Evaluation of Physical and Cognitive Industrial Workload

January 25, 2021 updated by: Romain Meeusen, Vrije Universiteit Brussel

Evaluation of Mental and Physical Load During Lab-simulated Industrial Work

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Brussel, Belgium, 1050
        • Recruiting
        • Lichamelijk Opvoeding en Kinesitherapie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male
  • 18 - 65 yrs old

Exclusion Criteria:

  • injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: industrial-physical-cognitive
Behavioral: Industrial work
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.
Behavioral: Physical load
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)
Behavioral: Cognitive load
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)
Experimental: industrial- cognitive-physical
Behavioral: Industrial work
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.
Behavioral: Physical load
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)
Behavioral: Cognitive load
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)
Experimental: physical- industrial- cognitive
Behavioral: Industrial work
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.
Behavioral: Physical load
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)
Behavioral: Cognitive load
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)
Experimental: physical-cognitive- industrial
Behavioral: Industrial work
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.
Behavioral: Physical load
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)
Behavioral: Cognitive load
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)
Experimental: cognitive- industrial-physical
Behavioral: Industrial work
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.
Behavioral: Physical load
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)
Behavioral: Cognitive load
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)
Experimental: cognitive-physical-industrial
Behavioral: Industrial work
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.
Behavioral: Physical load
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)
Behavioral: Cognitive load
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
EEG: change in power spectral density (change in mental fatigue: physiological component)
Time Frame: Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task
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.
Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
EEG: changes in event related potentials during cognitive Stroop task (change in mental fatigue: physiological component)
Time Frame: Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task
Event related potentials during cognitive Stroop task will be compared PRE vs POST 90 minute task and differences between different tasks will be analysed.
Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task
Change in mental fatigue (behavioral component: part 1)
Time Frame: Measuring reaction time during Stroop tasks (10 minutes) before and after each 90 minute task
Reaction time during cognitive stroop task
Measuring reaction time during Stroop tasks (10 minutes) before and after each 90 minute task
Change in mental fatigue (behavioral component: part 2)
Time Frame: Measuring accuracy during Stroop tasks (10 minutes) before and after each 90 minute task
Accuracy time during cognitive stroop task
Measuring accuracy during Stroop tasks (10 minutes) before and after each 90 minute task
Change in mental fatigue (subjective component)
Time Frame: Before and after each 90 minute task subjective questionnaire will be filled out
Questionnaire (sRPE) before and after performing each 90 min task
Before and after each 90 minute task subjective questionnaire will be filled out

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vrije Universiteit Brussel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Romain Meeusen, Prof. Dr., Vrije Universiteit Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S008517N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings