Exoskeleton DeviceNCT04105101
The Effect of a Novel Passive Shoulder Exoskeleton During Industrial Work
A study testing Industrial passive shoulder exoskeleton in people with Exoskeleton Device, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
After designing a first prototype of next generation industrial exoskeleton, the system should be evaluated in laboratory conditions. In order to evaluate the passive shoulder exoskeleton, designed to assist workers, a protocol is developed in which parts of industrial work is simulated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Exoskeleton Device
- What is being tested?
- Industrial passive shoulder exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Oct 2019to 30 Sep 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy individuals (based on ParQ questionnaire)
Who cannot join
- work related disorders
- shoulder injuries in the past
- back injuries in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Novel Passive Shoulder Exoskeleton on the Human Body During Simulated Industrial Tasks
After designing a first prototype of next generation industrial exoskeleton, the system should be evaluated in laboratory conditions. In order to evaluate the passive shoulder exoskeleton, designed to assist workers, a protocol is developed in which parts of industrial work is simulated. The results of this evaluation will serve as input for the next iterative design process/cycle of the prototype.
In this study 15 subjects will be recruited. During a 3.5h lab visit, each subject will perform three identical experimental trials; one trial without exoskeleton, one trial with a commercially available exoskeleton and one with the newly developed prototype. To avoid sequence bias, the order of the trials will be randomized (counterbalanced). The protocol consists of 6 tasks, always performed in the same sequence; lifting 5 kg 5 times from hip height to overhead height, completing a wiring task overhead (90 sec), 6 minutes walking, 6 min lifting from hip to overhead height (10 kg), 6 min lifting from ground to hip level (10 kg) and drilling for 30 sec with a force of 60N (±20 N). Before each task, 5 min of rest will be provided, and the subject will receive 10 min of rest in between different experimental trials. Electrocardiographic data, chest expansion and skin temperature will be monitored through a belt (Equivital, AD Instruments). An ergospirometric device (K5, Cosmed) will be used to gather gas exchange data, and (non-invasive) EMG electrodes will be applied to collect muscle activity data during the trials (Cometa). IMUs will be applied to the subjects' extremities to analyse the movement pattern (Technaid). Furthermore, questionnaires will be filled out to assess the subjective experience (Rating of Perceived Exertion, Sustained Usability Scale, Local Discomfort Scale).
- Conditions
- Exoskeleton Device
- Being tested
- Industrial passive shoulder exoskeleton
- Keywords
- Human-centered robotics, Prototype evaluation, Industry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Industrial passive shoulder exoskeletonDevice
Both exoskeleton types are passive shoulder exoskeletons. The goal is to compare the human response to the simulated industrial tasks between the different exoskeleton conditions.
| Study group | Role | What they receive |
|---|---|---|
| Prototype exoskeleon | Experimental | The experimental trial will be performed with the prototype exoskeleton Receives: Device: Industrial passive shoulder exoskeleton |
| Skel-Ex | Experimental | The experimental protocol will be performed with the commercially available Skel-Ex 360 (Skel-Ex, Rotterdam, The Netherlands) Receives: Device: Industrial passive shoulder exoskeleton |
| No exoskeleton | Experimental | The experimental protocol will be performed without exoskeleton. Receives: Device: Industrial passive shoulder exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: erector spinae, biceps femoris, rectus femoris, gastrocnemius, tibialis anterior, trapezius (all three parts), deltoideus (all three parts), pectoralis major, latissimus dorsi, brachioradialis, biceps brachii, triceps brachii on both the left and 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 activities, maximal voluntary isometric contractions (MVIC) 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 MVIC value. The outcomes will be the activities of the muscles (as a percentage of the MVIC) monitored during the tests.
Measured: Electromyographic data will be collected continuously during all simulated industrial tasks. This will take 3 hours in total.
Heart rate
An Equivital belt will be worn by all subject. heart rate can be computed from the ECG signal
Measured: Heart rate will be monitored continuously during all tasks. This will take 3 hours in total
Metabolic cost
A Cosmed K5 device will be used to measure oxygen consumption and carbon dioxide exhaust during every task lasting longer than three minutes. The outcome measures are the metabolic cost during walking, overhead lifting and lower lifting. The metabolic cost will be computed with the measured oxygen consumption and carbon dioxide exhaust.
Measured: Metabolic cost will be monitored continuously during all tasks. This will take 3 hours in total
session Rating of Perceived exertion
This questionnaire scores the perceived exertion during a task. Scores can range from 6 to 20, with 6 being not exhausted at all and 20 being extremely exhausted. The scale is only one question, so no sub-scales are available
Measured: the sRPE will be asked at the end of the task. The entire protocol will last for approximately 3 hours.
Secondary outcomes (1)
Heart rate variability
The distance between R peaks in the electrocardiogram
Measured: Will be computed for every task. The recording will be continuous throughout the whole protocol, lasting for approximately 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start30 Oct 2019
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exoskeleton DeviceStudies 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
- Randomized counterbalanced cross-over design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
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, Prof. dr., Principal investigator, VUB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105101
- Sponsor's protocol ID
- EXOTEST2019
- Status last verified
- Apr 2021
- First submitted
- 19 Sep 2019
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data can not be made public as this is part of a larger project
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Novel Passive Shoulder Exoskeleton on the Human Body During Simulated Industrial Tasks
- ClinicalTrials.gov ID
- NCT04105101
- Acronym / sponsor ID
- EXOTEST2019
- Conditions
- Exoskeleton Device
- Keywords
- Human-centered robotics, Prototype evaluation, Industry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 26 Sep 2019 (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.
After designing a first prototype of next generation industrial exoskeleton, the system should be evaluated in laboratory conditions. In order to evaluate the passive shoulder exoskeleton, designed to assist workers, a protocol is developed in which parts of industrial work is simulated. The results of this evaluation will serve as input for the next iterative design process/cycle of the prototype.
In this study 15 subjects will be recruited. During a 3.5h lab visit, each subject will perform three identical experimental trials; one trial without exoskeleton, one trial with a commercially available exoskeleton and one with the newly developed prototype. To avoid sequence bias, the order of the trials will be randomized (counterbalanced). The protocol consists of 6 tasks, always performed in the same sequence; lifting 5 kg 5 times from hip height to overhead height, completing a wiring task overhead (90 sec), 6 minutes walking, 6 min lifting from hip to overhead height (10 kg), 6 min lifting from ground to hip level (10 kg) and drilling for 30 sec with a force of 60N (±20 N). Before each task, 5 min of rest will be provided, and the subject will receive 10 min of rest in between different experimental trials. Electrocardiographic data, chest expansion and skin temperature will be monitored through a belt (Equivital, AD Instruments). An ergospirometric device (K5, Cosmed) will be used to gather gas exchange data, and (non-invasive) EMG electrodes will be applied to collect muscle activity data during the trials (Cometa). IMUs will be applied to the subjects' extremities to analyse the movement pattern (Technaid). Furthermore, questionnaires will be filled out to assess the subjective experience (Rating of Perceived Exertion, Sustained Usability Scale, Local Discomfort Scale).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized counterbalanced cross-over design
| Arm | Type | Receives |
|---|---|---|
| Prototype exoskeleon | Experimental | Device: Industrial passive shoulder exoskeletonThe experimental trial will be performed with the prototype exoskeleton |
| Skel-Ex | Experimental | Device: Industrial passive shoulder exoskeletonThe experimental protocol will be performed with the commercially available Skel-Ex 360 (Skel-Ex, Rotterdam, The Netherlands) |
| No exoskeleton | Experimental | Device: Industrial passive shoulder exoskeletonThe experimental protocol will be performed without exoskeleton. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy individuals (based on ParQ questionnaire)
Key exclusion criteria (3 listed)
- work related disorders
- shoulder injuries in the past
- back injuries in the past
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 |
|---|---|---|
| Industrial passive shoulder exoskeletonBoth exoskeleton types are passive shoulder exoskeletons. The goal is to compare the human response to the simulated industrial tasks between the different exoskeleton conditions. | Device | No exoskeleton, Prototype exoskeleon, Skel-Ex |
Primary outcome
Surface electromyography
Time frame: Electromyographic data will be collected continuously during all simulated industrial tasks. This will take 3 hours in total.
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: erector spinae, biceps femoris, rectus femoris, gastrocnemius, tibialis anterior, trapezius (all three parts), deltoideus (all three parts), pectoralis major, latissimus dorsi, brachioradialis, biceps brachii, triceps brachii on both the left and 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 activities, maximal voluntary isometric contractions (MVIC) 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 MVIC value. The outcomes will be the activities of the muscles (as a percentage of the MVIC) monitored during the tests.
Heart rate
Time frame: Heart rate will be monitored continuously during all tasks. This will take 3 hours in total
An Equivital belt will be worn by all subject. heart rate can be computed from the ECG signal
Metabolic cost
Time frame: Metabolic cost will be monitored continuously during all tasks. This will take 3 hours in total
A Cosmed K5 device will be used to measure oxygen consumption and carbon dioxide exhaust during every task lasting longer than three minutes. The outcome measures are the metabolic cost during walking, overhead lifting and lower lifting. The metabolic cost will be computed with the measured oxygen consumption and carbon dioxide exhaust.
session Rating of Perceived exertion
Time frame: the sRPE will be asked at the end of the task. The entire protocol will last for approximately 3 hours.
This questionnaire scores the perceived exertion during a task. Scores can range from 6 to 20, with 6 being not exhausted at all and 20 being extremely exhausted. The scale is only one question, so no sub-scales are available
1 secondary outcome
Heart rate variability
Time frame: Will be computed for every task. The recording will be continuous throughout the whole protocol, lasting for approximately 3 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No. The data can not be made public as this is part of a larger project
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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, Prof. dr. principal investigator
VUB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Industrial passive shoulder exoskeleton in people with Exoskeleton Device, 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 1 inclusion and 3 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 20 Apr 2021. 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?
Surface electromyography (time frame: Electromyographic data will be collected continuously during all simulated industrial tasks. This will take 3 hours in total.). The study lists 4 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 20 Apr 2021.