Brief 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.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

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

3.8 years study duration

First Submitted

Initial submission to the registry

May 11, 2018

Completed

2 months until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed

9 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed

Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

3.3 years

First QC Date

May 11, 2018

Last Update Submit

January 25, 2021

Conditions

Keywords

Fatigue MentalFatigue Signs and SymptomsBehavioral SymptomsIndustrial workphysical effortmental effortquestionnairesergonomic evaluation

Outcome Measures

Primary Outcomes (1)

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 Outcomes (4)

EEG: changes in event related potentials during cognitive Stroop task (change in mental fatigue: physiological component)
Measuring EEG during Stroop tasks (10 minutes) before and after each 90 minute task
Change in mental fatigue (behavioral component: part 1)
Measuring reaction time during Stroop tasks (10 minutes) before and after each 90 minute task
Change in mental fatigue (behavioral component: part 2)
Measuring accuracy during Stroop tasks (10 minutes) before and after each 90 minute task
Change in mental fatigue (subjective component)
Before and after each 90 minute task subjective questionnaire will be filled out