Effectiveness of an Occupational Passive Back-exoskeletons on the Biomechanical Load of Warehouse Workers. (EXO4MMH)

January 31, 2024 updated by: Lasse Schrøder Jakobsen, Aalborg University

Effectiveness of an Occupational Back-exoskeleton on the Biomechanical Load in Manual Materials Handling - A Randomized Controlled Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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, 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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Pascal Madeleine, Professor
  • Phone Number: +45 9940 8833
  • Email: pm@hst.aau.dk

Study Locations

  • Denmark
      • Gistrup, Denmark, 9260
        • Recruiting
        • Aalborg University
        • Contact:
        • Contact:
          • Pascal Madeleine, Professor
          • Phone Number: +4599408833
          • Email: pm@hst.aau.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (INT)
Group receiving intervention
Device: Use of an occupational passive back-exoskeleton
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.
No Intervention: Control (CON)
Group receiving no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomechanics
Time Frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
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.
Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived effort
Time Frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
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.
Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Comfort and Performance
Time Frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
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.
Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Liking
Time Frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
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.
Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Exertion
Time Frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
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.
Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Musculoskeletal discomfort
Time Frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
assessed using the Cornell Musculoskeletal Discomfort Questionnaire [15]. The questionnaire will be filled at baseline and every fourth week during the trial.
Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
Productivity
Time Frame: Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.
assessed using Dagrofa Logistics A/S normal measurement for productivity of the worker. Changes in productivity will be tracked on a weekly basis.
Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reporting of exoskeleton-use during the 24-week trial
Time Frame: Reported every week up to 24 weeks of the intervention
The self-reporting will be an estimation of weekly use (in hours) of the exoskeleton.
Reported every week up to 24 weeks of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University

Collaborators

Dagrofa Logistics A/S

Investigators

  • Study Director: Pascal Madeleine, Professor, Aalborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Estimated)

February 20, 2024

Study Completion (Estimated)

May 20, 2024

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAU-LBK1083

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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