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Influence of Gravity on Dexterity, Hand-eye Coordination and Perception of Orientation and Distances (DEXTER0g)

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ClinicalTrials.gov Identifier: NCT02563249
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Tracking Information
First Submitted Date  ICMJE July 23, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date September 30, 2015
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • Gravity induced changes in grip strength (newton) exerted between the fingers measured with strain gauges [ Time Frame: baseline ]
  • Gravity induced changes in oculo-manual coordination measured by the latency (ms) of anticipatory eye movement measurement with videooculography [ Time Frame: baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Gravity on Dexterity, Hand-eye Coordination and Perception of Orientation and Distances
Official Title  ICMJE Not Provided
Brief Summary If investigators know that the anticipatory mechanisms involved in precision grip take into account the gravity, however it is unclear how they adapt to changes in the gravitational level. The objectives of this study are to study and model the movement control and the mechanisms underlying learning and adapting to the condition of weightlessness. Specifically, i) investigators will determine if a change in the level of gravity is taken into account when controlling grip force and ii) investigators will examine the effects of gravity change on hand-eye coordination.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Other: Parabolic flight
  • Other: movements of the upper limb, the gripping force, muscle activity and eye-cephalic subject movement measurements
Study Arms  ICMJE Dexterity, Coordination,Perception measurements
Dexterity, Hand-eye Coordination and Perception of Orientation and Distances
Interventions:
  • Other: Parabolic flight
  • Other: movements of the upper limb, the gripping force, muscle activity and eye-cephalic subject movement measurements
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 28, 2015)
90
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers, male or female
  • 18 to 65 years
  • Affiliated with a Social Security plan or holder of a European Health Insurance Card (EHIC - European Health Insurance Card - EHIC).
  • Having an aeronautical medical certificate of fitness for flight personnel unprofessional functions in civil aviation.
  • Agreeing to participate in the study
  • Having given informed consent

Exclusion Criteria:

  • person not affiliated to a Social Security Inssurance,
  • person who participated in a clinical trial within the trial below the exclusion period,
  • person with a medical history or any acute or chronic condition that can affect the test results, or by running a risk on during the protocol, especially topics: past or present history of neurological disease, rheumatologic or otologic (hearing or equilibration) OR person with a corrected visual acuity of less than 5 / 10th.
  • pregnant women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563249
Other Study ID Numbers  ICMJE 12-026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Caen
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Caen
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP