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Wearable Robotic Upper Body Exoskeleton for Workers (Exo4Work)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491501
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Romain Meeusen, Vrije Universiteit Brussel

Brief Summary:
The main aim of the project is to evaluate a novel upper body exoskeleton during simulated industrial work. In a first stage of the project, an extensive study involving the end-user companies will be carried out to clearly identify the operator target tasks and typical target task loads for which the exoskeleton will be designed. Based on standard ergonomic evaluation scales (RULA and NIOSH, the Need for Recovery Scale and the Ovako Working Posture Analysing System), high risk tasks will be identified in the field, based on the evaluated information about the workspace configuration, the performed operations and their physical constraints. These will include, but will not be limited to, non-ergonomic postures, for example performing operations above the head or reaching in front, to the side, 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.

Condition or disease Intervention/treatment
Work-Related Condition Physical Stress Mental Fatigue Other: Ergonomic evaluation using questionnaires

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ergonomic Evaluation of Workspaces and Occupational Tasks Targeted for Exoskeleton Support and Definition of Case Studies
Estimated Study Start Date : July 16, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ergonomics

Group/Cohort Intervention/treatment
Industrial employees
Ergonomic evaluation using questionnaires in different Industrial settings will be conducted and thus Industrial employees form the included subject group.
Other: Ergonomic evaluation using questionnaires
Employees will be provided with questionnaires such as the 'Rapid Entire Body Assessment' and NIOSH to obtain information regarding ergonomic working situations




Primary Outcome Measures :
  1. Questionnaire [ Time Frame: The time point of data collection: An average of 1yr ]
    Ergonomic evaluation Industrial work situations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Employees of different companies. Only companies involved in the project will be visited.
Criteria

Inclusion Criteria: Industrial employees

-

Exclusion Criteria:

  • non-able bodied individuals

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491501


Contacts
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Contact: Sander De Bock, Master 0032 2 629 22 22 Sander.De.Bock@vub.be

Locations
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Belgium
Vrije Universiteit Brussel
Brussel, Vlaams Brabant, Belgium, 1050
Sponsors and Collaborators
Vrije Universiteit Brussel

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Responsible Party: Romain Meeusen, Prof. Dr., Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT03491501    
Other Study ID Numbers: S000118N
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data of the questionnaires will be shared within the consortium of the project, mainly between sport scientists involved in the project.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data sharing will take place during the experimental process until December 2018.
Access Criteria: Access to data is only possible if partner in the consortium

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Romain Meeusen, Vrije Universiteit Brussel:
Industrial work
physical effort
mental effort
questionnaires
ergonomic evaluation
Additional relevant MeSH terms:
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Fatigue
Mental Fatigue
Signs and Symptoms
Behavioral Symptoms