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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05389384
Other study ID # 2021_E4W_SH_PER
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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