Healthy VolunteersGrafismNCT02563275
The Operation of Control Devices During Parabolic Flights: Influence of Weightlessness, Stress and Motivation
A study testing motion analysis system and parabolic flight in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
The aim of this project is to investigate whether alterations in sensory-motor performances during weightlessness are only of theoretical relevance, or indeed restrict the capacity of the participants. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- motion analysis system and parabolic flight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Oct 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (men or women)
- Aged from 21 to 65
- Right handed
- 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 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
- Person with medical history of neurological disorders
- Person with medical history of musculoskeletal disorders of the lower limbs, especially of the ankle and knee joint.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Umr Ucbn/Inserm U1075 Comete
Caen, Basse-Normandie, 14032
Pierre Denise, MD PhD, 332068214, pierre.denise@unicaen.fr
About this study
The aim of this project is to investigate whether alterations in sensory-motor performances during weightlessness are only of theoretical relevance, or indeed restrict the capacity of the participants. To find out, volunteers will monitor a complex realistic process by operation of buttons and switches in weightlessness. The task will mimic the control of vehicles, research equipment and industrial processes. Effects of weightlessness will be separated from effects induced by stress and those of motivation through evaluation of cortisol and manipulation of motivation.
Read the detailed description
Investigations description
---------------------------------- Subjects will sit in a rack at a table in front of a 17" screen of an Eye Tracker system (Tobii® T60). The right part of the screen will be covered by a row of operating devices; two rotary knobs of different size, one turn switch and one simple push button. The construction of these devices is based on real ones on board the ISS. Integrated in three of these devices are force sensors (6D ATI® Nano17), which register grip torques and forces while subjects' manipulate the devices.
Four Vicon® Bonita cameras are positioned over the table and attached to a table-fixed metal frame. They will register hand dynamics throughout all grasping movements in normal gravity as well as in microgravity.
In accordance to a classical control task by Kramer (1999) subjects will be asked to control pointer instruments, which are displayed one below the other on the screen. These controls will be embedded in a real life scenario where subjects have to react on specific signals within this scenario: As soon as one of the displayed pointers reach a critical deflection, subjects have to react as fast as possible by grasping towards the associated control device, rotate or push it and turn back to the starting position. This action will bring the pointers back to an uncritical position. The pointers will move independent from the others. Additionally we introduce one compatible and one incompatible pointer-device connection, i.e. the upper pointer can be controlled with the lower device, the middle pointer with the middle and the lower pointer with the upper device.
Equipment used --------------------- Hand movements Hand movements are registered from above and the side by four infrared high-speed cameras (Bonita Vicon-Cameras - CE mark 0088) which register with 250Hz the 3D positions of ten small reflexive markers (attached by double sided adhesive tape to all fingertips and to the thumb of the subjects' right hand). The cameras are connected via cables with an Ultranet which is the central processing unit. The Ultranet is connected with a network cable to a corresponding desktop computer.
Force and torque sensors The different knobs (three of them) that have to be grasped, measure forces and torques applied to it at a rate of 250Hz. These sensors (Nano 17 of the ATI DAQ F/T System) are connected to power supply boxes with a booster, which supplies the data via a DAQ card to the desktop computer. We will analyze usual force parameters such as initial forces at the knob, but also maximal forces applied to the knobs.
Experimental protocol
----------------------------- Before flight subjects will be familiarized with the setup and the protocol. For each flight day, only one subject will be studied. The procedure will be the same on each flight.
Overall one subject will be tested during 26 parabolas. Within the first 13 parabolas motivational state will be manipulated in a positive way by means of positive word presentation (subliminal priming) and within the last 13 parabolas with negative words. The order of positive versus negative priming will be counterbalanced across subjects.
All subjects perform the task of operating control devices once in level flight before the first parabolas, during the parabolas and after the parabolas. After the whole flight subjects will perform the control task again.
- Conditions
- Healthy Volunteers
- Being tested
- motion analysis system, parabolic flight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motion analysis systemOther
parabolic flightOther
| Study group | Role | What they receive |
|---|---|---|
| Human fine motor skills measurements during weightlessness | Other | Not described Receives: Other: motion analysis system; Other: parabolic flight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity (deg/sec) of the right hand movement measured with a motion analysis system
Measured: baseline
Forces (Newton) applied by the hand on the objects to be grasped measured with strain gauges
Measured: baseline
Torques (N.m) applied by the hand on the objects to be grasped measured with strain gauges
Measured: baseline
Peak velocity (deg/sec) of the right hand measured with a motin analysis system
Measured: baseline
Initial force (Newton) on the grasped object measured with strain gauges
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 2013
- Primary completionOct 2015 (estimated)
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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563275
- Sponsor's protocol ID
- 13-002
- Acronym
- Grafism
- Status last verified
- Sep 2015
- First submitted
- 22 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
- The Operation of Control Devices During Parabolic Flights: Influence of Weightlessness, Stress and Motivation
- ClinicalTrials.gov ID
- NCT02563275
- Acronym / sponsor ID
- Grafism / 13-002
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2015 (estimated)
- 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.
The aim of this project is to investigate whether alterations in sensory-motor performances during weightlessness are only of theoretical relevance, or indeed restrict the capacity of the participants. To find out, volunteers will monitor a complex realistic process by operation of buttons and switches in weightlessness. The task will mimic the control of vehicles, research equipment and industrial processes. Effects of weightlessness will be separated from effects induced by stress and those of motivation through evaluation of cortisol and manipulation of motivation.
Detailed description
Investigations description
---------------------------------- Subjects will sit in a rack at a table in front of a 17" screen of an Eye Tracker system (Tobii® T60). The right part of the screen will be covered by a row of operating devices; two rotary knobs of different size, one turn switch and one simple push button. The construction of these devices is based on real ones on board the ISS. Integrated in three of these devices are force sensors (6D ATI® Nano17), which register grip torques and forces while subjects' manipulate the devices.
Four Vicon® Bonita cameras are positioned over the table and attached to a table-fixed metal frame. They will register hand dynamics throughout all grasping movements in normal gravity as well as in microgravity.
In accordance to a classical control task by Kramer (1999) subjects will be asked to control pointer instruments, which are displayed one below the other on the screen. These controls will be embedded in a real life scenario where subjects have to react on specific signals within this scenario: As soon as one of the displayed pointers reach a critical deflection, subjects have to react as fast as possible by grasping towards the associated control device, rotate or push it and turn back to the starting position. This action will bring the pointers back to an uncritical position. The pointers will move independent from the others. Additionally we introduce one compatible and one incompatible pointer-device connection, i.e. the upper pointer can be controlled with the lower device, the middle pointer with the middle and the lower pointer with the upper device.
Equipment used --------------------- Hand movements Hand movements are registered from above and the side by four infrared high-speed cameras (Bonita Vicon-Cameras - CE mark 0088) which register with 250Hz the 3D positions of ten small reflexive markers (attached by double sided adhesive tape to all fingertips and to the thumb of the subjects' right hand). The cameras are connected via cables with an Ultranet which is the central processing unit. The Ultranet is connected with a network cable to a corresponding desktop computer.
Force and torque sensors The different knobs (three of them) that have to be grasped, measure forces and torques applied to it at a rate of 250Hz. These sensors (Nano 17 of the ATI DAQ F/T System) are connected to power supply boxes with a booster, which supplies the data via a DAQ card to the desktop computer. We will analyze usual force parameters such as initial forces at the knob, but also maximal forces applied to the knobs.
Experimental protocol
----------------------------- Before flight subjects will be familiarized with the setup and the protocol. For each flight day, only one subject will be studied. The procedure will be the same on each flight.
Overall one subject will be tested during 26 parabolas. Within the first 13 parabolas motivational state will be manipulated in a positive way by means of positive word presentation (subliminal priming) and within the last 13 parabolas with negative words. The order of positive versus negative priming will be counterbalanced across subjects.
All subjects perform the task of operating control devices once in level flight before the first parabolas, during the parabolas and after the parabolas. After the whole flight subjects will perform the control task again.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human fine motor skills measurements during weightlessness | Other | Other: motion analysis system, Other: parabolic flight |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy volunteers (men or women)
- Aged from 21 to 65
- Right handed
- 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
Key exclusion criteria (4 listed)
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Person with medical history of neurological disorders
- Person with medical history of musculoskeletal disorders of the lower limbs, especially of the ankle and knee joint.
- 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 |
|---|---|---|
| motion analysis system | Other | Human fine motor skills measurements during weightlessness |
| parabolic flight | Other | Human fine motor skills measurements during weightlessness |
Primary outcome
Velocity (deg/sec) of the right hand movement measured with a motion analysis system
Time frame: baseline
Forces (Newton) applied by the hand on the objects to be grasped measured with strain gauges
Time frame: baseline
Torques (N.m) applied by the hand on the objects to be grasped measured with strain gauges
Time frame: baseline
Peak velocity (deg/sec) of the right hand measured with a motin analysis system
Time frame: baseline
Initial force (Newton) on the grasped object measured with strain gauges
Time frame: baseline
Results and safety
Results are not available in the source record.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motion analysis system and 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 4 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Velocity (deg/sec) of the right hand movement measured with a motion analysis system (time frame: baseline). The study lists 5 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.