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Mental Fatigue and Industrial Work Performance

Primary Purpose

Healthy, Mental Fatigue, Industrial Work

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mental fatigue (Stroop task)
Control (documentary)
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy
  • Males and Females
  • 18-64 years

Exclusion Criteria:

  • Musculoskeletal disorders
  • Neurological disorders
  • Cardiovascular disorders
  • Pregnancy

Sites / Locations

  • Vrije Universiteit Brussel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Mental fatigue - No Robot

Mental fatigue - Exoskeleton

No Mental fatigue - No Robot

No Mental fatigue - Exoskeleton

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Mental fatigue: EEG-data
Alpha, Beta and Theta activity in the electroencephalogram measured with open bci (OpenBci, inc)
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"

Secondary Outcome Measures

Full Information

First Posted
September 22, 2020
Last Updated
October 19, 2021
Sponsor
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04721392
Brief Title
Mental Fatigue and Industrial Work Performance
Official Title
Mental Fatigue and Industrial Work Performance: The Influence of the Laevo Exoskeleton
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
August 14, 2021 (Actual)
Study Completion Date
August 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Mental Fatigue, Industrial Work, Robotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mental fatigue - No Robot
Arm Type
Experimental
Arm Description
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.
Arm Title
Mental fatigue - Exoskeleton
Arm Type
Experimental
Arm Description
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.
Arm Title
No Mental fatigue - No Robot
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
No Mental fatigue - Exoskeleton
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mental fatigue (Stroop task)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control (documentary)
Intervention Description
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.
Primary Outcome Measure Information:
Title
VICON: Placement accuracy Box
Description
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.
Time Frame
30 minutes
Title
Work performance: Percent accuracy Serial Seven Task
Description
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.
Time Frame
30 minutes
Title
Ergonomics: EMG-data
Description
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.
Time Frame
30 minutes
Title
Ergonomics: Joint angles
Description
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.
Time Frame
30 minutes
Title
Mental fatigue: EEG-data
Description
Alpha, Beta and Theta activity in the electroencephalogram measured with open bci (OpenBci, inc)
Time Frame
60 minutes
Title
Mental fatigue: VAS-score
Description
Participants are asked to indicate their subjective feeling on a straight line ranging from "not at all mentally fatigued" to "extreme mentally fatigued"
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Males and Females 18-64 years Exclusion Criteria: Musculoskeletal disorders Neurological disorders Cardiovascular disorders Pregnancy
Facility Information:
Facility Name
Vrije Universiteit Brussel
City
Etterbeek
State/Province
Brussel
ZIP/Postal Code
1050
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Mental Fatigue and Industrial Work Performance

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