- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02563262
Human Neutral Body Posture in Weightlessness (HYDRONAUT)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Basse-Normandie
-
Caen CEDEX, Basse-Normandie, France, 14032
- Umr Ucbn/Inserm U1075 Comete
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: body angles measurements during weightlessness
body angles : ankle, knee, hip, shoulder, elbow, wrist, and neck.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint angles
Time Frame: baseline
|
Angles of several joints (ankle, knee, hip, shoulder, elbow, wrist, and neck) measured with video cameras
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 12-122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Participants
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Not yet recruitingHealthy Participants | Healthy Adult ParticipantsUnited States
-
Touro University, CaliforniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingHealthy Participants | Obese But Otherwise Healthy ParticipantsUnited States
-
Beijing Tide Pharmaceutical Co., LtdRecruitingHealthy | Healthy ParticipantsChina
-
Aston UniversityCooperVision, Inc.Enrolling by invitationHealthy | Healthy ParticipantsUnited Kingdom
-
Universidad San SebastiánAgencia Nacional de Investigación y DesarrolloNot yet recruitingHealthy | Healthy Adult ParticipantsChile
-
Standard Process Inc.Recruiting
-
PfizerCompletedHealthy Subjects | Healthy ParticipantsUnited States
-
Hoffmann-La RocheNot yet recruiting
-
Simcere Pharmaceutical Co., LtdNot yet recruiting
Clinical Trials on body angles measurements during weightlessness
-
University Health Network, TorontoCompletedAtrial Fibrillation | Heart DiseaseCanada
-
Applied CognitionUniversity of Florida HealthCompleted
-
University of PittsburghMedtronicWithdrawnIschemic Cardiomyopathy | CardiomyopathyUnited States
-
Shenzhen Institutes of Advanced Technology ,Chinese...Not yet recruiting
-
Ege UniversityCompletedBody Temperature Changes
-
Medical University of ViennaUnknownBody Composition | UltrasoundAustria
-
Vrije Universiteit BrusselKU LeuvenCompletedBody Weight | Pregnancy | Health Behavior | First PregnancyBelgium
-
Johns Hopkins UniversityVital StrategiesCompletedCardiovascular Diseases | Hypertension | Blood Pressure | Cardiovascular Risk FactorUnited States
-
Kantonsspital Winterthur KSWNot yet recruitingUrodynamic Studies | Outlet Obstruction | Urodynamics
-
Artromedical Konrad Malinowski ClinicRecruitingAnalysis of Radiological Features of Lateral Femoral Impaction Fracture / Lateral Femoral Notch SignAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearPoland