An interventional study of Use of an occupational passive back-exoskeleton in Work-related Musculoskeletal Disorders, sponsored by Aalborg University. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Aalborg University · Not applicable, Interventional, and Prevention
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.
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, e.g., 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, e.g., 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.
657 studies on the registry are indexed under Musculoskeletal Diseases; 160 are open to participants now.
This study's enrollment of 20 is below the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
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I) full-time employed at the F\&G department at Dagrofa Logistics A/S. II) no major injuries affecting their daily work. III) no plans of retiring before the end of the study period.
Exclusion Criteria:
I) body compositions unable to fit the exoskeleton (bad fit). II) part-time workers. III) previous low-back injury
Group receiving intervention
Device: Use of an occupational passive back-exoskeleton
Group receiving no intervention
The experimental group will use an occupational passive back-exoskeleton (ShoulderX V3, Ottobock bionics) for a period of 24 weeks during working hours. The exoskeleton is designed to reduce the load of the lower back during manual materials handling. The first four weeks will serve as a familiarization period, where the workers will slowly progress in hours of exoskeleton-use, while they in the remaining twenty weeks will be free to use the exoskeleton as much as they like, with a minimum limit of 18 hours per week. The control group will carry on their normal work without any changes.
Biomechanics
Changes in the biomechanics of the back i) with / without wearing the passive back-exoskeleton during manual handling tasks, and ii) pre / post the 24-week trial when wearing the passive back-exoskeleton during manual handling tasks. Muscle activity will be collected using surface electromyography (sEMG) of the erectus spinae, descent trapezius and rectus abdominis muscles, while kinematics will be collected using inertial measurement unit (IMU) based motion capture. In relation to previous studies conducted in the PhD (study 1 and 2), the 10th and 90th percentile of sEMG amplitude and joint angles during the work tasks will be investigated.
Time frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Perceived effort
assessed using Borg Category-Ratio (CR) scale (0 = No effort, 10 = Maximal effort) to evaluate the work tasks conducted during the pre- and post-tests.
Time frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Comfort and Performance
assessed using a questionnaire including questions on fit and (thermal) comfort, balance, range-of-motion, safety, and perceived job performance. All questions are answered using a 10-point likert-scale (e.g., 0 = no discomfort and 10 = most discomfort) \[13\]. The questionnaire will be filled at baseline and every fourth week during the trial.
Time frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Liking
assessed using open-ended questions on liking: Q1: "What do you most like about the exoskeleton?", Q2: "What do you least like about the exoskeleton?", Q3: "If you could change anything about the exoskeleton, what would you change?" \[13\]. The questions will be answered at baseline and every fourth week during the trial.
Time frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Exertion
assessed using a questionnaire including questions on exertion. All question are answered using a 10-point likert-scale (e.g. 0 = strongly disagree and 10 = strongly agree) \[14\]. The questionnaire will be filled at baseline and every fourth week during the trial.
Time frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Musculoskeletal discomfort
assessed using the Cornell Musculoskeletal Discomfort Questionnaire \[15\]. The questionnaire will be filled at baseline and every fourth week during the trial.
Time frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Productivity
assessed using Dagrofa Logistics A/S normal measurement for productivity of the worker. Changes in productivity will be tracked on a weekly basis.
Time frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Self-reporting of exoskeleton-use during the 24-week trial
The self-reporting will be an estimation of weekly use (in hours) of the exoskeleton.
Time frame: Reported every week up to 24 weeks of the intervention
Plan to share: No
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Aalborg University