The Effect of a Passive Shoulder Exoskeleton and Muscle Fatigue on Occupational Work Performance

May 19, 2022 updated by: Romain Meeusen, Vrije Universiteit Brussel
In this investigation, participants perform simulated occupational work during which the task performance will be logged. This research investigates the effect of peripheral fatigue and a passive shoulder exoskeleton on the task performance.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussel, Belgium, 1050
        • Lichamelijk Opvoeding en Kinesitherapie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy (based on ParQ questionnaire)
  • right handed

Exclusion Criteria:

  • current musculoskeletal disorder
  • history of recurrent musculoskeletal discorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peripheral fatigue - No support
peripheral fatigue induced and overhead work performed without exoskeleton support
Participants complete a fatiguing protocol
Exoskeleton is worn, but no support provided
Experimental: Peripheral fatigue - Exoskeleton support
peripheral fatigue induced and overhead work performed with exoskeleton support
Participants complete a fatiguing protocol
Participants complete overhead working task with support of exo
Experimental: No fatigue - No support
peripheral fatigue induced and overhead work performed without exoskeleton support
Exoskeleton is worn, but no support provided
Participants complete no fatiguing protocol
Experimental: No fatigue - Exoskeleton support
peripheral fatigue induced and overhead work performed with exoskeleton support
Participants complete overhead working task with support of exo
Participants complete no fatiguing protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work accuracy
Time Frame: During 2 minutes overhead work
The number of errors is tracked
During 2 minutes overhead work
Work pace
Time Frame: During 2 minutes overhead work
Time to completion is tracked
During 2 minutes overhead work

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface electromyography
Time Frame: During 2 minutes overhead work
Cometa (Mini Wave) sensors with Ambu (BlueSensor) electrodes will be used to collect electromyographic data conform the SENIAM guidelines. The muscles that will be monitored are: deltoideus anterior, deltoideus medialis, deltoideus posterior, pectoralis major, latissimus dorsi, brachioradialis, biceps brachii, triceps brachii, trapezius descendens, infraspinatus, supraspinatus, flexor carpi radialis, serratus anterior on the right side of the body. The locations of the sensors will be prepared by shaving, abrasion with sandpaper and cleaning with alcohol. To allow relative expression of muscle activity, maximal voluntary contractions (MVC) of each muscle that is being monitored will be collected. The average of the maximal activity out of the best two out of three contractions will serve as the MVC value. The outcomes will be the activities of the muscles (as a percentage of the MVC) monitored during the tests.
During 2 minutes overhead work
Kinematic smoothness of movement
Time Frame: During 2 minutes overhead work
Inetrial Measurement Units will be used to track how smoothly the overhead work is completed. Smoothness is determined by the Spectral Arc method.
During 2 minutes overhead work
Workload
Time Frame: After 2 minutes of overhead work
NASA TLX questionnaire for workload
After 2 minutes of overhead work

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Force output
Time Frame: before and after 4 minute during fatigue inducing protocol
measure output force during elevation of the arms in a 45° flexed shoulder angle
before and after 4 minute during fatigue inducing protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Romain Meeusen, PhD, Vrije Universiteit Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021_E4W_SH_PER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be published in scientific journal. No IPD will be published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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