- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03978910
Rendering of a Local 1g Environment for Enhanced Motor Learning in Altered Gravity (Sim1g)
June 6, 2019 updated by: University Hospital, Caen
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Caen, France
- Recruiting
- Caen Univerity Hospital
-
Contact:
- Stephane BESNARD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Weigthlessness
during a flight
|
Euclidian distance between final position and target
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
accuracy of the reaching movements
Time Frame: baseline
|
Euclidian distance between final position and target
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Anticipated)
May 30, 2020
Study Completion (Anticipated)
May 30, 2021
Study Registration Dates
First Submitted
June 5, 2019
First Submitted That Met QC Criteria
June 6, 2019
First Posted (Actual)
June 7, 2019
Study Record Updates
Last Update Posted (Actual)
June 7, 2019
Last Update Submitted That Met QC Criteria
June 6, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 18-210
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.