NCT02566213

Brief Summary

The human performance during weightlessness was tested in a multiplicity of laboratory experiments during parabolic flights and in space. It is therefore known that human fine motor skills as grasping are affected by the impact of changing gravity levels. However, because everyday life movements differ in several aspects from those done in an experimental lab situation, investigators do not know until know if this kind of movements is altered in the same extend. Fine motor skills seem to depend on the context in which they are made. Thus, the performance in weightlessness during everyday life could substantially differ from the results given by previous laboratory studies. This assumption will be tested in the present project, with subjects executing one and the same grasping movement in two different contexts, both in normal gravity conditions and in weightlessness. To that end, the investigators developed a new method which allows comparing the same grasping movements under different conditions.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

Enrollment Period

6.2 years

First QC Date

July 28, 2015

Last Update Submit

September 30, 2015

Conditions

Keywords

volunteers

Outcome Measures

Primary Outcomes (4)

  • Gravity induced change in movement time (ms)

    Measured by 3D videocamera, it is the time between the beginning of the hand movement and the contact of the hand on the object

    baseline

  • Gravity induced change in peak velocity of the hand (deg/sec)

    Measured by 3D videocamera

    baseline

  • Gravity induced change in the maximum grip aperture of the hand (mm)

    Measured by 3D videocamera. It is the maximum distance between the first and the fifth digit before hand grasps the object

    baseline

  • Gravity induced change in the initial force applied by the hand on the grasped object (newton)

    Force measured by a strain gauge

    baseline

Study Arms (1)

Motor skills measurements

OTHER
Other: Parabolic flightOther: Motor skills measurements

Interventions

Motor skills measurements

* the kinematics measurements of the right hand with a motion analysis system; * the measurements of forces applied by the hand on the object to be grasped and moved with a 6 degree of freedom force sensor; * the measurement of position of the moved object with an inductive position encoder.

Motor skills measurements

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,
  • right handed,
  • affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
  • who accept to take part in the study,
  • who have given their written stated consent,
  • who have passed a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection.

You may not qualify if:

  • pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

RECRUITING

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

July 28, 2015

First Posted

October 2, 2015

Study Start

October 1, 2010

Primary Completion

December 1, 2016

Last Updated

October 2, 2015

Record last verified: 2015-09

Locations