HealthyPOSTURGRAVNCT02517229
The Effect of Altered Gravity Condition on Postural Control
A study testing Parabolic flight and electromagnetic maneuverable postural platform in people with Healthy, run by University Hospital, Caen at 1 site in France.
Trial summary
The scientific goal of this experiment is to evaluate changes in balance control in response to microgravity during reactive balance tasks. For that purpose, kinematic and neuromuscular parameters under microgravity are compared to normal gravity conditions. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Parabolic flight and electromagnetic maneuverable postural platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to 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
- 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 scientific goal of this experiment is to evaluate changes in balance control in response to microgravity during reactive balance tasks. For that purpose, kinematic and neuromuscular parameters under microgravity are compared to normal gravity conditions. To induce postural responses among the test subjects, an electromagnetic maneuverable postural platform will be used in order to randomly elicit perturbations. Postural reactions will be quantified by means of mechanical and electromyographic data. In Addition, peripheral nerve stimulation will be used to assess the spinal excitability by means of H-reflex recordings. H-reflex measurements were chosen as they allow reliable information about inhibitory and facilitatory mechanisms taking place at the spinal level.
- Conditions
- Healthy
- Being tested
- Parabolic flight, balance control measurements, electromagnetic maneuverable postural platform
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parabolic flightOther
balance control measurementsOther
electromagnetic maneuverable postural platformDevice
| Study group | Role | What they receive |
|---|---|---|
| in balance control in response to microgravity | Other | to evaluate changes in balance control in response to microgravity during reactive balance tasks compared to normal gravity. Receives: Other: Parabolic flight; Other: balance control measurements; Device: electromagnetic maneuverable postural platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance skill, expressed by the postural sway in mm
Measured: baseline
neuromuscular activity, expressed by the Electromyograpy (EMG)-amplitudes
Measured: baseline
spinal excitability, expressed by H-Reflexes
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startSep 2012
- 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 HealthyStudies 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
- 18 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
- NCT02517229
- Sponsor's protocol ID
- 12-084
- Acronym
- POSTURGRAV
- Status last verified
- Aug 2015
- First submitted
- 23 Jul 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Altered Gravity Condition on Postural Control
- ClinicalTrials.gov ID
- NCT02517229
- Acronym / sponsor ID
- POSTURGRAV / 12-084
- Conditions
- Healthy
- Keywords
- volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2015 (estimated)
- First posted
- 6 Aug 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 changes in balance control in response to microgravity during reactive balance tasks. For that purpose, kinematic and neuromuscular parameters under microgravity are compared to normal gravity conditions. To induce postural responses among the test subjects, an electromagnetic maneuverable postural platform will be used in order to randomly elicit perturbations. Postural reactions will be quantified by means of mechanical and electromyographic data. In Addition, peripheral nerve stimulation will be used to assess the spinal excitability by means of H-reflex recordings. H-reflex measurements were chosen as they allow reliable information about inhibitory and facilitatory mechanisms taking place at the spinal level.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| in balance control in response to microgravity | Other | Other: Parabolic flight, Other: balance control measurements, Device: electromagnetic maneuverable postural platformto evaluate changes in balance control in response to microgravity during reactive balance tasks compared to normal gravity. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteers (men or women)
- Aged from 21 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 (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 |
|---|---|---|
| Parabolic flight | Other | in balance control in response to microgravity |
| balance control measurements | Other | in balance control in response to microgravity |
| electromagnetic maneuverable postural platform | Device | in balance control in response to microgravity |
Primary outcome
balance skill, expressed by the postural sway in mm
Time frame: baseline
neuromuscular activity, expressed by the Electromyograpy (EMG)-amplitudes
Time frame: baseline
spinal excitability, expressed by H-Reflexes
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 6 Aug 2015.
Related trials for Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
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 Parabolic flight and electromagnetic maneuverable postural platform in people with Healthy, 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 6 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 6 Aug 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?
balance skill, expressed by the postural sway in mm (time frame: baseline). The study lists 3 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 6 Aug 2015.