Mental Fatigue and Industrial Work Performance

October 19, 2021 updated by: Romain Meeusen, Vrije Universiteit Brussel

Mental Fatigue and Industrial Work Performance: The Influence of the Laevo Exoskeleton

To investigate the effect of mental fatigue on industrial work performance, biomechanical determinants, (electro-)(psycho-) physiological measures and physical ergonomics. Additionally, the current project wants to evaluate whether or not the Laevo exoskeleton influences the aforementioned parameters when mental fatigue is acutely induced.

Study Overview

Status

Status

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

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 (Actual)

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.
12

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 Locations

  • Belgium
    • Brussel
      • Etterbeek, Brussel, Belgium, 1050
        • Vrije Universiteit Brussel

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 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • Males and Females
  • 18-64 years

Exclusion Criteria:

  • Musculoskeletal disorders
  • Neurological disorders
  • Cardiovascular disorders
  • Pregnancy

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: Prevention
  • 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: Mental fatigue - No Robot
During a 15 minute trial, the participant will relocate a box of 5 kilograms between ground level and shoulder height. During this task, the participants are asked to perform the serial seven task, continuously subtracting seven from a given number between 900 and 950. Afterwards, the participant will perform a 60- minute Stroop task and is asked to repeat this abovementioned physical dual-task.
Other: Mental fatigue (Stroop task)
A modified Stroop task of approximately 60 min will be used in order to induce mental fatigue (MF). This will be based on their performance during the max test that was conducted during the familiarization session. In this task, which will be partitioned in 4 blocks of 468 stimuli, four colored words ("rood", "blauw", "groen" and "geel") will be presented one at a time on a computer screen. The participants will be required to indicate the color of the word, ignoring the meaning of the word itself.
Experimental: Mental fatigue - Exoskeleton
During a 15 minute trial, the participant will wear the Laevo exoskeleton and will relocate a box of 5 kilograms between ground level and shoulder height. During this task, the participants are asked to perform the serial seven task, continuously subtracting seven from a given number between 900 and 950. Afterwards, the participant will perform a 60- minute Stroop task and is asked to repeat this abovementioned physical dual-task.
Other: Mental fatigue (Stroop task)
A modified Stroop task of approximately 60 min will be used in order to induce mental fatigue (MF). This will be based on their performance during the max test that was conducted during the familiarization session. In this task, which will be partitioned in 4 blocks of 468 stimuli, four colored words ("rood", "blauw", "groen" and "geel") will be presented one at a time on a computer screen. The participants will be required to indicate the color of the word, ignoring the meaning of the word itself.
Placebo Comparator: No Mental fatigue - No Robot
During a 15 minute trial, the participant will relocate a box of 5 kilograms between ground level and shoulder height. During this task, the participants are asked to perform the serial seven task, continuously subtracting seven from a given number between 900 and 950. Afterwards, the participant will watch a 60- minute neutral documentary and is asked to repeat this abovementioned physical dual-task.
Other: Control (documentary)
In the control task subjects will have to watch a documentary of 60 min on the same computer screen as the one used for the experimental trial. In order to avoid under- and over-arousal the subjects will have the opportunity to choose between several documentaries as proposed by the research team.
Placebo Comparator: No Mental fatigue - Exoskeleton
During a 15 minute trial, the participant will wear the Laevo exoskeleton and will relocate a box of 5 kilograms between ground level and shoulder height. During this task, the participants are asked to perform the serial seven task, continuously subtracting seven from a given number between 900 and 950. Afterwards, the participant will watch a 60- minute neutral documentary and is asked to repeat this abovementioned physical dual-task.
Other: Control (documentary)
In the control task subjects will have to watch a documentary of 60 min on the same computer screen as the one used for the experimental trial. In order to avoid under- and over-arousal the subjects will have the opportunity to choose between several documentaries as proposed by the research team.

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
VICON: Placement accuracy Box
Time Frame: 30 minutes
Accuracy of placement box during the dual-task will be measured with VICON. VICON-markers will be placed on the box to track its movement during the trial. First, the optimal position of the box for each level (ground or shoulder) will be determined, these will form the reference frames. Next, the accuracy of each relocation will be determined by the offset compared to these reference frames. This will be calculated into a percentage.
30 minutes
Work performance: Percent accuracy Serial Seven Task
Time Frame: 30 minutes
An audio record of this task will be made to verify made errors posthoc. During the serial seven task participants are given a number between 900 and 950. The given starting number will change each trial. Participants are asked to subsequently subtract seven as fast as possible.The researcher will take note of every answer. If the participant makes an error, he/she may continue to calculate with the wrong number. The ratio of correct answers to the total number of responses will indicate the percent accuracy for each participant.
30 minutes
Ergonomics: EMG-data
Time Frame: 30 minutes
Muscle activity during the performance of the industrial task of the erector spinae muscle, m. rectus abdominus, both m. obliqui abdominus, all three parts of m. trapezius, all three of m. deltoideus, m. pectoralis major, m. latissimus dorsi, m. biceps brachii, m. triceps brachii,m. flexor- and extensor carpi radials, m. flexor- and extensor carpi ulnaris, m. flexor- and extensor digitorum, m. gluteus maximus and medius, m. rectus femoris, m. biceps femoris. ; measured with Cometa mini wave.
30 minutes
Ergonomics: Joint angles
Time Frame: 30 minutes
Joint angles will be measured during the performance of the industrial task to evaluate movement variability. 30 VICON markers will be placed bilateral on the body of the participant on anatomical landmarks.
30 minutes
Mental fatigue: EEG-data
Time Frame: 60 minutes
Alpha, Beta and Theta activity in the electroencephalogram measured with open bci (OpenBci, inc)
60 minutes
Mental fatigue: VAS-score
Time Frame: 60 minutes
Participants are asked to indicate their subjective feeling on a straight line ranging from "not at all mentally fatigued" to "extreme mentally fatigued"
60 minutes

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

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.
March 8, 2021

Primary Completion (Actual)

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.
August 14, 2021

Study Completion (Actual)

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.
August 14, 2021

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).
September 22, 2020

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.
January 19, 2021

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.
January 22, 2021

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.
October 22, 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.
October 19, 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.
October 1, 2021

More Information

Terms related to this study

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.
  • MF-Industrial Work

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.

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