HealthyFINESKILLNCT02566213
Human Fine-motor-skills in Weightlessness: Comparison of a Laboratory and an Everyday-like Context
A study testing Parabolic flight and Motor skills measurements in people with Healthy, run by University Hospital, Caen at 1 site in France.
Trial summary
The human performance during weightlessness was tested in a multiplicity of laboratory experiments during parabolic flights and in space. It is therefore known that human fine motor skills as grasping are affected by the impact of changing gravity levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Parabolic flight and Motor skills measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Dec 2016
- 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,
- right handed,
- affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
- who accept to take part in the study,
- who have given their written stated consent,
- who have 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.
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 human performance during weightlessness was tested in a multiplicity of laboratory experiments during parabolic flights and in space. It is therefore known that human fine motor skills as grasping are affected by the impact of changing gravity levels. However, because everyday life movements differ in several aspects from those done in an experimental lab situation, investigators do not know until know if this kind of movements is altered in the same extend.
Fine motor skills seem to depend on the context in which they are made. Thus, the performance in weightlessness during everyday life could substantially differ from the results given by previous laboratory studies.
This assumption will be tested in the present project, with subjects executing one and the same grasping movement in two different contexts, both in normal gravity conditions and in weightlessness. To that end, the investigators developed a new method which allows comparing the same grasping movements under different conditions.
Read the detailed description
Investigations description Subjects sit at a table in front of a 15" computer screen, a centrally located joystick and a sliding lever on the right side. All devices are fixed to the table.
The subjects hand is fitted with six adhesive reflexive markers so that hand movements can be registered from above by two MX-F20 Vicon-Cameras, attached to a table-fixed metal frame. Lever forces are registered by an ATI Nano17 force transducers, lever fore-aft position by an inductive encoder, and eye position by an eye tracker (Tobii T60).
Subjects will perform two different tasks, one representing a typical laboratory (L), one an everyday-like task (E). In task L, a visual stimulus on the screen will prompt subjects to release the joystick, grasp the lever, move it forwards and back, and then return their hand to the joystick. In task E, subjects will use the joystick in a computer game ("spider chasing") and occasionally release the joystick, grasp the lever, move it forwards and back in order to collect a reward, and then return their hand to the joystick. In both tasks the visual stimuli are accompanied with acoustic signals. To hear these signals during the flight procedure, subjects are equipped with ear-phones, plugged into a laptop.
In one 20 second microgravity episode, task L will be performed five times or task E twice. The investigator starts each task with a click on the keyboard and it stops automatically after 20sec.
Control data will be registered from each subject for the same length of time during level flight at 1g.
During the whole test procedure the subject is not constraint in its natural behaviour except by an easy to open belt which fixes the subject to the chair. The subject can at any time end the experiment.
Equipment used For hand motion measurement and analysis we use a Vicon MX System, consisting of two MX20+ infrared high-speed cameras, each connected via cables with an MX Ultranet which processes the data. The Ultranet is connected with a network cable to a corresponding laptop (Dell).
Force is measured by a 6 degree of freedom force transducer which is part of an ATI DAQ F/T System, consisting of the force sensor Nano 17, a power supply box with booster and a 16-bit A/D converter (DAQ-Card, NI 6036E). It uses the PCMCIA bus of a second laptop (Fujitsu).
The position of the object to move is measured by an inductive position encoder (dc position encoder type 8740-5100 by burster).
The eye movement will be recorded by a standard USB-camera or a commercial eye-tracker (Tobii T60) when available.
All devices are commercially available and are used according their CE marking.
Experimental protocol Before flight subjects will be familiarised with the protocol. Two subjects will be studied during each flight. On ground, each subject gets 6 reflexive markers (6mm diameter) stuck on their right hand (4 on index, 2 on thumb, fixed with double sided adhesive tape).
The first subject takes a seat at the experimental set-up, the second one on an aircraft seat. The tested subject is then equipped with ear-phones plugged into a laptop. It helps to focus the attention on the tasks which are accompanied with acoustic signals. Recording devices are then adjusted to the subject by a standard calibration procedure, done by the test-operator. Before entering the first parabola the subject executes the same two grasping-tasks on level flight. After the first test parabola, during each 0g period it has to execute the grasping movements in one of each task - 4 parabolas task L with five episodes each, 10 parabolas task E with two episodes each. Entering the 0g phase the operator starts the test by a click on the keyboard, afterwards the tasks stop automatically. During 1g and 1,8g phases the test is interrupted. After the 15th parabola the subjects switch places and the second one starts with the tests during the 0g phases. On level flight back to the airport it executes the same two tasks again as control condition.
- Conditions
- Healthy
- Being tested
- Parabolic flight, Motor skills measurements
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parabolic flightOther
Motor skills measurementsOther
- the kinematics measurements of the right hand with a motion analysis system;
- the measurements of forces applied by the hand on the object to be grasped and moved with a 6 degree of freedom force sensor;
- the measurement of position of the moved object with an inductive position encoder.
| Study group | Role | What they receive |
|---|---|---|
| Motor skills measurements | Other | Not described Receives: Other: Parabolic flight; Other: Motor skills measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gravity induced change in movement time (ms)
Measured by 3D videocamera, it is the time between the beginning of the hand movement and the contact of the hand on the object
Measured: baseline
Gravity induced change in peak velocity of the hand (deg/sec)
Measured by 3D videocamera
Measured: baseline
Gravity induced change in the maximum grip aperture of the hand (mm)
Measured by 3D videocamera. It is the maximum distance between the first and the fifth digit before hand grasps the object
Measured: baseline
Gravity induced change in the initial force applied by the hand on the grasped object (newton)
Force measured by a strain gauge
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startOct 2010
- Primary completionDec 2016 (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.
- 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
- NCT02566213
- Sponsor's protocol ID
- 10-084
- Acronym
- FINESKILL
- Status last verified
- Sep 2015
- First submitted
- 28 Jul 2015
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Fine-motor-skills in Weightlessness: Comparison of a Laboratory and an Everyday-like Context
- ClinicalTrials.gov ID
- NCT02566213
- Acronym / sponsor ID
- FINESKILL / 10-084
- 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
- Oct 2010
- Primary completion
- Dec 2016 (estimated)
- First posted
- 2 Oct 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 human performance during weightlessness was tested in a multiplicity of laboratory experiments during parabolic flights and in space. It is therefore known that human fine motor skills as grasping are affected by the impact of changing gravity levels. However, because everyday life movements differ in several aspects from those done in an experimental lab situation, investigators do not know until know if this kind of movements is altered in the same extend.
Fine motor skills seem to depend on the context in which they are made. Thus, the performance in weightlessness during everyday life could substantially differ from the results given by previous laboratory studies.
This assumption will be tested in the present project, with subjects executing one and the same grasping movement in two different contexts, both in normal gravity conditions and in weightlessness. To that end, the investigators developed a new method which allows comparing the same grasping movements under different conditions.
Detailed description
Investigations description Subjects sit at a table in front of a 15" computer screen, a centrally located joystick and a sliding lever on the right side. All devices are fixed to the table.
The subjects hand is fitted with six adhesive reflexive markers so that hand movements can be registered from above by two MX-F20 Vicon-Cameras, attached to a table-fixed metal frame. Lever forces are registered by an ATI Nano17 force transducers, lever fore-aft position by an inductive encoder, and eye position by an eye tracker (Tobii T60).
Subjects will perform two different tasks, one representing a typical laboratory (L), one an everyday-like task (E). In task L, a visual stimulus on the screen will prompt subjects to release the joystick, grasp the lever, move it forwards and back, and then return their hand to the joystick. In task E, subjects will use the joystick in a computer game ("spider chasing") and occasionally release the joystick, grasp the lever, move it forwards and back in order to collect a reward, and then return their hand to the joystick. In both tasks the visual stimuli are accompanied with acoustic signals. To hear these signals during the flight procedure, subjects are equipped with ear-phones, plugged into a laptop.
In one 20 second microgravity episode, task L will be performed five times or task E twice. The investigator starts each task with a click on the keyboard and it stops automatically after 20sec.
Control data will be registered from each subject for the same length of time during level flight at 1g.
During the whole test procedure the subject is not constraint in its natural behaviour except by an easy to open belt which fixes the subject to the chair. The subject can at any time end the experiment.
Equipment used For hand motion measurement and analysis we use a Vicon MX System, consisting of two MX20+ infrared high-speed cameras, each connected via cables with an MX Ultranet which processes the data. The Ultranet is connected with a network cable to a corresponding laptop (Dell).
Force is measured by a 6 degree of freedom force transducer which is part of an ATI DAQ F/T System, consisting of the force sensor Nano 17, a power supply box with booster and a 16-bit A/D converter (DAQ-Card, NI 6036E). It uses the PCMCIA bus of a second laptop (Fujitsu).
The position of the object to move is measured by an inductive position encoder (dc position encoder type 8740-5100 by burster).
The eye movement will be recorded by a standard USB-camera or a commercial eye-tracker (Tobii T60) when available.
All devices are commercially available and are used according their CE marking.
Experimental protocol Before flight subjects will be familiarised with the protocol. Two subjects will be studied during each flight. On ground, each subject gets 6 reflexive markers (6mm diameter) stuck on their right hand (4 on index, 2 on thumb, fixed with double sided adhesive tape).
The first subject takes a seat at the experimental set-up, the second one on an aircraft seat. The tested subject is then equipped with ear-phones plugged into a laptop. It helps to focus the attention on the tasks which are accompanied with acoustic signals. Recording devices are then adjusted to the subject by a standard calibration procedure, done by the test-operator. Before entering the first parabola the subject executes the same two grasping-tasks on level flight. After the first test parabola, during each 0g period it has to execute the grasping movements in one of each task - 4 parabolas task L with five episodes each, 10 parabolas task E with two episodes each. Entering the 0g phase the operator starts the test by a click on the keyboard, afterwards the tasks stop automatically. During 1g and 1,8g phases the test is interrupted. After the 15th parabola the subjects switch places and the second one starts with the tests during the 0g phases. On level flight back to the airport it executes the same two tasks again as control condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motor skills measurements | Other | Other: Parabolic flight, Other: Motor skills measurements |
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,
- right handed,
- affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
- who accept to take part in the study,
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 |
|---|---|---|
| Parabolic flight | Other | Motor skills measurements |
| Motor skills measurements* the kinematics measurements of the right hand with a motion analysis system; * the measurements of forces applied by the hand on the object to be grasped and moved with a 6 degree of freedom force sensor; * the measurement of position of the moved object with an inductive position encoder. | Other | Motor skills measurements |
Primary outcome
Gravity induced change in movement time (ms)
Time frame: baseline
Measured by 3D videocamera, it is the time between the beginning of the hand movement and the contact of the hand on the object
Gravity induced change in peak velocity of the hand (deg/sec)
Time frame: baseline
Measured by 3D videocamera
Gravity induced change in the maximum grip aperture of the hand (mm)
Time frame: baseline
Measured by 3D videocamera. It is the maximum distance between the first and the fifth digit before hand grasps the object
Gravity induced change in the initial force applied by the hand on the grasped object (newton)
Time frame: baseline
Force measured by a strain gauge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 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.
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 Motor skills measurements 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 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: status not confirmed, as of the sponsor's last update on 2 Oct 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?
Gravity induced change in movement time (ms) (time frame: baseline). The study lists 4 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 2 Oct 2015.