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Rendering of a Local 1g Environment for Enhanced Motor Learning in Altered Gravity (Sim1g)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03978910
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Information provided by (Responsible Party):
University Hospital, Caen

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Healthy Other: measurements of the accuracy of the reaching movements Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Rendering of a Local 1g Environment for Enhanced Motor Learning in Altered Gravity
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2021

Arm Intervention/treatment
Experimental: Weigthlessness
during a flight
Other: measurements of the accuracy of the reaching movements
Euclidian distance between final position and target

Primary Outcome Measures :
  1. accuracy of the reaching movements [ Time Frame: baseline ]
    Euclidian distance between final position and target

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03978910

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Contact: Stephane Besnard +33

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Caen Univerity Hospital Recruiting
Caen, France
Contact: Stephane BESNARD         
Sponsors and Collaborators
University Hospital, Caen

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Responsible Party: University Hospital, Caen Identifier: NCT03978910     History of Changes
Other Study ID Numbers: 18-210
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No