Healthy ParticipantsHYDRONAUTNCT02563262
Human Neutral Body Posture in Weightlessness
A study testing body angles measurements during weightlessness in people with Healthy Participants, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- body angles measurements during weightlessness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Jan 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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
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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- body angles measurements during weightlessness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body angles measurements during weightlessnessOther
| Study group | Role | What they receive |
|---|---|---|
| body angles measurements during weightlessness | Other | body angles : ankle, knee, hip, shoulder, elbow, wrist, and neck. Receives: Other: body angles measurements during weightlessness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint angles
Angles of several joints (ankle, knee, hip, shoulder, elbow, wrist, and neck) measured with video cameras
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 startSep 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- 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
- 8 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
- NCT02563262
- Sponsor's protocol ID
- 12-122
- Acronym
- HYDRONAUT
- 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
- Human Neutral Body Posture in Weightlessness
- ClinicalTrials.gov ID
- NCT02563262
- Acronym / sponsor ID
- HYDRONAUT / 12-122
- Conditions
- Healthy Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| body angles measurements during weightlessness | Other | Other: body angles measurements during weightlessnessbody angles : ankle, knee, hip, shoulder, elbow, wrist, and neck. |
Who may qualify
- Ages
- 18 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 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
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 |
|---|---|---|
| body angles measurements during weightlessness | Other | body angles measurements during weightlessness |
Primary outcome
Joint angles
Time frame: baseline
Angles of several joints (ankle, knee, hip, shoulder, elbow, wrist, and neck) measured with video cameras
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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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 body angles measurements during weightlessness in people with Healthy Participants, 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?
Joint angles (time frame: baseline). 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.