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Human Neutral Body Posture in Weightlessness (HYDRONAUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563262
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
The scientific goal of this experiment is to evaluate the performances of our three-dimensional digital model by comparing its prediction computed from underwater data to posture observed during real weightlessness during parabolic flight.

Condition or disease Intervention/treatment Phase
Healthy Participants Other: body angles measurements during weightlessness Not Applicable

Detailed Description:

Investigations description Throughout the experiment test subject will be safely attached to a fixation mechanism at its center of gravity (hip). This mechanism comprises a climbing harness connected to two lateral vertical guides by two magnetic connection plates at the level of the hips. The test subject will lie down on the floor on a plate equipped with foam pads to create a comfortable lying surface. This mechanism allows free postural movement in microgravity phase and also supports the test subject´s lying position during 1,8g- phase. At any stage of the experiment the test subject will be able to exit the fixation alone, by using one hand only.

The harness can be moved vertically by a linear sliding system and springs in the vertical guides. Springs will remain compressed during the 1g/2g-phase and lift the subject with the reduction to microgravity.

At the beginning of the weightlessness phase of each parabola, the sliding system will push participant's body up to about 30cm above the floor. After he has reached the free floating position, he will be asked to perform a short effort (crouching or stretching) and then to relax and stay still.

Once free floating, three video cameras with wide angle lenses will record body movements from front, side and top view. By electronically synchronizing the cameras the produced images can be used for three-dimensional analysis. Additionally three-dimensional force sensors at the hip fixation will be used to evaluate the quality of microgravity provided during the parabolic flight.

Experimental protocol Before flight subjects will be familiarized with the setup and the protocol. For each flight day, 3 subjects will be studied. The procedure will be the same for the 3 subjects and on all 3 days.

The subject rests calm at the bottom until microgravity phase starts. As described above a spring forced linear sliding system will push his body mass up to about 300mm. After the test subject has reached its free floating position without any contact to the surrounding area (bottom), he will perform a short effort (crouching or stretching). From now on the subject should relax and is not allowed to move his muscles intentionally. At the end of microgravity phase, the sliding system will allow a soft landing on the foam pads.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : September 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
body angles measurements during weightlessness
body angles : ankle, knee, hip, shoulder, elbow, wrist, and neck.
Other: body angles measurements during weightlessness



Primary Outcome Measures :
  1. Joint angles [ Time Frame: baseline ]
    Angles of several joints (ankle, knee, hip, shoulder, elbow, wrist, and neck) measured with video cameras



Information from the National Library of Medicine

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Ages Eligible for Study:   18 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 18 to 65
  • 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 already participated in a underwater test in Munich

Exclusion Criteria:

  • Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
  • 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): NCT02563262


Locations
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France
Umr Ucbn/Inserm U1075 Comete
Caen CEDEX, Basse-Normandie, France, 14032
Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02563262    
Other Study ID Numbers: 12-122
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015