Healthy VolunteersDEXTER0gNCT02563249
Influence of Gravity on Dexterity, Hand-eye Coordination and Perception of Orientation and Distances
A study testing Parabolic flight and movements of the upper limb, the gripping force, muscle activity and eye-cephalic subject movement measurements in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
Trial summary
If investigators know that the anticipatory mechanisms involved in precision grip take into account the gravity, however it is unclear how they adapt to changes in the gravitational level. 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 movements of the upper limb, the gripping force, muscle activity and eye-cephalic subject movement measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Dec 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, male or female
- 18 to 65 years
- Affiliated with a Social Security plan or holder of a European Health Insurance Card (EHIC - European Health Insurance Card - EHIC).
- Having an aeronautical medical certificate of fitness for flight personnel unprofessional functions in civil aviation.
- Agreeing to participate in the study
- Having given informed consent
Who cannot join
- person not affiliated to a Social Security Inssurance,
- person who participated in a clinical trial within the trial below the exclusion period,
- person with a medical history or any acute or chronic condition that can affect the test results, or by running a risk on during the protocol, especially topics: past or present history of neurological disease, rheumatologic or otologic (hearing or equilibration) OR person with a corrected visual acuity of less than 5 / 10th.
- 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
If investigators know that the anticipatory mechanisms involved in precision grip take into account the gravity, however it is unclear how they adapt to changes in the gravitational level. The objectives of this study are to study and model the movement control and the mechanisms underlying learning and adapting to the condition of weightlessness. Specifically, i) investigators will determine if a change in the level of gravity is taken into account when controlling grip force and ii) investigators will examine the effects of gravity change on hand-eye coordination.
- Conditions
- Healthy Volunteers
- Being tested
- Parabolic flight, movements of the upper limb, the gripping force, muscle activity and eye-cephalic subject movement measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parabolic flightOther
movements of the upper limb, the gripping force, muscle activity and eye-cephalic subject movement measurementsOther
| Study group | Role | What they receive |
|---|---|---|
| Dexterity, Coordination,Perception measurements | Other | Dexterity, Hand-eye Coordination and Perception of Orientation and Distances Receives: Other: Parabolic flight; Other: movements of the upper limb, the gripping force, muscle activity and eye-cephalic subject movement measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gravity induced changes in grip strength (newton) exerted between the fingers measured with strain gauges
Measured: baseline
Gravity induced changes in oculo-manual coordination measured by the latency (ms) of anticipatory eye movement measurement with videooculography
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 startMay 2012
- Primary completionDec 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
- 90 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
- NCT02563249
- Sponsor's protocol ID
- 12-026
- Acronym
- DEXTER0g
- 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
- Influence of Gravity on Dexterity, Hand-eye Coordination and Perception of Orientation and Distances
- ClinicalTrials.gov ID
- NCT02563249
- Acronym / sponsor ID
- DEXTER0g / 12-026
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 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.
If investigators know that the anticipatory mechanisms involved in precision grip take into account the gravity, however it is unclear how they adapt to changes in the gravitational level. The objectives of this study are to study and model the movement control and the mechanisms underlying learning and adapting to the condition of weightlessness. Specifically, i) investigators will determine if a change in the level of gravity is taken into account when controlling grip force and ii) investigators will examine the effects of gravity change on hand-eye coordination.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexterity, Coordination,Perception measurements | Other | Other: Parabolic flight, Other: movements of the upper limb, the gripping force, muscle activity and eye-cephalic subject movement measurementsDexterity, Hand-eye Coordination and Perception of Orientation and Distances |
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, male or female
- 18 to 65 years
- Affiliated with a Social Security plan or holder of a European Health Insurance Card (EHIC - European Health Insurance Card - EHIC).
- Having an aeronautical medical certificate of fitness for flight personnel unprofessional functions in civil aviation.
- Agreeing to participate in the study
Key exclusion criteria (4 listed)
- person not affiliated to a Social Security Inssurance,
- person who participated in a clinical trial within the trial below the exclusion period,
- person with a medical history or any acute or chronic condition that can affect the test results, or by running a risk on during the protocol, especially topics: past or present history of neurological disease, rheumatologic or otologic (hearing or equilibration) OR person with a corrected visual acuity of less than 5 / 10th.
- 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 | Dexterity, Coordination,Perception measurements |
| movements of the upper limb, the gripping force, muscle activity and eye-cephalic subject movement measurements | Other | Dexterity, Coordination,Perception measurements |
Primary outcome
Gravity induced changes in grip strength (newton) exerted between the fingers measured with strain gauges
Time frame: baseline
Gravity induced changes in oculo-manual coordination measured by the latency (ms) of anticipatory eye movement measurement with videooculography
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 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 movements of the upper limb, the gripping force, muscle activity and eye-cephalic subject movement measurements 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 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 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?
Gravity induced changes in grip strength (newton) exerted between the fingers measured with strain gauges (time frame: baseline). The study lists 2 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 30 Sep 2015.