NCT03978910

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

1.2 years

First QC Date

June 5, 2019

Last Update Submit

June 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • accuracy of the reaching movements

    Euclidian distance between final position and target

    baseline

Study Arms (1)

Weigthlessness

EXPERIMENTAL

during a flight

Other: measurements of the accuracy of the reaching movements

Interventions

Euclidian distance between final position and target

Weigthlessness

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen Univerity Hospital

Caen, France

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 7, 2019

Study Start

April 1, 2019

Primary Completion

May 30, 2020

Study Completion

May 30, 2021

Last Updated

June 7, 2019

Record last verified: 2019-06

Locations