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The Operation of Control Devices During Parabolic Flights: Influence of Weightlessness, Stress and Motivation (Grafism)

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ClinicalTrials.gov Identifier: NCT02563275
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: motion analysis system Other: parabolic flight Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Operation of Control Devices During Parabolic Flights: Influence of Weightlessness, Stress and Motivation
Study Start Date : March 2013
Estimated Primary Completion Date : October 2015

Arm Intervention/treatment
Human fine motor skills measurements during weightlessness Other: motion analysis system
Other: parabolic flight



Primary Outcome Measures :
  1. Velocity (deg/sec) of the right hand movement measured with a motion analysis system [ Time Frame: baseline ]
  2. Forces (Newton) applied by the hand on the objects to be grasped measured with strain gauges [ Time Frame: baseline ]
  3. Torques (N.m) applied by the hand on the objects to be grasped measured with strain gauges [ Time Frame: baseline ]
  4. Peak velocity (deg/sec) of the right hand measured with a motin analysis system [ Time Frame: baseline ]
  5. Initial force (Newton) on the grasped object measured with strain gauges [ Time Frame: baseline ]


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563275


Locations
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France
Umr Ucbn/Inserm U1075 Comete Recruiting
Caen CEDEX, Basse-Normandie, France, 14032
Contact: Pierre Denise, MD PhD    332068214    pierre.denise@unicaen.fr   
Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02563275    
Other Study ID Numbers: 13-002
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015