Validation of Methods for Evaluating Operation Force, Motion and Visual Perception in Weightlessness

Healthy Volunteers Clinical Trial

— HopMot  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02508558
• Other study ID #: 14-102
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2015
• Last updated: July 23, 2015
• Start date: September 2014
• Est. completion date: November 2017

Study information

• Verified date: July 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

• Pregnant women

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• motion perception and locomotor operation performance measurements

• parabolic flight

Locations

Country	Name	City	State
France	Umr Ucbn/Inserm U1075 Comete	Caen CEDEX	Basse-Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No