Ergonomic Effects of Using a Professional Passive Exoskeleton

NCT06193018 | Completed

• 1 other identifier: 2732
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Occupational Exposure

Keywords

Wearable devices; Electromyography; Ergonomics; Digital signal processing; Overhead work; Upper limbs supporting exoskeleton

Outcome Measures

Primary Outcomes (1)

• 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

  baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

workers at the company, on a voluntary basis

You may qualify if:

• workers of the textile sector

You may not qualify if:

• acute disabling pathologies or presence of internal complications contraindicating the carrying out of activities involving the lumbar- pelvic sector

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (4)

ICS Maugeri

Telese Terme, Bari, 82037, Italy

Location

ICS Maugeri

Montescano, Pavia, 27040, Italy

Location

ICS Maugeri

Bari, 70100, Italy

Location

ICS Maugeri

Pavia, 27100, Italy

Location

Study Officials

• Edda Capodaglio, PhD

  Istituti Clinici Scientifici Maugeri SpA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: May 10, 2023
• Primary Completion: November 11, 2024
• Study Completion: December 20, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-01

Locations

IT (4)