Back to resultsThe Effect of a Passive Shoulder Exoskeleton and Muscle Fatigue on Occupational Work Performance
Primary Purpose
Fatigue, Muscle Strain, Physical Stress
Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Passive shoulder exoskeleton
Fatigue protocol
No exoskeleton support
No peripheral fatiguing protocol
Sponsored by
About this trial
This is an interventional prevention trial for Fatigue focused on measuring peripheral fatigue, overhead work, task performance, ergonomics, effort
Eligibility Criteria
Inclusion Criteria:
- healthy (based on ParQ questionnaire)
- right handed
Exclusion Criteria:
- current musculoskeletal disorder
- history of recurrent musculoskeletal discorder
Sites / Locations
- Lichamelijk Opvoeding en Kinesitherapie
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Peripheral fatigue - No support
Peripheral fatigue - Exoskeleton support
No fatigue - No support
No fatigue - Exoskeleton support
Arm Description
peripheral fatigue induced and overhead work performed without exoskeleton support
peripheral fatigue induced and overhead work performed with exoskeleton support
peripheral fatigue induced and overhead work performed without exoskeleton support
peripheral fatigue induced and overhead work performed with exoskeleton support
Outcomes
Primary Outcome Measures
Work accuracy
The number of errors is tracked
Work pace
Time to completion is tracked
Secondary Outcome Measures
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.
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.
Workload
NASA TLX questionnaire for workload
Full Information
NCT ID
NCT05389384
First Posted
April 26, 2021
Last Updated
May 19, 2022
Sponsor
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT05389384
Brief Title
The Effect of a Passive Shoulder Exoskeleton and Muscle Fatigue on Occupational Work Performance
Official Title
The Effect of a Passive Shoulder Exoskeleton and Muscle Fatigue on Occupational Work Performance
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Muscle Strain, Physical Stress
Keywords
peripheral fatigue, overhead work, task performance, ergonomics, effort
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
counterbalanced randomized cross-over study
Masking
Participant
Masking Description
The support of the exoskeleton is concealed. The support will be 'no support' or 'support'.
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peripheral fatigue - No support
Arm Type
Experimental
Arm Description
peripheral fatigue induced and overhead work performed without exoskeleton support
Arm Title
Peripheral fatigue - Exoskeleton support
Arm Type
Experimental
Arm Description
peripheral fatigue induced and overhead work performed with exoskeleton support
Arm Title
No fatigue - No support
Arm Type
Experimental
Arm Description
peripheral fatigue induced and overhead work performed without exoskeleton support
Arm Title
No fatigue - Exoskeleton support
Arm Type
Experimental
Arm Description
peripheral fatigue induced and overhead work performed with exoskeleton support
Intervention Type
Device
Intervention Name(s)
Passive shoulder exoskeleton
Intervention Description
Participants complete overhead working task with support of exo
Intervention Type
Behavioral
Intervention Name(s)
Fatigue protocol
Intervention Description
Participants complete a fatiguing protocol
Intervention Type
Device
Intervention Name(s)
No exoskeleton support
Intervention Description
Exoskeleton is worn, but no support provided
Intervention Type
Behavioral
Intervention Name(s)
No peripheral fatiguing protocol
Intervention Description
Participants complete no fatiguing protocol
Primary Outcome Measure Information:
Title
Work accuracy
Description
The number of errors is tracked
Time Frame
During 2 minutes overhead work
Title
Work pace
Description
Time to completion is tracked
Time Frame
During 2 minutes overhead work
Secondary Outcome Measure Information:
Title
Surface electromyography
Description
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.
Time Frame
During 2 minutes overhead work
Title
Kinematic smoothness of movement
Description
Inetrial Measurement Units will be used to track how smoothly the overhead work is completed. Smoothness is determined by the Spectral Arc method.
Time Frame
During 2 minutes overhead work
Title
Workload
Description
NASA TLX questionnaire for workload
Time Frame
After 2 minutes of overhead work
Other Pre-specified Outcome Measures:
Title
Force output
Description
measure output force during elevation of the arms in a 45° flexed shoulder angle
Time Frame
before and after 4 minute during fatigue inducing protocol
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy (based on ParQ questionnaire)
right handed
Exclusion Criteria:
current musculoskeletal disorder
history of recurrent musculoskeletal discorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain Meeusen, PhD
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lichamelijk Opvoeding en Kinesitherapie
City
Brussel
ZIP/Postal Code
1050
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be published in scientific journal. No IPD will be published.
Learn more about this trial
The Effect of a Passive Shoulder Exoskeleton and Muscle Fatigue on Occupational Work Performance
We'll reach out to this number within 24 hrs