Healthy VolunteersSLS-JUMPNCT02563223
The Effect of Gravity on the Muscular Control of Landing From a Jump
A study testing Parabolic flight and Subject Loading System in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
In this project, investigators propose to study the jump in different reduced gravity fields obtained during parabolic flights profiles but also during increased gravity fields obtained during turns of the airplane or during the pull-up phase of the parabola. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Parabolic flight and Subject Loading System
- 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
- Nov 2011to 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 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 cannot join
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Pregnant women
- Person with medical history of musculoskeletal disorders of the lower limbs, pelvis or spine, neurological or vestibular disorders.
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
In this project, investigators propose to study the jump in different reduced gravity fields obtained during parabolic flights profiles but also during increased gravity fields obtained during turns of the airplane or during the pull-up phase of the parabola. By means of a pneumatic device, an additional pull-down force will be added to the vertical force caused by the gravity field. By combining different levels of gravity to different levels of the added pull-down force it will be possible to dissociate the respective contribution of the otolithic and proprioceptive systems to the anticipatory landing response. To the investigators' knowledge, only one study has modified the gravity field during a jump. However, these authors did not add a pull-down force and only analyzed the vertical ground reaction force.
A better knowledge of the sensory-motor control of the landing phase of a jump will also increase the investigators' understanding of the physiopathology of joint instability. Indeed, similarities could be found between the evolution of the motor response due to the absence gravity during long-duration space flights and the pathological process of chronic ankle and knee instability. The knowledge generated by this study will thus provide invaluable information in the context of human performance and rehabilitation.
Read the detailed description
Investigations description ----------------------------------
During the experiments, subjects will jump in different gravity fields while submitted to an additional pull-down force equal to 0-100% of their body weight on Earth. During the takeoff and landing phases of the jumps, the ground reaction force will be recorded by a force-platform, the movements of the limb segments will be recorded by means of a high-speed camera and the electrical activity (EMG) of the main lower limb muscles will be recorded by means of surface electrodes.
Force platform and Subject Loading System We have developed a device that combines a force platform on which the subject jumps and a Subject Loading System (SLS) that pulls the subject downwards.
The force platform is a 60 cm x 40 cm aluminum plate equipped with four force-transducers that measure the three components of the force exerted by the subject's feet on the ground.
The SLS consists in two pneumatic pistons, which are attached to a harness on one end and to the aluminum plate on the other. The SLS can be set to generate a force equal to 20-100% of the subject's body weight on Earth.
A security handrail (not shown on the picture) is attached to the aluminum plate, around the force-platform in case of unbalance of the subject.
EMG EMG will be recorded with a MyoSystem 1400L using surface electrodes. The skin will be shaved (if necessary) and the electrodes will be attached with double sided tape and plaster. The electrodes will be placed at the level of the lateral gastrocnemius, medial gastrocnemius, tibialis anterior and peroneus longus, and on the thigh at the level of the vastus lateralis, vastus medialis and lateral hamstrings and medial hamstrings. There will be 2 electrodes per muscle (fixed one against the other) and one reference electrode placed at the level of the C7 vertebra.
Manufacturer: Noraxon. Conformity certificate: CE 344
Video Movements of the subject will be recorded by means of a high-speed digital camera (Basler). In order to facilitate video analysis, 7 reflective markers (hemisphere with a 12 mm diameter) will delimit body segments: 3 will be glued on one shoe, 3 will be fixed on the skin (with the same method used for EMG electrodes) at the level of the ankle, knee, hip of one limb and the last one will be fixed on the neck.
Experimental protocol
----------------------------
Before flight subjects will be familiarized with the setup and the protocol. For each flight day, one subject will be studied. The procedure will be the following on all 3 days.
The experiment day starts at 7.30 a.m. with the test subject equipped with EMG electrodes and video markers. After take-off and after work is permitted, the subject goes to the experimental area where it is equipped with the SLS harness. Before each parabola, the subject stands beside the platform to adjust the zero level of the sensor (about 3 second). Then the subject steps on the platform to record his weight (about 3 second).
During the hypergravity initial part in of the parabola, the subject is standing with is two feet on each side of the platform. The traction system is loose (5 kg traction). During the injection, the traction system starts to progressively pull downwards on the subject. The traction force is tuned between 20% and 100% of body weight on Earth. The traction force is constant during each parabola. During the 20 second of weightlessness or partial gravity, the subject jumps several times. At the end of the parabola, the subject puts his feet at the side of the platform and the traction system stops to pull downwards before the pull out phase.
This experiment will also be performed during periods of increased gravity obtained during turns of the airplane. Three turns per flight should be performed at 3 levels of gravity: 1.2, 1.4 g and 1.6 g.
During each parabola or turn, one experimenter is taking care of the control of the traction system and of the collection of the data, a second one takes care of the image acquisition, and a third one takes care of the modification of the configuration of the harness between the parabolas and of the safety of the subject in case of unbalance during the parabolas or during the turn.
- Conditions
- Healthy Volunteers
- Being tested
- Parabolic flight, Subject Loading System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parabolic flightOther
Subject Loading SystemDevice
a device that combines a force platform on which the subject jumps and a Subject Loading System (SLS) that pulls the subject downwards.
| Study group | Role | What they receive |
|---|---|---|
| electromyographic (EMG) measurements | Other | Interaction between gravity (weightlessness, hypergravity, and normal gravity) and pull-down force ont EMG amplitude and EMG timing. Receives: Other: Parabolic flight; Device: Subject Loading System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography (Amplitude - mV and latency - ms)
EMG (electrical activity produced my muscles when they contract) will be recorded with a MyoSystem 1400L using surface electrodes at the level of the lateral gastrocnemius, medial gastrocnemius, tibialis anterior and peroneus longus, and on the thigh at the level of the vastus lateralis, vastus medialis and lateral hamstrings and medial hamstrings.
EMG activation (amplitude and latency) will be measured during jumps at different level of gravity and pull-down forces.
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 startNov 2011
- 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 Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- NCT02563223
- Sponsor's protocol ID
- 11-118
- Acronym
- SLS-JUMP
- Status last verified
- Sep 2015
- First submitted
- 23 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
- The Effect of Gravity on the Muscular Control of Landing From a Jump
- ClinicalTrials.gov ID
- NCT02563223
- Acronym / sponsor ID
- SLS-JUMP / 11-118
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2015 (estimated)
- 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.
In this project, investigators propose to study the jump in different reduced gravity fields obtained during parabolic flights profiles but also during increased gravity fields obtained during turns of the airplane or during the pull-up phase of the parabola. By means of a pneumatic device, an additional pull-down force will be added to the vertical force caused by the gravity field. By combining different levels of gravity to different levels of the added pull-down force it will be possible to dissociate the respective contribution of the otolithic and proprioceptive systems to the anticipatory landing response. To the investigators' knowledge, only one study has modified the gravity field during a jump. However, these authors did not add a pull-down force and only analyzed the vertical ground reaction force.
A better knowledge of the sensory-motor control of the landing phase of a jump will also increase the investigators' understanding of the physiopathology of joint instability. Indeed, similarities could be found between the evolution of the motor response due to the absence gravity during long-duration space flights and the pathological process of chronic ankle and knee instability. The knowledge generated by this study will thus provide invaluable information in the context of human performance and rehabilitation.
Detailed description
Investigations description ----------------------------------
During the experiments, subjects will jump in different gravity fields while submitted to an additional pull-down force equal to 0-100% of their body weight on Earth. During the takeoff and landing phases of the jumps, the ground reaction force will be recorded by a force-platform, the movements of the limb segments will be recorded by means of a high-speed camera and the electrical activity (EMG) of the main lower limb muscles will be recorded by means of surface electrodes.
Force platform and Subject Loading System We have developed a device that combines a force platform on which the subject jumps and a Subject Loading System (SLS) that pulls the subject downwards.
The force platform is a 60 cm x 40 cm aluminum plate equipped with four force-transducers that measure the three components of the force exerted by the subject's feet on the ground.
The SLS consists in two pneumatic pistons, which are attached to a harness on one end and to the aluminum plate on the other. The SLS can be set to generate a force equal to 20-100% of the subject's body weight on Earth.
A security handrail (not shown on the picture) is attached to the aluminum plate, around the force-platform in case of unbalance of the subject.
EMG EMG will be recorded with a MyoSystem 1400L using surface electrodes. The skin will be shaved (if necessary) and the electrodes will be attached with double sided tape and plaster. The electrodes will be placed at the level of the lateral gastrocnemius, medial gastrocnemius, tibialis anterior and peroneus longus, and on the thigh at the level of the vastus lateralis, vastus medialis and lateral hamstrings and medial hamstrings. There will be 2 electrodes per muscle (fixed one against the other) and one reference electrode placed at the level of the C7 vertebra.
Manufacturer: Noraxon. Conformity certificate: CE 344
Video Movements of the subject will be recorded by means of a high-speed digital camera (Basler). In order to facilitate video analysis, 7 reflective markers (hemisphere with a 12 mm diameter) will delimit body segments: 3 will be glued on one shoe, 3 will be fixed on the skin (with the same method used for EMG electrodes) at the level of the ankle, knee, hip of one limb and the last one will be fixed on the neck.
Experimental protocol
----------------------------
Before flight subjects will be familiarized with the setup and the protocol. For each flight day, one subject will be studied. The procedure will be the following on all 3 days.
The experiment day starts at 7.30 a.m. with the test subject equipped with EMG electrodes and video markers. After take-off and after work is permitted, the subject goes to the experimental area where it is equipped with the SLS harness. Before each parabola, the subject stands beside the platform to adjust the zero level of the sensor (about 3 second). Then the subject steps on the platform to record his weight (about 3 second).
During the hypergravity initial part in of the parabola, the subject is standing with is two feet on each side of the platform. The traction system is loose (5 kg traction). During the injection, the traction system starts to progressively pull downwards on the subject. The traction force is tuned between 20% and 100% of body weight on Earth. The traction force is constant during each parabola. During the 20 second of weightlessness or partial gravity, the subject jumps several times. At the end of the parabola, the subject puts his feet at the side of the platform and the traction system stops to pull downwards before the pull out phase.
This experiment will also be performed during periods of increased gravity obtained during turns of the airplane. Three turns per flight should be performed at 3 levels of gravity: 1.2, 1.4 g and 1.6 g.
During each parabola or turn, one experimenter is taking care of the control of the traction system and of the collection of the data, a second one takes care of the image acquisition, and a third one takes care of the modification of the configuration of the harness between the parabolas and of the safety of the subject in case of unbalance during the parabolas or during the turn.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electromyographic (EMG) measurements | Other | Other: Parabolic flight, Device: Subject Loading SystemInteraction between gravity (weightlessness, hypergravity, and normal gravity) and pull-down force ont EMG amplitude and EMG timing. |
Who may qualify
- Ages
- 18 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 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 (3 listed)
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Pregnant women
- Person with medical history of musculoskeletal disorders of the lower limbs, pelvis or spine, neurological or vestibular disorders.
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 | electromyographic (EMG) measurements |
| Subject Loading Systema device that combines a force platform on which the subject jumps and a Subject Loading System (SLS) that pulls the subject downwards. | Device | electromyographic (EMG) measurements |
Primary outcome
Electromyography (Amplitude - mV and latency - ms)
Time frame: baseline
EMG (electrical activity produced my muscles when they contract) will be recorded with a MyoSystem 1400L using surface electrodes at the level of the lateral gastrocnemius, medial gastrocnemius, tibialis anterior and peroneus longus, and on the thigh at the level of the vastus lateralis, vastus medialis and lateral hamstrings and medial hamstrings. EMG activation (amplitude and latency) will be measured during jumps at different level of gravity and pull-down forces.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
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Screening Protocol
Pain
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 Subject Loading System in people with Healthy Volunteers, 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 3 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 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?
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?
Electromyography (Amplitude - mV and latency - ms) (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.