HealthySim1gNCT03978910
Rendering of a Local 1g Environment for Enhanced Motor Learning in Altered Gravity
A study testing measurements of the accuracy of the reaching movements in people with Healthy, run by University Hospital, Caen at 1 site in France.
Trial summary
Human motor adaptation is crucial to adapt to new environments, such as altered gravity. Dexterous manipulation and fine movements in space require learning new coordinated motor actions. 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?
- measurements of the accuracy of the reaching movements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 30 May 2021
- 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 can take scopolamine or nautamine (medication against airsickness).
- Who have given their informed written stated consent.
- Who have passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination) and have been declared fit to fly. The examination must be less than one year before the experiment flight. There will be no additional test performed for participant selection.
Who cannot join
- Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated.
- Persons with any history of cerebral, cardiovascular or vestibular diseases.
- Persons with history of psychiatric diseases, including anxiety disorder.
- Persons whose medical condition has changed since the class 2-like medical examination.
- Pregnant women (urine pregnancy test for women of childbearing potential).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen Univerity Hospital
Caen
Stephane BESNARD
About this study
Human motor adaptation is crucial to adapt to new environments, such as altered gravity. Dexterous manipulation and fine movements in space require learning new coordinated motor actions. Traditionally, adaptation mechanisms have been tested in laboratories with robotic devices that perturb specific task parameters unbeknownst to the participant. Over repetition, participants build a more accurate representation of the task dynamics and, eventually, improve performance. These perturbations are applied locally on the hand or limb while the dynamics of the rest of the body remains unaltered. These approaches are therefore limitative since they do not reflect ecological adaptation to globally changed dynamics, such as new gravitational environments. Parabolic flights, centrifuges and water immersion allow circumventing these limitations. Previous investigations in these contexts have highlighted the role of the global context in motor adaptation. However, it is unknown if global learning could benefit from exploiting known local dynamics. Here, we design an original task that will capture both the learning of arm movement kinematics as well as grasping forces for object manipulation in an ecologically valid design. We test whether executing this task in hypogravity with rendering of Earth gravity locally at the hand is beneficial or detrimental to task performance. By adopting the "negative picture" of conventional robotic approaches, these results will further our understanding of basic motor adaptation and provide insightful information on the optimal design and control of human-machine interfaces and wearable robots in space environments and other immersive dynamics.
- Conditions
- Healthy
- Being tested
- measurements of the accuracy of the reaching movements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurements of the accuracy of the reaching movementsOther
Euclidian distance between final position and target
| Study group | Role | What they receive |
|---|---|---|
| Weigthlessness | Experimental | during a flight Receives: Other: measurements of the accuracy of the reaching movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of the reaching movements
Euclidian distance between final position and target
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Apr 2019
- Primary completion30 May 2020 (estimated)
- Study completion30 May 2021 (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
- NCT03978910
- Sponsor's protocol ID
- 18-210
- Acronym
- Sim1g
- Status last verified
- Jun 2019
- First submitted
- 5 Jun 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rendering of a Local 1g Environment for Enhanced Motor Learning in Altered Gravity
- ClinicalTrials.gov ID
- NCT03978910
- Acronym / sponsor ID
- Sim1g / 18-210
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 7 Jun 2019 (actual)
- 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.
Human motor adaptation is crucial to adapt to new environments, such as altered gravity. Dexterous manipulation and fine movements in space require learning new coordinated motor actions. Traditionally, adaptation mechanisms have been tested in laboratories with robotic devices that perturb specific task parameters unbeknownst to the participant. Over repetition, participants build a more accurate representation of the task dynamics and, eventually, improve performance. These perturbations are applied locally on the hand or limb while the dynamics of the rest of the body remains unaltered. These approaches are therefore limitative since they do not reflect ecological adaptation to globally changed dynamics, such as new gravitational environments. Parabolic flights, centrifuges and water immersion allow circumventing these limitations. Previous investigations in these contexts have highlighted the role of the global context in motor adaptation. However, it is unknown if global learning could benefit from exploiting known local dynamics. Here, we design an original task that will capture both the learning of arm movement kinematics as well as grasping forces for object manipulation in an ecologically valid design. We test whether executing this task in hypogravity with rendering of Earth gravity locally at the hand is beneficial or detrimental to task performance. By adopting the "negative picture" of conventional robotic approaches, these results will further our understanding of basic motor adaptation and provide insightful information on the optimal design and control of human-machine interfaces and wearable robots in space environments and other immersive dynamics.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weigthlessness | Experimental | Other: measurements of the accuracy of the reaching movementsduring a flight |
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 can take scopolamine or nautamine (medication against airsickness).
Key exclusion criteria (5 listed)
- Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated.
- Persons with any history of cerebral, cardiovascular or vestibular diseases.
- Persons with history of psychiatric diseases, including anxiety disorder.
- Persons whose medical condition has changed since the class 2-like medical examination.
- Pregnant women (urine pregnancy test for women of childbearing potential).
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 |
|---|---|---|
| measurements of the accuracy of the reaching movementsEuclidian distance between final position and target | Other | Weigthlessness |
Primary outcome
accuracy of the reaching movements
Time frame: baseline
Euclidian distance between final position and target
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
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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 measurements of the accuracy of the reaching movements 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 5 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 7 Jun 2019. 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?
Contact Stephane Besnard (+33 231.06.81.64, stephane.besnard@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of the reaching movements (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 7 Jun 2019.