Evaluation of Physical and Cognitive Industrial Workload

Mental Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03580304
• Other study ID #: S008517N
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2021
• Source: Vrije Universiteit Brussel
• Contact: Sander De Bock
• Phone: +32 2 629 22 22
• Email: sander.de.bock[@]vub.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• male

• 18 - 65 yrs old

Exclusion Criteria:

• injury

Related Conditions & MeSH terms

• Fatigue
• Mental Fatigue
• Physical Stress
• Work-Related Condition

Intervention

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.
• 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)
• 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)

Locations

Country	Name	City	State
Belgium	Lichamelijk Opvoeding en Kinesitherapie	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	EEG: change in power spectral density (change in mental fatigue: physiological component)	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	EEG: changes in event related potentials during cognitive Stroop task (change in mental fatigue: physiological component)	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
Secondary	Change in mental fatigue (behavioral component: part 1)	Reaction time during cognitive stroop task	Measuring reaction time during Stroop tasks (10 minutes) before and after each 90 minute task
Secondary	Change in mental fatigue (behavioral component: part 2)	Accuracy time during cognitive stroop task	Measuring accuracy during Stroop tasks (10 minutes) before and after each 90 minute task
Secondary	Change in mental fatigue (subjective component)	Questionnaire (sRPE) before and after performing each 90 min task	Before and after each 90 minute task subjective questionnaire will be filled out