NCT02563275

Brief Summary

The aim of this project is to investigate whether alterations in sensory-motor performances during weightlessness are only of theoretical relevance, or indeed restrict the capacity of the participants. To find out, volunteers will monitor a complex realistic process by operation of buttons and switches in weightlessness. The task will mimic the control of vehicles, research equipment and industrial processes. Effects of weightlessness will be separated from effects induced by stress and those of motivation through evaluation of cortisol and manipulation of motivation.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy-volunteers

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

March 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

2.6 years

First QC Date

July 22, 2015

Last Update Submit

September 28, 2015

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

  • Velocity (deg/sec) of the right hand movement measured with a motion analysis system

    baseline

  • Forces (Newton) applied by the hand on the objects to be grasped measured with strain gauges

    baseline

  • Torques (N.m) applied by the hand on the objects to be grasped measured with strain gauges

    baseline

  • Peak velocity (deg/sec) of the right hand measured with a motin analysis system

    baseline

  • Initial force (Newton) on the grasped object measured with strain gauges

    baseline

Study Arms (1)

Human fine motor skills measurements during weightlessness

OTHER
Other: motion analysis systemOther: parabolic flight

Interventions

motion analysis systemOTHER
Human fine motor skills measurements during weightlessness
parabolic flightOTHER
Human fine motor skills measurements during weightlessness

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers (men or women)
  • Aged from 21 to 65
  • Right handed
  • 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 have given their written stated consent
  • Who has 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:

  • Person with medical history of neurological disorders
  • Person with medical history of musculoskeletal disorders of the lower limbs, especially of the ankle and knee joint.
  • 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 22, 2015

First Posted

September 30, 2015

Study Start

March 1, 2013

Primary Completion

October 1, 2015

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

FR(1)