NCT02508558

Brief Summary

Previous studies have neglected two important aspects for the China National Space Administration. First, while biomechanical models are very sensitive to the characteristics of the subjects, data have been collected on subjects with biomechanical characteristics very different from those of "typical" Chinese astronauts. Second, pure video analysis techniques and kinematic data lack the necessary acceleration information important to understanding the forces exerted during movement and control of human motion. While some studies used force and moment sensors to aid in robot torque control and human joint work estimation, investigators are unaware of any studies performed in a microgravity environment that have combined the kinetic force and moment information with acceleration measurements to enable more reliable motion tracking without the need for acceleration estimation. This is why MICR0-G sensors and accompanying kinematic video system have been developed in order to provide for detailed analyses of the astronaut movement control strategy (joint forces and torques, kinetic and acceleration measurements). Knowledge of the joint torques permits us to calculate the joint and musculoskeletal dynamics required to execute the microgravity motions, as well to provide insight into the altered movement strategies in reduced gravity as compared to 1-G locomotion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2014

Longer than P75 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

September 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

3.2 years

First QC Date

July 21, 2015

Last Update Submit

July 23, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • motion perception performance under different gravity states

    MICR0-G sensors and accompanying kinematic video system analyses of the astronaut movement control strategy (joint forces and torques, kinetic and acceleration measurements).

    baseline

  • locomotor operation performance under different gravity states

    MICR0-G sensors and accompanying kinematic video system analyses of the astronaut movement control strategy (joint forces and torques, kinetic and acceleration measurements).

    baseline

Study Arms (1)

Measurements under different gravity states

OTHER

motion perception and locomotor operation performance under different gravity states

Other: motion perception and locomotor operation performance measurementsOther: parabolic flight

Interventions

Measurements under different gravity states
Measurements under different gravity states

Eligibility Criteria

Age22 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Chinese volunteers (men or women)
  • Living in France and affiliated to a French Social Security system
  • Aged from 22 to 45
  • Body Mass Index from 19 to 25
  • Who accepted to take part in the study
  • Who has 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

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 21, 2015

First Posted

July 27, 2015

Study Start

September 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

July 27, 2015

Record last verified: 2015-07

Locations