- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05389384
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
Status
Active, not recruiting
Conditions
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
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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
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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
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NASA TLX questionnaire for workload
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After 2 minutes of overhead work
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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.
Sponsor
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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