Work-Related ConditionExo4WorkNCT03491501
Wearable Robotic Upper Body Exoskeleton for Workers
An observational study of Work-Related Condition and Physical Stress, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Work-Related Condition, Physical Stress, Mental Fatigue
- What is being tested?
- Ergonomic evaluation using questionnaires
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Jul 2018to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Employees of different companies. Only companies involved in the project will be visited.
Who may be able to join
- -
Who cannot join
- non-able bodied individuals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ergonomic Evaluation of Workspaces and Occupational Tasks Targeted for Exoskeleton Support and Definition of Case Studies
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.
- Conditions
- Work-Related Condition, Physical Stress, Mental Fatigue
- Being tested
- Ergonomic evaluation using questionnaires
- Keywords
- Industrial work, physical effort, mental effort, questionnaires, ergonomic evaluation
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic evaluation using questionnairesOther
Employees will be provided with questionnaires such as the 'Rapid Entire Body Assessment' and NIOSH to obtain information regarding ergonomic working situations
| Study group | Role | What they receive |
|---|---|---|
| Industrial employees | Ergonomic evaluation using questionnaires in different Industrial settings will be conducted and thus Industrial employees form the included subject group. Receives: Other: Ergonomic evaluation using questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
Ergonomic evaluation Industrial work situations
Measured: The time point of data collection: An average of 1yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start16 Jul 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-Related ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Meeusen, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491501
- Sponsor's protocol ID
- S000118N
- Acronym
- Exo4Work
- Status last verified
- May 2018
- First submitted
- 30 Mar 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data of the questionnaires will be shared within the consortium of the project, mainly between sport scientists involved in the project.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergonomic Evaluation of Workspaces and Occupational Tasks Targeted for Exoskeleton Support and Definition of Case Studies
- ClinicalTrials.gov ID
- NCT03491501
- Acronym / sponsor ID
- Exo4Work / S000118N
- Conditions
- Work-Related Condition, Physical Stress, Mental Fatigue
- Keywords
- Industrial work, physical effort, mental effort, questionnaires, ergonomic evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 16 Jul 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Industrial employees | – | Other: Ergonomic evaluation using questionnairesErgonomic evaluation using questionnaires in different Industrial settings will be conducted and thus Industrial employees form the included subject group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Employees of different companies. Only companies involved in the project will be visited.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- non-able bodied individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergonomic evaluation using questionnairesEmployees will be provided with questionnaires such as the 'Rapid Entire Body Assessment' and NIOSH to obtain information regarding ergonomic working situations | Other | Industrial employees |
Primary outcome
Questionnaire
Time frame: The time point of data collection: An average of 1yr
Ergonomic evaluation Industrial work situations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Individual participant dataSharing planned: Yes. Data of the questionnaires will be shared within the consortium of the project, mainly between sport scientists involved in the project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work-Related Condition and Physical Stress, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sander De Bock, Master (0032 2 629 22 22, Sander.De.Bock@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: The time point of data collection: An average of 1yr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.