Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06193018 |
| Other study ID # |
2732 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2023 |
| Est. completion date |
December 20, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Istituti Clinici Scientifici Maugeri SpA |
| Contact |
Edda Capodaglio |
| Phone |
+39 0382 593746 |
| Email |
edda.capodaglio[@]icsmaugeri.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
