Healthy Volunteers3DPICKNCT02563236
Evaluation of 3D Selection Tasks in Parabolic Flight Conditions: Pointing Task in Augmented Reality User Interfaces
A study testing Parabolic flight in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
During a space mission the crew has to perform a wide variety of tasks under different acceleration conditions. For handling of displays and control items during a mission, the astronaut's performance is strong depended on an intuitive usability. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Parabolic flight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Dec 2014
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers (men or women)
- Aged from 21 to 55
- Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
- Who accepted to take part in the study
- Who has already experience in handling specific AR interfaces while wearing an HMD
- Who have given their written stated consent
- Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection.
Who cannot join
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
During a space mission the crew has to perform a wide variety of tasks under different acceleration conditions. For handling of displays and control items during a mission, the astronaut's performance is strong depended on an intuitive usability. Currently investigators are exploring and developing different Augmented Reality interfaces for the International Standard Payload Rack (ISPR) Biolab that is installed in the International Space Station (ISS) module Columbus. Augmented reality (AR) is a live, direct or indirect, view of a physical, real-world environment whose elements are augmented by computer-generated sensory input such as sound, video, graphics or GPS data. Using AR technologies provides user-oriented support for working procedures in development, production, and operating of complex technical products and systems. It is conceivable that in future manned missions such interfaces will be applied to space operations, where the astronaut will handle virtual information that enriches the physical reality. To improve the support for the operational ground team and the space crew by performing service and maintenance tasks at the Columbus space laboratory Biolab, investigators explore innovative tridimensional (3D) interaction techniques that allow an intuitive way to interact with the virtual content. The developed AR interfaces for the ISPR Biolab ought to offer support while handling standardize service and maintenance procedures. This research is primarily focused on supporting the ground team during their work at the engineering model of Biolab that is located in Cologne at the Institute of Aerospace Medicine. Applying these interfaces subsequently to space operations requires previous exploration regarding the influence of different acceleration conditions that ought to be considered at the investigators' current stage of designing and development. Thereby one important aspect is focused on the correct placement of virtual user interfaces while interacting with it. To explore human adaption of handling and controlling virtual AR interfaces, this experiment denotes a usability study that will supply findings about human mental workload and sensorimotor coordination while performing the experimentation task under different accelerations of gravity. The proposed experiment will supply essential information about understanding the adequate quality characteristics concerning placement of virtual interfaces in physical reality and identify disturbing factors while applying in hyper-g and micro-g conditions.
Read the detailed description
Investigations description --------------------------------- Augmented Reality 2 different Head-Mounted-Displays (ARVision3D from Trivisio; dataGlass/2A from Shimadzu), controlled by 2 PC will be used. The first HMD is a monocular optical see-through (OST) HMD: it is equipped with a semi-transparent LCD display for one eye. The user can directly see the physical world without limitations regarding the peripheral field of view. The second HMD is a binocular video see-through (VST) HMD: it is equipped with two LCD displays and a stereo camera system that records the physical environment and replays the video onto the displays in real-time.
Experimental protocol
---------------------------- Before flight subjects will be familiarized with the setup and the protocol. For each flight day, 2 subjects will be studied one for each AR device. Halfway during the flight, the 2 subjects will swap places. The procedure will be the following on all 3 days.
The experiment day will start at 7.30 a.m. with the test subjects equipped with heart rate recording device. After take-off and after work will be permitted, the 2 subjects will go to the experimental area where they will be seated. They will be equipped with one of the HMD (optical- or video-see through HM). During a parabola the subjects perform the experimentation task: symbolic input of five letters onto virtual keyboard depending on the experimental task during a parabola.
To point towards the virtual keyboard the subject wears a thimble on his forefinger. The body-alignment scenario requires an additional panel on subject's non-dominant hand.
During a parabola two subjects perform the tasks - one is using HMD type 1 in hyper-g and the other subject is using HMD type 2 in micro-g.
During the 8 minute rest period between parabolas 15 and 16, the 2 test subjects will switch places. Switching place will be a straightforward process as each member of our team has expertise in manning the test equipment.
- Conditions
- Healthy Volunteers
- Being tested
- Parabolic flight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parabolic flightOther
| Study group | Role | What they receive |
|---|---|---|
| Parabolic flight and Augmented Reality interface alignments | Experimental | Not described Receives: Other: Parabolic flight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gravity induced change in completion time of a pointing task on a virtual keyboard (ms)
Measured: baseline
Gravity induced change in error rate of the pointing task
Measured: baseline
Gravity induced change in accuracy (centimeter) of the pointing task
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563236
- Sponsor's protocol ID
- 12-022
- Acronym
- 3DPICK
- Status last verified
- Sep 2015
- First submitted
- 23 Jul 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D Selection Tasks in Parabolic Flight Conditions: Pointing Task in Augmented Reality User Interfaces
- ClinicalTrials.gov ID
- NCT02563236
- Acronym / sponsor ID
- 3DPICK / 12-022
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Sep 2015 (estimated)
- 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.
During a space mission the crew has to perform a wide variety of tasks under different acceleration conditions. For handling of displays and control items during a mission, the astronaut's performance is strong depended on an intuitive usability. Currently investigators are exploring and developing different Augmented Reality interfaces for the International Standard Payload Rack (ISPR) Biolab that is installed in the International Space Station (ISS) module Columbus. Augmented reality (AR) is a live, direct or indirect, view of a physical, real-world environment whose elements are augmented by computer-generated sensory input such as sound, video, graphics or GPS data. Using AR technologies provides user-oriented support for working procedures in development, production, and operating of complex technical products and systems. It is conceivable that in future manned missions such interfaces will be applied to space operations, where the astronaut will handle virtual information that enriches the physical reality. To improve the support for the operational ground team and the space crew by performing service and maintenance tasks at the Columbus space laboratory Biolab, investigators explore innovative tridimensional (3D) interaction techniques that allow an intuitive way to interact with the virtual content. The developed AR interfaces for the ISPR Biolab ought to offer support while handling standardize service and maintenance procedures. This research is primarily focused on supporting the ground team during their work at the engineering model of Biolab that is located in Cologne at the Institute of Aerospace Medicine. Applying these interfaces subsequently to space operations requires previous exploration regarding the influence of different acceleration conditions that ought to be considered at the investigators' current stage of designing and development. Thereby one important aspect is focused on the correct placement of virtual user interfaces while interacting with it. To explore human adaption of handling and controlling virtual AR interfaces, this experiment denotes a usability study that will supply findings about human mental workload and sensorimotor coordination while performing the experimentation task under different accelerations of gravity. The proposed experiment will supply essential information about understanding the adequate quality characteristics concerning placement of virtual interfaces in physical reality and identify disturbing factors while applying in hyper-g and micro-g conditions.
Detailed description
Investigations description --------------------------------- Augmented Reality 2 different Head-Mounted-Displays (ARVision3D from Trivisio; dataGlass/2A from Shimadzu), controlled by 2 PC will be used. The first HMD is a monocular optical see-through (OST) HMD: it is equipped with a semi-transparent LCD display for one eye. The user can directly see the physical world without limitations regarding the peripheral field of view. The second HMD is a binocular video see-through (VST) HMD: it is equipped with two LCD displays and a stereo camera system that records the physical environment and replays the video onto the displays in real-time.
Experimental protocol
---------------------------- Before flight subjects will be familiarized with the setup and the protocol. For each flight day, 2 subjects will be studied one for each AR device. Halfway during the flight, the 2 subjects will swap places. The procedure will be the following on all 3 days.
The experiment day will start at 7.30 a.m. with the test subjects equipped with heart rate recording device. After take-off and after work will be permitted, the 2 subjects will go to the experimental area where they will be seated. They will be equipped with one of the HMD (optical- or video-see through HM). During a parabola the subjects perform the experimentation task: symbolic input of five letters onto virtual keyboard depending on the experimental task during a parabola.
To point towards the virtual keyboard the subject wears a thimble on his forefinger. The body-alignment scenario requires an additional panel on subject's non-dominant hand.
During a parabola two subjects perform the tasks - one is using HMD type 1 in hyper-g and the other subject is using HMD type 2 in micro-g.
During the 8 minute rest period between parabolas 15 and 16, the 2 test subjects will switch places. Switching place will be a straightforward process as each member of our team has expertise in manning the test equipment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parabolic flight and Augmented Reality interface alignments | Experimental | Other: Parabolic flight |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteers (men or women)
- Aged from 21 to 55
- Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
- Who accepted to take part in the study
- Who has already experience in handling specific AR interfaces while wearing an HMD
Key exclusion criteria (2 listed)
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- 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 |
|---|---|---|
| Parabolic flight | Other | Parabolic flight and Augmented Reality interface alignments |
Primary outcome
Gravity induced change in completion time of a pointing task on a virtual keyboard (ms)
Time frame: baseline
Gravity induced change in error rate of the pointing task
Time frame: baseline
Gravity induced change in accuracy (centimeter) of the pointing task
Time frame: baseline
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 30 Sep 2015.
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Screening Protocol
Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parabolic flight in people with Healthy Volunteers, run by University Hospital, Caen at 1 site 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 7 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 30 Sep 2015. 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 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?
Gravity induced change in completion time of a pointing task on a virtual keyboard (ms) (time frame: baseline). The study lists 3 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 30 Sep 2015.