NCT04721392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2021

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

September 22, 2020

Last Update Submit

October 19, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • Mental fatigue: EEG-data

    Alpha, Beta and Theta activity in the electroencephalogram measured with open bci (OpenBci, inc)

    60 minutes

  • 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

Study Arms (4)

Mental fatigue - No Robot

EXPERIMENTAL

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)

Mental fatigue - Exoskeleton

EXPERIMENTAL

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)

No Mental fatigue - No Robot

PLACEBO COMPARATOR

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)

No Mental fatigue - Exoskeleton

PLACEBO COMPARATOR

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)

Interventions

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.

Mental fatigue - ExoskeletonMental fatigue - No Robot

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.

No Mental fatigue - ExoskeletonNo Mental fatigue - No Robot

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Males and Females
  • years

You may not qualify if:

  • Musculoskeletal disorders
  • Neurological disorders
  • Cardiovascular disorders
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Brussel

Etterbeek, Brussels Capital, 1050, Belgium

Location

MeSH Terms

Conditions

Mental Fatigue

Interventions

Stroop Test

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 22, 2020

First Posted

January 22, 2021

Study Start

March 8, 2021

Primary Completion

August 14, 2021

Study Completion

August 14, 2021

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations