- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02850380
Spatial Orientation and Motor Skills: How to Flip Switches "Down" in Weightlessness? (Down)
July 27, 2016 updated by: University Hospital, Caen
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:
- will be biased towards visual allocentric cues when those are available;
- will be biased towards the egocentric reference when tactile cues are added;
- will be dominated by egocentric cues when visual cues are not available;
- will be delayed and more variable when confirmatory gravitational cues are absent;
- will be faster and more reliable in absence of conflicting gravitational cues, and even more so when tactile cues are added;
- The difference will be more pronounce when tested under Dual-task condition
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, 14000
- Recruiting
- Caen CHU
-
-
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
20 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 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 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
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: spatial orientation in weightlessness
subjects will be asked to flip a series of switches into the "off" position.
On Earth, the "off" position corresponds to "down" in all three reference frames: the visual allocentric, the non-visual allocentric as well as the egocentric frames.
We expect that flip direction will be dominated by visual allocentric cues when those are available, will be delayed and more variable when confirmatory gravitational cues are absent, and will be biased towards the egocentric reference when tactile cues are added
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
reaction time of flip switch measured with a chronometer
Time Frame: baseline
|
baseline
|
|
Direction of flip switch measured with the circular instrument panel
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pierre DP Denise, PhD, CHU Caen
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
September 1, 2015
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
September 1, 2018
Study Registration Dates
First Submitted
April 21, 2016
First Submitted That Met QC Criteria
July 27, 2016
First Posted (Estimate)
August 1, 2016
Study Record Updates
Last Update Posted (Estimate)
August 1, 2016
Last Update Submitted That Met QC Criteria
July 27, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 2015-A01261-48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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