Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT03580304
Status:
UNKNOWN
Last Update Posted:
2021-01-26
First Post:
2018-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Physical and Cognitive Industrial Workload
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}], 'ancestors': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-11', 'size': 342702, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-12T04:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2018-05-11', 'studyFirstSubmitQcDate': '2018-06-25', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG: change in power spectral density (change in mental fatigue: physiological component)', 'timeFrame': 'Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task', 'description': 'The power of different frequency bands during a cognitive Stroop task will be compared PRE vs POST 90 minute task and differences between different tasks will be analysed.'}], 'secondaryOutcomes': [{'measure': 'EEG: changes in event related potentials during cognitive Stroop task (change in mental fatigue: physiological component)', 'timeFrame': 'Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task', 'description': 'Event related potentials during cognitive Stroop task will be compared PRE vs POST 90 minute task and differences between different tasks will be analysed.'}, {'measure': 'Change in mental fatigue (behavioral component: part 1)', 'timeFrame': 'Measuring reaction time during Stroop tasks (10 minutes) before and after each 90 minute task', 'description': 'Reaction time during cognitive stroop task'}, {'measure': 'Change in mental fatigue (behavioral component: part 2)', 'timeFrame': 'Measuring accuracy during Stroop tasks (10 minutes) before and after each 90 minute task', 'description': 'Accuracy time during cognitive stroop task'}, {'measure': 'Change in mental fatigue (subjective component)', 'timeFrame': 'Before and after each 90 minute task subjective questionnaire will be filled out', 'description': 'Questionnaire (sRPE) before and after performing each 90 min task'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fatigue Mental', 'Fatigue Signs and Symptoms', 'Behavioral Symptoms', 'Industrial work', 'physical effort', 'mental effort', 'questionnaires', 'ergonomic evaluation'], 'conditions': ['Work-Related Condition', 'Physical Stress', 'Mental Fatigue']}, 'descriptionModule': {'briefSummary': 'The main aim of the project is to evaluate a novel upper body exoskeleton during simulated industrial work. In this stage of the project, a study analysing the physical and mental load during occupational work will be carried out. High risk tasks will be identified in the field and simulated in lab-setting to analyse physical and mental load using physiological and biomechanical data.These will include, but will not be limited to, non-ergonomic postures, for example performing operations above the head or reaching in front of, to the side of, or behind the body; flexing the arms for extended periods of time; and bending or twisting the torso to lift an object from low or distant locations. Important items to assess in this task are the frequency and duration of tasks and activities, lifting characteristics, perceived physical effort and work-induced fatigue.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* 18 - 65 yrs old\n\nExclusion Criteria:\n\n* injury'}, 'identificationModule': {'nctId': 'NCT03580304', 'briefTitle': 'Evaluation of Physical and Cognitive Industrial Workload', 'organization': {'class': 'OTHER', 'fullName': 'Vrije Universiteit Brussel'}, 'officialTitle': 'Evaluation of Mental and Physical Load During Lab-simulated Industrial Work', 'orgStudyIdInfo': {'id': 'S008517N'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'industrial-physical-cognitive', 'interventionNames': ['Behavioral: Industrial work', 'Behavioral: Physical load', 'Behavioral: Cognitive load']}, {'type': 'EXPERIMENTAL', 'label': 'industrial- cognitive-physical', 'interventionNames': ['Behavioral: Industrial work', 'Behavioral: Physical load', 'Behavioral: Cognitive load']}, {'type': 'EXPERIMENTAL', 'label': 'physical- industrial- cognitive', 'interventionNames': ['Behavioral: Industrial work', 'Behavioral: Physical load', 'Behavioral: Cognitive load']}, {'type': 'EXPERIMENTAL', 'label': 'physical-cognitive- industrial', 'interventionNames': ['Behavioral: Industrial work', 'Behavioral: Physical load', 'Behavioral: Cognitive load']}, {'type': 'EXPERIMENTAL', 'label': 'cognitive- industrial-physical', 'interventionNames': ['Behavioral: Industrial work', 'Behavioral: Physical load', 'Behavioral: Cognitive load']}, {'type': 'EXPERIMENTAL', 'label': 'cognitive-physical-industrial', 'interventionNames': ['Behavioral: Industrial work', 'Behavioral: Physical load', 'Behavioral: Cognitive load']}], 'interventions': [{'name': 'Industrial work', 'type': 'BEHAVIORAL', 'description': 'Subjects perform simulated industrial work in lab setting. The industrial task exists of a physical component and a cognitive component. Physical load is measured by questionnaires and basic physiological measurements (e.g. heart rate). Mental fatigue will be determined by questionnaires and a cognitive stroop task before and after the trial.', 'armGroupLabels': ['cognitive- industrial-physical', 'cognitive-physical-industrial', 'industrial- cognitive-physical', 'industrial-physical-cognitive', 'physical- industrial- cognitive', 'physical-cognitive- industrial']}, {'name': 'Physical load', 'type': 'BEHAVIORAL', 'description': 'The physical load of an industrial task will be simulated during this intervention. Physical load is measured by questionnaires and basic physiological measurements (e.g. heart rate). Before and after the trial, mental fatigue will be determined by questionnaires and a cognitive stroop task (10 min)', 'armGroupLabels': ['cognitive- industrial-physical', 'cognitive-physical-industrial', 'industrial- cognitive-physical', 'industrial-physical-cognitive', 'physical- industrial- cognitive', 'physical-cognitive- industrial']}, {'name': 'Cognitive load', 'type': 'BEHAVIORAL', 'description': 'The cognitive load of an industrial task will be simulated in this intervention. Physical load is measured by questionnaires and basic physiological measurements (e.g. heart rate). Before and after the trial, mental fatigue will be determined by questionnaires and a cognitive stroop task (10 min)', 'armGroupLabels': ['cognitive- industrial-physical', 'cognitive-physical-industrial', 'industrial- cognitive-physical', 'industrial-physical-cognitive', 'physical- industrial- cognitive', 'physical-cognitive- industrial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1050', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Lichamelijk Opvoeding en Kinesitherapie', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Sander De Bock', 'role': 'CONTACT', 'email': 'sander.de.bock@vub.be', 'phone': '+32 2 629 22 22'}, {'name': 'Kevin De Pauw, PhD', 'role': 'CONTACT', 'email': 'kevin.de.pauw@vub.be', 'phone': '+32 2 629 22 22'}], 'overallOfficials': [{'name': 'Romain Meeusen, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vrije Universiteit Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Romain Meeusen', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}