Viewing Study NCT05890300



Ignite Creation Date: 2024-05-06 @ 7:07 PM
Last Modification Date: 2024-10-26 @ 3:00 PM
Study NCT ID: NCT05890300
Status: RECRUITING
Last Update Posted: 2024-02-01
First Post: 2023-04-27

Brief Title: Effectiveness of an Occupational Passive Back-exoskeletons on the Biomechanical Load of Warehouse Workers
Sponsor: Aalborg University
Organization: Aalborg University

Study Overview

Official Title: Effectiveness of an Occupational Back-exoskeleton on the Biomechanical Load in Manual Materials Handling - A Randomized Controlled Trial
Status: RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EXO4MMH
Brief Summary: Development of work-related musculoskeletal disorders WMSDs is a common issue within logistics manual materials handling which is associated with the high physical demands of the workers Especially back injuries are highly represented among manual workers in logistics Occupational exoskeletons are seen as a solution to this issue as it has shown to reduce the muscle activity during several manual handling tasks within manufacturing construction work mechanics and logistics However there is a major gap in scientific literature on studies investigating in-field effects of exoskeleton-use on longer terms which means that we in general have very little knowledge on the pros and cons of implementing exoskeletons in the product-line of logistics Consequently our current understanding of how a back-supporting occupational exoskeleton can benefit the manual workers of a logistics company is limited

The purpose of this study is to investigate i the long-term effects of a passive back-exoskeleton during manual materials handling on the biomechanics of the user ii the changes in comfort well-being and productivity pre and post to implementation of passive back-exoskeleton It is hypothesized that exoskeleton-use will maintain a reduction in muscle activity of the manual workers and increase their overall well-being without affecting their productivity
Detailed Description: Manual materials handling MMH is common in warehouse work and often includes tasks causing high physical requirements on the manual workers involved An outcome of these strenuous tasks due to a challenging physical environment is often overexertion which can cause attrition and in some cases lead to sickness absences and work-related musculoskeletal disorders WMSDs Musculoskeletal disorders are the main cause to disabling injuries in United States businesses leading to an annual direct cost of 14 billion These disorders are often accompanied by low-back pain causing the most years lived with disability worldwide Additionally in Denmark 37 of all work-related disorders are related to musculoskeletal load making it the biggest contributor to sick leave In 2019 the annual cost of work-related injuries was estimated to USD 600 million

Wearable personal assistive systems like exoskeletons were initially designed for rehabilitation purposes eg walking aid and later for military applications Recently exoskeletons have been introduced for occupational use According to the European Agency for Safety and Health at Work EUOSHA body-worn exoskeletons are right now being implemented as assistive devices to manual labour at workplaces all over Europe Occupational exoskeletons were first seen in Danish industrial companies in 2019 where it was adopted by automotive industry Exoskeletons are an attractive solution to the issues related to the physical loads carried out by workers during MMH Still there is a lack of studies examining the benefits risks and barriers to the implementation of exoskeletons in industry Most of the research on occupational exoskeletons have been conducted in laboratory setups or by simulating work-tasks in ideal conditions while in-situ exoskeletons use to reflect real-life aspects have almost never been investigated Despite the lack of research exoskeletons have been proven beneficial since lower muscle load indicated by surface electromyography and lower discomfort have been reported Yet several limitations because of wearing the exoskeletons have been underlined modifications of the kinematics in form of lower range of motion and increased heart rate Additionally it is found that unloading of a specific joint can induce increased loading of other body areas leading to higher fatigue and exertion besides mixed effects on heart rate and usability

Current research indicates that occupational exoskeletons decrease the biomechanical load during MMH This can lead to a positive effect towards the development of muscle fatigue of target areas of the body and work-related musculoskeletal disorders Yet there are many unexplored aspects of the implementations of exoskeletons to occupational use regarding neuromuscular coordination changes in kinematics discomfort postural strain due to the weight of the exoskeleton and difficulty for workers to perform smooth movement

This underlines the need to clarify the pros and cons of occupational exoskeleton use To improve the implementation of the exoskeletons in the industry it is important to determinate which working tasks is suitable for which exoskeletons Furthermore it is relevant to identify which environmental conditions that may contraindicate the use of occupational exoskeletons eg working in a confined space or the need of high physical precision Concluding to explore the important factors driving the adoption of occupational exoskeletons for industrial use in particular identification of key facilitators and barriers a large-scale of field studies is needed before being able to identify the benefits and limitations of the implementation of exoskeleton use Such studies should include a wide range of workers and working tasks and include health-relevant outcomes like musculoskeletal disorders

Thus the purpose of this study is to investigate the long-term effects of exoskeleton-use during MMH In this study the warehouse workers will participate in a 24-week randomized controlled trial RCT investigating the prospective effects of a passive back-exoskeleton-use The exoskeleton used in the present study is based on initial findings of a 5-week trial which showed that this exoskeleton induced higher acceptance among the workers attendance and lower discomfort During the intervention parameters of muscular and kinematic changes perceived effort comfort and performance liking exertion musculoskeletal discomfort and productivity will be monitored

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None