Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-28 @ 6:47 PM
Study NCT ID:
NCT02508558
Status:
UNKNOWN
Last Update Posted:
2015-07-27
First Post:
2015-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Methods for Evaluating Operation Force, Motion and Visual Perception in Weightlessness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-23', 'studyFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2015-07-23', 'lastUpdatePostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'motion perception performance under different gravity states', 'timeFrame': 'baseline', 'description': 'MICR0-G sensors and accompanying kinematic video system analyses of the astronaut movement control strategy (joint forces and torques, kinetic and acceleration measurements).'}, {'measure': 'locomotor operation performance under different gravity states', 'timeFrame': 'baseline', 'description': 'MICR0-G sensors and accompanying kinematic video system analyses of the astronaut movement control strategy (joint forces and torques, kinetic and acceleration measurements).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Chinese volunteers (men or women)\n* Living in France and affiliated to a French Social Security system\n* Aged from 22 to 45\n* Body Mass Index from 19 to 25\n* Who accepted to take part in the study\n* Who has given their written stated consent\n* 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\n\nExclusion Criteria:\n\n* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT02508558', 'acronym': 'HopMot', 'briefTitle': 'Validation of Methods for Evaluating Operation Force, Motion and Visual Perception in Weightlessness', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'orgStudyIdInfo': {'id': '14-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Measurements under different gravity states', 'description': 'motion perception and locomotor operation performance under different gravity states', 'interventionNames': ['Other: motion perception and locomotor operation performance measurements', 'Other: parabolic flight']}], 'interventions': [{'name': 'motion perception and locomotor operation performance measurements', 'type': 'OTHER', 'armGroupLabels': ['Measurements under different gravity states']}, {'name': 'parabolic flight', 'type': 'OTHER', 'armGroupLabels': ['Measurements under different gravity states']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14032', 'city': 'Caen', 'state': 'Basse-Normandie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Denise, MD PhD', 'role': 'CONTACT', 'email': 'pierre.denise@unicaen.fr', 'phone': '332068214'}], 'facility': 'Umr Ucbn/Inserm U1075 Comete', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}