- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04721392
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
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.
|
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
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
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)
March 8, 2021
Primary Completion (Actual)
August 14, 2021
Study Completion (Actual)
August 14, 2021
Study Registration Dates
First Submitted
September 22, 2020
First Submitted That Met QC Criteria
January 19, 2021
First Posted (Actual)
January 22, 2021
Study Record Updates
Last Update Posted (Actual)
October 22, 2021
Last Update Submitted That Met QC Criteria
October 19, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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