Spatial Orientation and Motor Skills: How to Flip Switches "Down" in Weightlessness?

Healthy Volunteers Clinical Trial

— Down  

Official title:

Spatial Orientation and Motor Skills: How to Flip Switches "Down" in Weightlessness?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02850380
• Other study ID #: 2015-A01261-48
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2016
• Last updated: July 27, 2016
• Start date: September 2015
• Est. completion date: September 2018

Study information

• Verified date: July 2016
• Source: University Hospital, Caen
• Contact: Pierre DP Denise, PhD
• Phone: 02.31.06.81.32
• Email: pierre.denise[@]unicaen.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate spatial orientation in weightlessness as it manifests not in perception but rather in motor performance by direction and reaction time of flip switch.

Hypotheses are that flip switch:

1. will be biased towards visual allocentric cues when those are available;

2. will be biased towards the egocentric reference when tactile cues are added;

3. will be dominated by egocentric cues when visual cues are not available;

4. will be delayed and more variable when confirmatory gravitational cues are absent;

5. will be faster and more reliable in absence of conflicting gravitational cues, and even more so when tactile cues are added;

6. The difference will be more pronounce when tested under Dual-task condition

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers (men or women)

• Aged from 20 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 have given their written stated consent

• Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign

Exclusion Criteria:

• Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated

• Person who has already participated in a parabolic flight

• Pregnant women

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• FLIP SWITCHES "DOWN" IN WEIGHTLESSNESS
The circular instrument panel that subjects will see into the cylindrical mask consists of one switch surrounded by a luminous ring (left part of the figure below). The switch can be flipped into any direction within the full 360° range. The switch provides no visual cues about "down", but the experimenter can add such cues by means of visually polarized labelling displayed on a circular black screen at the center of the panel (right part the figure below).

Locations

Country	Name	City	State
France	Caen CHU	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Novespace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reaction time of flip switch measured with a chronometer		baseline	No
Primary	Direction of flip switch measured with the circular instrument panel		baseline	No