediately after inclusion
Secondary outcomes (1)
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 posted11 Feb 2022
- Study start29 Aug 2022
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
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
- Sequential
- Model description
- Prospective, multicenter, controlled, randomized study on healthy volunteers.
- Masking
- None (open label)
- Enrolment
- 74 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
- NCT05235581
- Sponsor's protocol ID
- 2021-A01623-38
- Acronym
- EQUIVIRT2
- Status last verified
- Jan 2023
- First submitted
- 28 Jan 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Postural Reactions of Balance Compared Between Real Environment and Virtual Environment With Avatar and Reinforced Visual Signal.
- ClinicalTrials.gov ID
- NCT05235581
- Acronym / sponsor ID
- EQUIVIRT2 / 2021-A01623-38
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Collaborators
- Hopital La Musse
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 11 Feb 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.
The scientific literature shows that there is a degradation of balance in virtual reality. This trial investigates the introduction of a full-body avatar and/or enhanced visual cues on the reduction of the degradation.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective, multicenter, controlled, randomized study on healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| BCAD's arm | Experimental | Other: Intervention A : virtual environment with avatar, Other: Intervention B : virtual environment with reinforced visual signal, Other: Intervention C : virtual environment with avatar and reinforced visual signal, Other: Intervention D : real environmentThe 4 interventions are in the BCAD's order. |
| BACD's arm | Experimental | Other: Intervention A : virtual environment with avatar, Other: Intervention B : virtual environment with reinforced visual signal, Other: Intervention C : virtual environment with avatar and reinforced visual signal, Other: Intervention D : real environmentThe 4 interventions are in the BACD's order. |
| CABD's arm | Experimental | Other: Intervention A : virtual environment with avatar, Other: Intervention B : virtual environment with reinforced visual signal, Other: Intervention C : virtual environment with avatar and reinforced visual signal, Other: Intervention D : real environmentThe 4 interventions are in the CABD's order. |
| ACBD's arm | Experimental | Other: Intervention A : virtual environment with avatar, Other: Intervention B : virtual environment with reinforced visual signal, Other: Intervention C : virtual environment with avatar and reinforced visual signal, Other: Intervention D : real environmentThe 4 interventions are in the ACBD's order. |
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 deficiency not allowing an activity in immersive virtual reality.
- Immobilization of one of the upper limbs (splint restraint splint)
- Orthopedic and painful problems of the inferior limb
- MSSQ greater than 25
- Pregnant woman
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 |
|---|---|---|
| Intervention A : virtual environment with avatar30-second right and left unipodal static and dynamic balance test with avatar only | Other | ACBD's arm, BACD's arm, BCAD's arm, CABD's arm |
| Intervention B : virtual environment with reinforced visual signal30-second right and left unipodal static and dynamic balance test with reinforced visual signal only | Other | ACBD's arm, BACD's arm, BCAD's arm, CABD's arm |
| Intervention C : virtual environment with avatar and reinforced visual signal30-second right and left unipodal static and dynamic balance test with avatar and reinforced visual signal | Other | ACBD's arm, BACD's arm, BCAD's arm, CABD's arm |
| Intervention D : real environment30-second right and left unipodal static and dynamic balance test in real environment | Other | ACBD's arm, BACD's arm, BCAD's arm, CABD's arm |
Primary outcome
Area of CoP (Center of pression) for each test (in cm²)
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
Total distance covered by the CoP during the balance test (in cm)
Time frame: Immediately after inclusion
Mesure of the total distance covered by the CoP during the balance tests (in cm) in virtual condition and real condition, order in terms of randomisation
1 secondary outcome
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 18 Jan 2023.
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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 Intervention A : virtual environment with avatar, Intervention B : virtual environment with reinforced visual signal and Intervention C : virtual environment with avatar and reinforced visual signal 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 18 Jan 2023. 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) for each test (in cm²) (time frame: Immediately after inclusion). The study lists 2 primary outcomes in all. 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 18 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.