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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04721392
Other study ID # MF-Industrial Work
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 8, 2021
Est. completion date August 14, 2021

Study information

Verified date October 2021
Source Vrije Universiteit Brussel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date August 14, 2021
Est. primary completion date August 14, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Healthy - Males and Females - 18-64 years Exclusion Criteria: - Musculoskeletal disorders - Neurological disorders - Cardiovascular disorders - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Belgium Vrije Universiteit Brussel Etterbeek Brussel

Sponsors (1)

Lead Sponsor Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary VICON: Placement accuracy Box 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
Primary Work performance: Percent accuracy Serial Seven Task 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
Primary Ergonomics: EMG-data 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
Primary Ergonomics: Joint angles 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
Primary Mental fatigue: EEG-data Alpha, Beta and Theta activity in the electroencephalogram measured with open bci (OpenBci, inc) 60 minutes
Primary Mental fatigue: VAS-score 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
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