FatigueNCT05389384
The Effect of a Passive Shoulder Exoskeleton and Muscle Fatigue on Occupational Work Performance
A study testing Passive shoulder exoskeleton, Fatigue protocol and No exoskeleton support in people with Fatigue and Muscle Strain, run by Vrije Universiteit Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Muscle Strain, Physical Stress
- What is being tested?
- Passive shoulder exoskeleton, Fatigue protocol and No exoskeleton support
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Aug 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy (based on ParQ questionnaire)
- right handed
Who cannot join
- current musculoskeletal disorder
- history of recurrent musculoskeletal discorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fatigue, Muscle Strain, Physical Stress
- Being tested
- Passive shoulder exoskeleton, Fatigue protocol, No exoskeleton support, No peripheral fatiguing protocol
- Keywords
- peripheral fatigue, overhead work, task performance, ergonomics, effort
- Medical subject headings
- Fatigue, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive shoulder exoskeletonDevice
Participants complete overhead working task with support of exo
Fatigue protocolBehavioural
Participants complete a fatiguing protocol
No exoskeleton supportDevice
Exoskeleton is worn, but no support provided
No peripheral fatiguing protocolBehavioural
Participants complete no fatiguing protocol
| Study group | Role | What they receive |
|---|---|---|
| Peripheral fatigue - No support | Experimental | peripheral fatigue induced and overhead work performed without exoskeleton support Receives: Behavioral: Fatigue protocol; Device: No exoskeleton support |
| Peripheral fatigue - Exoskeleton support | Experimental | peripheral fatigue induced and overhead work performed with exoskeleton support Receives: Device: Passive shoulder exoskeleton; Behavioral: Fatigue protocol |
| No fatigue - No support | Experimental | peripheral fatigue induced and overhead work performed without exoskeleton support Receives: Device: No exoskeleton support; Behavioral: No peripheral fatiguing protocol |
| No fatigue - Exoskeleton support | Experimental | peripheral fatigue induced and overhead work performed with exoskeleton support Receives: Device: Passive shoulder exoskeleton; Behavioral: No peripheral fatiguing protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work accuracy
The number of errors is tracked
Measured: During 2 minutes overhead work
Work pace
Time to completion is tracked
Measured: During 2 minutes overhead work
Secondary outcomes (3)
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.
Measured: During 2 minutes overhead work
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.
Measured: During 2 minutes overhead work
Workload
NASA TLX questionnaire for workload
Measured: After 2 minutes of overhead work
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start20 Aug 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- counterbalanced randomized cross-over study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Meeusen, Vrije Universiteit Brussel
- Investigators
- Romain Meeusen, PhD, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389384
- Sponsor's protocol ID
- 2021_E4W_SH_PER
- Status last verified
- May 2022
- First submitted
- 26 Apr 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published in scientific journal. No IPD will be published.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Passive Shoulder Exoskeleton and Muscle Fatigue on Occupational Work Performance
- ClinicalTrials.gov ID
- NCT05389384
- Acronym / sponsor ID
- 2021_E4W_SH_PER
- Conditions
- Fatigue, Muscle Strain, Physical Stress
- Keywords
- peripheral fatigue, overhead work, task performance, ergonomics, effort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- counterbalanced randomized cross-over study
| Arm | Type | Receives |
|---|---|---|
| Peripheral fatigue - No support | Experimental | Behavioral: Fatigue protocol, Device: No exoskeleton supportperipheral fatigue induced and overhead work performed without exoskeleton support |
| Peripheral fatigue - Exoskeleton support | Experimental | Device: Passive shoulder exoskeleton, Behavioral: Fatigue protocolperipheral fatigue induced and overhead work performed with exoskeleton support |
| No fatigue - No support | Experimental | Device: No exoskeleton support, Behavioral: No peripheral fatiguing protocolperipheral fatigue induced and overhead work performed without exoskeleton support |
| No fatigue - Exoskeleton support | Experimental | Device: Passive shoulder exoskeleton, Behavioral: No peripheral fatiguing protocolperipheral fatigue induced and overhead work performed with exoskeleton support |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy (based on ParQ questionnaire)
- right handed
Key exclusion criteria (2 listed)
- current musculoskeletal disorder
- history of recurrent musculoskeletal discorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive shoulder exoskeletonParticipants complete overhead working task with support of exo | Device | No fatigue - Exoskeleton support, Peripheral fatigue - Exoskeleton support |
| Fatigue protocolParticipants complete a fatiguing protocol | Behavioural | Peripheral fatigue - Exoskeleton support, Peripheral fatigue - No support |
| No exoskeleton supportExoskeleton is worn, but no support provided | Device | No fatigue - No support, Peripheral fatigue - No support |
| No peripheral fatiguing protocolParticipants complete no fatiguing protocol | Behavioural | No fatigue - Exoskeleton support, No fatigue - No support |
Primary outcome
Work accuracy
Time frame: During 2 minutes overhead work
The number of errors is tracked
Work pace
Time frame: During 2 minutes overhead work
Time to completion is tracked
3 secondary outcomes
Surface electromyography
Time frame: During 2 minutes overhead work
Kinematic smoothness of movement
Time frame: During 2 minutes overhead work
Workload
Time frame: After 2 minutes of overhead work
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No. Data will be published in scientific journal. No IPD will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain Meeusen, PhD principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive shoulder exoskeleton, Fatigue protocol and No exoskeleton support in people with Fatigue and Muscle Strain, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work accuracy (time frame: During 2 minutes overhead work). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.