NCT03491501

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.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

March 30, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

March 30, 2018

Last Update Submit

May 11, 2018

Conditions

Keywords

Industrial workphysical effortmental effortquestionnairesergonomic evaluation

Outcome Measures

Primary Outcomes (1)

  • Questionnaire

    Ergonomic evaluation Industrial work situations

    The time point of data collection: An average of 1yr

Study Arms (1)

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

Interventions

Employees will be provided with questionnaires such as the 'Rapid Entire Body Assessment' and NIOSH to obtain information regarding ergonomic working situations

Industrial employees

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Employees of different companies. Only companies involved in the project will be visited.

You may not qualify if:

  • non-able bodied individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Brussels, Vlaams Brabant, 1050, Belgium

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Central Study Contacts

Sander De Bock, Master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 30, 2018

First Posted

April 9, 2018

Study Start

July 16, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 14, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Data of the questionnaires will be shared within the consortium of the project, mainly between sport scientists involved in the project.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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

Locations