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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05389384
• Other study ID #: 2021_E4W_SH_PER
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy (based on ParQ questionnaire)

• right handed

Exclusion Criteria:

• current musculoskeletal disorder

• history of recurrent musculoskeletal discorder

Related Conditions & MeSH terms

• Fatigue
• Muscle Strain
• Physical Stress

Intervention

Device:
• Passive shoulder exoskeleton
Participants complete overhead working task with support of exo

Behavioral:
• Fatigue protocol
Participants complete a fatiguing protocol

Device:
• No exoskeleton support
Exoskeleton is worn, but no support provided

Behavioral:
• No peripheral fatiguing protocol
Participants complete no fatiguing protocol

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
Other	Force output	measure output force during elevation of the arms in a 45° flexed shoulder angle	before and after 4 minute during fatigue inducing protocol
Primary	Work accuracy	The number of errors is tracked	During 2 minutes overhead work
Primary	Work pace	Time to completion is tracked	During 2 minutes overhead work
Secondary	Surface electromyography	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
Secondary	Kinematic smoothness of movement	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
Secondary	Workload	NASA TLX questionnaire for workload	After 2 minutes of overhead work