Occupational ExposureNCT06193018
Ergonomic Effects of Using a Professional Passive Exoskeleton
An observational study of Occupational Exposure, run by Istituti Clinici Scientifici Maugeri SpA at 4 sites in Italy.
Trial summary
Work-related musculoskeletal disorders (WRMSD), multifactorial diseases that affect the working population and which can be caused and/or aggravated by work and occupational exposures, continue to Prevention interventions for these pathologies have recently made use of technological advancement, which has made… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Occupational Exposure
- How many people
- 8 participants
- Where
- 4 sitesItaly
- Study dates
- 10 May 2023to 20 Dec 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: workers at the company, on a voluntary basis
Who may be able to join
- workers of the textile sector
Who cannot join
- acute disabling pathologies or presence of internal complications contraindicating the carrying out of activities involving the lumbar- pelvic sector
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
ICS Maugeri
Bari, 70100
ICS Maugeri
Montescano, Pavia, 27040
ICS Maugeri
Pavia, 27100
ICS Maugeri
Telese Terme, Bari, 82037
About this study
Official title: Ergonomic Effects of Using a Passive Upper Extremity Exoskeleton in Workers During Industrial Production Activities
Work-related musculoskeletal disorders (WRMSD), multifactorial diseases that affect the working population and which can be caused and/or aggravated by work and occupational exposures, continue to Prevention interventions for these pathologies have recently made use of technological advancement, which has made external devices available for the assistance of human activities, i.e. occupational exoskeletons (EXO). Despite the suggestive potential inherent in these devices, their actual adoption in the working and industrial world is still uncertain due to the absence of evidence on their effectiveness, safety of use and appropriateness.
The use of EXO increases the user's ability to carry out manual tasks in different work contexts, lightening the perception of physical effort and promoting higher levels of safety, as well as promoting better performance. These advantages derive from the effective reduction in muscle activity that the use of EXO allows. A certain variability in the effects was referred to factors such as the type of work task, the type of exoskeleton adopted, the duration of use of the exoskeleton, as well as to individual differences and different behaviours at work.
Read more
The field studies, carried out so far in the automotive, manufacturing, logistics and agriculture sectors, are fundamental to understanding the actual effectiveness, practicality, safety and acceptance of EXO by the user.
This project contributes to the expansion of knowledge relating to the prevention of WRMSD through EXO, applying wearable sensors in a real working situation such as the textile sector, in which the female gender constitutes the majority of the workforce.
Read the detailed description
The study involved the voluntary recruitment of eight workers in the sector, aged between 18 and 65, excluding those who had acute disabling pathologies or the presence of internal complications contraindicating the carrying out of activities involving the lumbar- pelvic.
Experimental part: performance of the identified work tasks (three different types, each assessed for biomechanical risk) by each worker in condition of use of EXO (EXO) and in condition of non-use (FREE). While carrying out the tasks (each with fixed frequency and duration parameters) in both conditions, workers were equipped with sensors applied on the dominant side, on the appropriate body points for the detection of electromyographic and kinematic data.
Processing of kinematic and electromyographic signals: the signals obtained from the inertial measurement unit (IMU) sensors were processed in order to quantify both the levels of muscular activity of each district analyzed and the postures adopted during the performance of the tasks.
General objective of the study was the evaluation of the effects of the use of EXO in a real working context, during repetitive activity of the upper limbs, in relation to muscular and postural commitment.
Specific objectives were:
- determine the level of muscular activity of the shoulder sectors (anterior and medial deltoid) and lumbar spine, in EXO and FREE conditions;
- determine the posture (ROM and temporal distribution of angular positions) of the sectors: shoulder, elbow, trunk in EXO and FREE conditions;
- determine the worker's perceptions regarding comfort, safety, fatigue, adaptability and usability of the device, in EXO conditions.
- Conditions
- Occupational Exposure
- Keywords
- Wearable devices, Electromyography, Ergonomics, Digital signal processing, Overhead work, Upper limbs supporting exoskeleton
What is being measured
The primary outcome is the main question the study is designed to answer.
muscular activity of the shoulder sectors
Electromyography root-mean-square (RMS) of the shoulder sectors (anterior and medial deltoid) and lumbar spine was determined in the EXO and in the FREE condition
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 May 2023
- Primary completion11 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edda Capodaglio, PhD, Principal investigator, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193018
- Sponsor's protocol ID
- 2732
- Status last verified
- Jan 2025
- First submitted
- 21 Dec 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergonomic Effects of Using a Passive Upper Extremity Exoskeleton in Workers During Industrial Production Activities
- ClinicalTrials.gov ID
- NCT06193018
- Acronym / sponsor ID
- 2732
- Conditions
- Occupational Exposure
- Keywords
- Wearable devices, Electromyography, Ergonomics, Digital signal processing, Overhead work, Upper limbs supporting exoskeleton
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 5 Jan 2024 (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.
Work-related musculoskeletal disorders (WRMSD), multifactorial diseases that affect the working population and which can be caused and/or aggravated by work and occupational exposures, continue to Prevention interventions for these pathologies have recently made use of technological advancement, which has made external devices available for the assistance of human activities, i.e. occupational exoskeletons (EXO). Despite the suggestive potential inherent in these devices, their actual adoption in the working and industrial world is still uncertain due to the absence of evidence on their effectiveness, safety of use and appropriateness.
The use of EXO increases the user's ability to carry out manual tasks in different work contexts, lightening the perception of physical effort and promoting higher levels of safety, as well as promoting better performance. These advantages derive from the effective reduction in muscle activity that the use of EXO allows. A certain variability in the effects was referred to factors such as the type of work task, the type of exoskeleton adopted, the duration of use of the exoskeleton, as well as to individual differences and different behaviours at work.
The field studies, carried out so far in the automotive, manufacturing, logistics and agriculture sectors, are fundamental to understanding the actual effectiveness, practicality, safety and acceptance of EXO by the user.
This project contributes to the expansion of knowledge relating to the prevention of WRMSD through EXO, applying wearable sensors in a real working situation such as the textile sector, in which the female gender constitutes the majority of the workforce.
Detailed description
The study involved the voluntary recruitment of eight workers in the sector, aged between 18 and 65, excluding those who had acute disabling pathologies or the presence of internal complications contraindicating the carrying out of activities involving the lumbar- pelvic.
Experimental part: performance of the identified work tasks (three different types, each assessed for biomechanical risk) by each worker in condition of use of EXO (EXO) and in condition of non-use (FREE). While carrying out the tasks (each with fixed frequency and duration parameters) in both conditions, workers were equipped with sensors applied on the dominant side, on the appropriate body points for the detection of electromyographic and kinematic data.
Processing of kinematic and electromyographic signals: the signals obtained from the inertial measurement unit (IMU) sensors were processed in order to quantify both the levels of muscular activity of each district analyzed and the postures adopted during the performance of the tasks.
General objective of the study was the evaluation of the effects of the use of EXO in a real working context, during repetitive activity of the upper limbs, in relation to muscular and postural commitment.
Specific objectives were:
- determine the level of muscular activity of the shoulder sectors (anterior and medial deltoid) and lumbar spine, in EXO and FREE conditions;
- determine the posture (ROM and temporal distribution of angular positions) of the sectors: shoulder, elbow, trunk in EXO and FREE conditions;
- determine the worker's perceptions regarding comfort, safety, fatigue, adaptability and usability of the device, in EXO conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- workers at the company, on a voluntary basis
Key inclusion criteria (1 listed)
- workers of the textile sector
Key exclusion criteria (1 listed)
- acute disabling pathologies or presence of internal complications contraindicating the carrying out of activities involving the lumbar- pelvic sector
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
muscular activity of the shoulder sectors
Time frame: baseline
Electromyography root-mean-square (RMS) of the shoulder sectors (anterior and medial deltoid) and lumbar spine was determined in the EXO and in the FREE condition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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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.
Edda Capodaglio, PhD principal investigator
Istituti Clinici Scientifici Maugeri SpA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Exposure, run by Istituti Clinici Scientifici Maugeri SpA at 4 sites in Italy.
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 1 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: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
muscular activity of the shoulder sectors (time frame: baseline). 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 19 Feb 2025.