Work-Related Musculoskeletal DisordersRELAXNCT07561112
The Impact of Back-supporting Exoskeletons for Manual Order Picking in Danish Warehouses - The RELAX Project
A study testing Use of an occupational passive back-exoskeleton in people with Work-Related Musculoskeletal Disorders, run by Aalborg University at 1 site in Denmark.
Trial summary
This study investigates the long-term effects of implementing a passive back-support exoskeleton during manual order-picking work in a real-world warehouse environment. Work-related musculoskeletal disorders, particularly low back pain, are common among logistics workers due to frequent lifting, repetitive movements… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Work-Related Musculoskeletal Disorders
- What is being tested?
- Use of an occupational passive back-exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2026to 31 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-65 years at enrolment
- full-time employment in the current work department
- no major pain or injuries affecting daily work tasks
Who cannot join
- anthropometric characteristics preventing adequate fit of the exoskeleton
- part-time employment
- pregnancy or anticipated prolonged absence from work during the study period (standard vacation not included)
- If a participating worker from either the intervention or control group transfers to another department within the company during the intervention period for reasons unrelated to the intervention, the participant will be excluded from the study. Such cases will be classified as dropouts and the corresponding data will be reported as lost to follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Aalborg University
Aalborg, 9000
Pascal Madeleine, Professor, 0045 99408833, pm@hst.aau.dk
Lasse S. Jakobsen, PhD, 0045 72332998, lsja@hst.aau.dk
About this study
Official title: The Impact of Back-supporting Exoskeletons for Manual Order Picking in Danish Warehouses - The RELAX Project - Protocol for an 18-month In-field Controlled Intervention Study
This study investigates the long-term effects of implementing a passive back-support exoskeleton during manual order-picking work in a real-world warehouse environment. Work-related musculoskeletal disorders, particularly low back pain, are common among logistics workers due to frequent lifting, repetitive movements, and awkward postures. Although laboratory studies suggest that occupational exoskeletons can reduce biomechanical load, evidence from long-term, real-world workplace implementations remains limited.
The RELAX project is an 18-month controlled in-field intervention study conducted in two departments of a Danish warehouse. Approximately 90 full-time warehouse workers will participate. Workers in the intervention department will use a passive back-support exoskeleton during manual order-picking tasks, while workers in the control department will continue their work as usual.
Read more
The primary outcomes include sickness absence, employee turnover, perceived work intensity, and musculoskeletal discomfort. Secondary outcomes include productivity, user acceptance of the exoskeleton, and cost-effectiveness of the intervention. Outcomes will be assessed through company records, repeated questionnaires, and focus-group interviews over the 18-month period.
By combining longitudinal quantitative outcomes with qualitative process evaluation, the study aims to determine whether long-term use of a passive back-support exoskeleton can improve worker well-being and reduce work-related musculoskeletal burden without negatively affecting productivity. The results may inform workplace policies and future implementation of occupational exoskeletons in physically demanding industries.
Read the detailed description
Work-related musculoskeletal disorders (WMSDs) are among the most common occupational health problems worldwide. Workers employed in physically demanding sectors such as logistics frequently perform repetitive lifting, forward bending, and manual material handling tasks. These exposures place considerable mechanical strain on the musculoskeletal system and are associated with an increased risk of lower back pain, fatigue, and long-term sickness absence. Low back pain is particularly prevalent among manual workers and represents a major cause of reduced work ability, decreased quality of life, and economic costs for both employers and society.
In recent years, occupational exoskeletons have been introduced as a potential ergonomic intervention to reduce physical workload during demanding manual tasks. Occupational exoskeletons are wearable assistive devices designed to support the musculoskeletal system by redistributing loads and assisting body movements. Passive back-support exoskeletons in particular aim to reduce mechanical loading of the lower back during tasks involving forward bending and lifting. Laboratory-based studies have shown that these devices can reduce muscle activity in the trunk and may lower perceived effort during lifting tasks. However, most existing studies have been conducted in short-term laboratory environments or controlled simulations, and there is still limited evidence regarding the long-term effectiveness and feasibility of exoskeleton use in real workplace settings.
The complexity of real-world effects of occupational exoskeletons is an important aspect, as workplace environments and user acceptance are often dynamic. In addition to potential biomechanical benefits, factors such as usability, worker acceptance, productivity requirements, organizational practices, and long-term adherence can strongly influence the success of implementing exoskeleton use. Previous research suggests that although exoskeletons may reduce muscle load, they may also introduce challenges such as discomfort, perceived restrictions in movement, or changes in work behavior. Consequently, long-term field studies are needed to evaluate whether exoskeleton use leads to meaningful improvements in worker health and well-being without negatively affecting productivity or workplace safety.
The RELAX project (Reduction of the Lifting Load Among logistics workers through passive back eXoskeleton) was designed to address these knowledge gaps. The aim of the study is to investigate the long-term effects of implementing a passive back-support exoskeleton during manual order-picking tasks in a real-world logistics environment. The study focuses on outcomes related to worker health, well-being, organizational performance, and economic impact. Specifically, the project examines whether prolonged use of a back-support exoskeleton reduces sickness absence, employee turnover, perceived work intensity, and musculoskeletal discomfort while maintaining or improving productivity.
The study is conducted as an 18-month controlled in-field intervention at a logistics warehouse in Denmark. Approximately 90 full-time warehouse workers from two departments of the same company are expected to participate. One department will serve as the intervention group, where workers will use a passive back-support exoskeleton during physically demanding order-picking tasks. The other department will serve as the control group and will continue performing the same work tasks without exoskeleton assistance. The two departments operate under similar working conditions, including comparable workflows, temperature, and equipment, which allows for meaningful comparison between groups.
The device used in the present study is a passive back-support exoskeleton designed to reduce the mechanical loading of the lumbar spine during forward bending and lifting movements. The device functions without motors or batteries and instead uses a mechanical structure to transfer part of the load from the upper body to the pelvis and lower extremities. When a worker bends forward, the device provides supportive torque that assists the trunk and reduces the effort required from the back muscles. When the worker returns to an upright posture or walks, the assistance disengages, allowing normal movement. The device is lightweight (<3.0 kg), worn externally over work clothing, and adjustable to accommodate different body sizes.
To facilitate successful implementation of the intervention, a structured rollout process will be used. Workers in the intervention department will first participate in introduction sessions explaining the purpose of the project, the function of the exoskeleton, and safety considerations. Exoskeleton use will then be gradually introduced through a stepwise familiarization process that allows workers to adapt to the device over time. During this period, trained personnel and company representatives will provide technical and ergonomic support to ensure appropriate fitting and safe usage. Workers will be encouraged to use the device during physically demanding tasks but will remain free to remove or disengage it when necessary, reflecting normal workplace practice.
Data will be collected repeatedly throughout the 18-month study period. Both quantitative and qualitative methods will be used to evaluate the effects of the intervention. This mixed-methods approach allows the study to capture not only measurable outcomes but also the experiences and perspectives of workers and workplace stakeholders.
The primary outcomes of the study relate to worker health and well-being. These include sickness absence, employee turnover, perceived work intensity during work shifts, and musculoskeletal discomfort. Sickness absence and employee turnover will be obtained from company administrative records. Perceived work intensity and musculoskeletal discomfort will be assessed through standardized questionnaires completed by participants at regular intervals throughout the study. These measures will help determine whether the exoskeleton intervention reduces physical strain and improves workers' overall experience of their daily work tasks.
Secondary outcomes focus on organizational and implementation-related aspects of exoskeleton use. These include productivity, worker acceptance of the device, and economic evaluation of the intervention. Productivity will be assessed using company performance indicators, such as the number of packages handled per hour. Worker acceptance will be evaluated through questionnaires and focus-group interviews examining perceptions of comfort, safety, usability, and perceived impact on work performance. Qualitative interviews with workers and relevant stakeholders will also explore experiences with implementation, barriers and facilitators to adoption, and how the exoskeleton fits into daily work routines.
An additional objective of the study is to evaluate the economic implications of implementing occupational exoskeletons in a logistics workplace. The costs associated with acquiring and implementing the devices, including training and operational resources, will be compared with potential economic benefits such as reduced sickness absence, lower employee turnover, and maintained or improved productivity. These analyses will provide estimates of cost-effectiveness and return on investment from both company and societal perspectives.
In addition to quantitative outcome analyses, qualitative data from focus-group interviews will be analyzed using thematic analysis to identify key themes related to user experiences, implementation processes, and contextual factors affecting exoskeleton adoption. Integrating qualitative and quantitative findings will provide a more comprehensive understanding of how occupational exoskeletons function in real-world settings and how they may influence both workers and organizations.
The RELAX project addresses an important gap in occupational health research by evaluating the long-term effects of exoskeleton use in an authentic workplace environment. Many previous studies have focused primarily on short-term biomechanical outcomes measured in controlled laboratory settings. By contrast, this study evaluates the broader impacts of exoskeleton implementation, including worker well-being, organizational outcomes, and economic considerations.
The findings of this study may contribute valuable evidence for employers, occupational health professionals, technology developers, and policymakers interested in improving working conditions in physically demanding industries. If passive back-support exoskeletons prove to reduce physical strain and improve worker well-being without negatively affecting productivity, they may represent a promising ergonomic intervention for preventing work-related musculoskeletal disorders in the logistics sector and other industries involving manual material handling.
Conversely, if the study identifies limitations, unintended effects, or barriers to successful implementation, these findings will also be important for guiding future research, device development, and workplace policy decisions. Overall, the RELAX project seeks to generate robust real-world evidence on the effectiveness, feasibility, and sustainability of occupational exoskeletons as a workplace intervention.
- Conditions
- Work-Related Musculoskeletal Disorders
- Being tested
- Use of an occupational passive back-exoskeleton
- Keywords
- Occupational Exoskeletons, Musculoskeletal Disorders, Manual Materials Handling, Ergonomics, Assistive Technology, Warehouse
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of an occupational passive back-exoskeletonDevice
Use of the IX Back AIR (SuitX by Ottobock) for 18 months during daily order picking tasks
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton group | Experimental | Group receiving intervention Receives: Device: Use of an occupational passive back-exoskeleton |
| Control Group | No intervention | Group receiving no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Work Intensity
Assessed using two 10-point Likert-scale questions on 1) how much they exert themselves during a shift and 2) how exhausted they feel at the end of a shift.
Measured: Reported at baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18.
Musculoskeletal Discomfort
Assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), completed monthly by workers as part of the questionnaire battery.
The questionnaire includes three questions on 1) how often they experienced discomfort during the last workweek (1-5, 5 being worst), 2) how uncomfortable it was (1-3, 3 being worst), and 3) if the discomfort interfered with their ability to work (1-3, 3 being worst). All questions will be answered for separate body regions. Analyses will primarily focus on reports of back discomfort.
Measured: Reported at baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18.
Secondary outcomes (3)
Sickness Absence
Measured as the number of days of sick leave per month as reported by the company. To assess whether sick leave was related to musculoskeletal issues, the questionnaire will include the question: "Have you had any sick leave related to musculoskeletal discomfort within the last month?"
Measured: Reported at baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18.
Employee Turnover
Measured as the number of monthly resignations in the respective department as reported by the company.
Measured: Time-to-event. Reported as the timepoint (in months) from baseline, when the resignation occurs.
Productivity
Productivity is a key performance indicator monitored by the company reported in packages per hour for each individual worker. In this study productivity will be reported as a weekly average.
Measured: Weekly during the 18-month intervention (Baseline to month 18).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Work-Related Musculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a controlled parallel-group workplace intervention study conducted over 18 months. Two comparable warehouse departments will be followed simultaneously: one department will implement a passive back-support exoskeleton during regular work tasks, while the other will continue usual practice without exoskeleton use. Allocation occurs at department level and is not randomized. All eligible full-time employees in both departments will be invited to participate and will be observed throughout the study period. Outcomes will be assessed repeatedly during follow-up using questionnaires and company records, allowing comparison of changes over time between the intervention and control groups under real-world working conditions.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre for the Working Environment, Denmark, Aarhus University Hospital, Royal College of Surgeons, Ireland, Ecole Normale Supérieure de Rennes
- Responsible party
- Principal investigator, Lasse Schrøder Jakobsen, Aalborg University
- Investigators
- Pascal Madeleine, Professor, Study director, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561112
- Sponsor's protocol ID
- AAU-LBK1268
- Acronym
- RELAX
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
1) J De Kok. Work-related musculoskeletal disorders: prevalence, costs and demographics in the EU European Risk Observatory Report. European Agency for Safety and Health at Work (2019) EU OSHA.
Skals S, Blafoss R, Andersen MS, de Zee M, Andersen LL. Manual material handling in the supermarket sector. Part 1: Joint angles and muscle activity of trapezius descendens and erector spinae longissimus. Appl Ergon. 2021 Apr;92:103340. doi: 10.1016/j.apergo.2020.103340. Epub 2020 Dec 16.
PubMed 33340719Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.
PubMed 16595438Popova MS, Nikolova SP, Filkova SI. Demographic and Occupational Determinants of Work-Related Musculoskeletal Disorders: A Cross-Sectional Study. J Funct Morphol Kinesiol. 2025 Apr 20;10(2):137. doi: 10.3390/jfmk10020137.
PubMed 40566433Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
PubMed 222314246) S Toxiri, MB Näf, M Lazzaroni, J Fernández, M Sposito, T Poliero, et al. Back-Support Exoskeletons for Occupational Use: An Overview of Technological Advances and Trends, IISE Transactions on Occupational Ergonomics and Human Factors. 7 (2019) 237.
7) H Kazerooni, W Tung, M Pillai. Evaluation of Trunk-Supporting Exoskeleton, Proceedings of the Human Factors and Ergonomics Society Annual Meeting. 63 (2019) 1080.
Crea S, Beckerle P, De Looze M, De Pauw K, Grazi L, Kermavnar T, Masood J, O'Sullivan LW, Pacifico I, Rodriguez-Guerrero C, Vitiello N, Ristic-Durrant D, Veneman J. Occupational exoskeletons: A roadmap toward large-scale adoption. Methodology and challenges of bringing exoskeletons to workplaces. Wearable Technol. 2021 Sep 17;2:e11. doi: 10.1017/wtc.2021.11. eCollection 2021.
PubMed 38486625Howard J, Murashov VV, Lowe BD, Lu ML. Industrial exoskeletons: Need for intervention effectiveness research. Am J Ind Med. 2020 Mar;63(3):201-208. doi: 10.1002/ajim.23080. Epub 2019 Dec 11.
PubMed 31828844Kranenborg SE, Greve C, Reneman MF, Roossien CC. Side-effects and adverse events of a shoulder- and back-support exoskeleton in workers: A systematic review. Appl Ergon. 2023 Sep;111:104042. doi: 10.1016/j.apergo.2023.104042. Epub 2023 May 3.
PubMed 3714632011) J Theurel, K Desbrosses. Occupational exoskeletons: overview of their benefits and limitations in preventing work-related musculoskeletal disorders. IISE Transactions on Occupational Ergonomics and Human Factors. 7 (2019) 264-280.
12) MA Nussbaum, BD Lowe, M De Looze, C Harris-Adamson, M Smets. An Introduction to the Special Issue on Occupational Exoskeletons, IISE Transactions on Occupational Ergonomics and Human Factors. 7 (2020) 153.
Bar M, Steinhilber B, Rieger MA, Luger T. The influence of using exoskeletons during occupational tasks on acute physical stress and strain compared to no exoskeleton - A systematic review and meta-analysis. Appl Ergon. 2021 Jul;94:103385. doi: 10.1016/j.apergo.2021.103385. Epub 2021 Mar 3.
PubMed 33676059Madinei S, Kim S, Park JH, Srinivasan D, Nussbaum MA. A novel approach to quantify the assistive torque profiles generated by passive back-support exoskeletons. J Biomech. 2022 Dec;145:111363. doi: 10.1016/j.jbiomech.2022.111363. Epub 2022 Oct 31.
PubMed 36332510Kim S, Nussbaum MA, Smets M, Ranganathan S. Effects of an arm-support exoskeleton on perceived work intensity and musculoskeletal discomfort: An 18-month field study in automotive assembly. Am J Ind Med. 2021 Nov;64(11):905-914. doi: 10.1002/ajim.23282. Epub 2021 Aug 6.
PubMed 34363229
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Back-supporting Exoskeletons for Manual Order Picking in Danish Warehouses - The RELAX Project - Protocol for an 18-month In-field Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT07561112
- Acronym / sponsor ID
- RELAX / AAU-LBK1268
- Conditions
- Work-Related Musculoskeletal Disorders
- Keywords
- Occupational Exoskeletons, Musculoskeletal Disorders, Manual Materials Handling, Ergonomics, Assistive Technology, Warehouse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- National Research Centre for the Working Environment, Denmark, Aarhus University Hospital, Royal College of Surgeons, Ireland, Ecole Normale Supérieure de Rennes
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the long-term effects of implementing a passive back-support exoskeleton during manual order-picking work in a real-world warehouse environment. Work-related musculoskeletal disorders, particularly low back pain, are common among logistics workers due to frequent lifting, repetitive movements, and awkward postures. Although laboratory studies suggest that occupational exoskeletons can reduce biomechanical load, evidence from long-term, real-world workplace implementations remains limited.
The RELAX project is an 18-month controlled in-field intervention study conducted in two departments of a Danish warehouse. Approximately 90 full-time warehouse workers will participate. Workers in the intervention department will use a passive back-support exoskeleton during manual order-picking tasks, while workers in the control department will continue their work as usual.
The primary outcomes include sickness absence, employee turnover, perceived work intensity, and musculoskeletal discomfort. Secondary outcomes include productivity, user acceptance of the exoskeleton, and cost-effectiveness of the intervention. Outcomes will be assessed through company records, repeated questionnaires, and focus-group interviews over the 18-month period.
By combining longitudinal quantitative outcomes with qualitative process evaluation, the study aims to determine whether long-term use of a passive back-support exoskeleton can improve worker well-being and reduce work-related musculoskeletal burden without negatively affecting productivity. The results may inform workplace policies and future implementation of occupational exoskeletons in physically demanding industries.
Detailed description
Work-related musculoskeletal disorders (WMSDs) are among the most common occupational health problems worldwide. Workers employed in physically demanding sectors such as logistics frequently perform repetitive lifting, forward bending, and manual material handling tasks. These exposures place considerable mechanical strain on the musculoskeletal system and are associated with an increased risk of lower back pain, fatigue, and long-term sickness absence. Low back pain is particularly prevalent among manual workers and represents a major cause of reduced work ability, decreased quality of life, and economic costs for both employers and society.
In recent years, occupational exoskeletons have been introduced as a potential ergonomic intervention to reduce physical workload during demanding manual tasks. Occupational exoskeletons are wearable assistive devices designed to support the musculoskeletal system by redistributing loads and assisting body movements. Passive back-support exoskeletons in particular aim to reduce mechanical loading of the lower back during tasks involving forward bending and lifting. Laboratory-based studies have shown that these devices can reduce muscle activity in the trunk and may lower perceived effort during lifting tasks. However, most existing studies have been conducted in short-term laboratory environments or controlled simulations, and there is still limited evidence regarding the long-term effectiveness and feasibility of exoskeleton use in real workplace settings.
The complexity of real-world effects of occupational exoskeletons is an important aspect, as workplace environments and user acceptance are often dynamic. In addition to potential biomechanical benefits, factors such as usability, worker acceptance, productivity requirements, organizational practices, and long-term adherence can strongly influence the success of implementing exoskeleton use. Previous research suggests that although exoskeletons may reduce muscle load, they may also introduce challenges such as discomfort, perceived restrictions in movement, or changes in work behavior. Consequently, long-term field studies are needed to evaluate whether exoskeleton use leads to meaningful improvements in worker health and well-being without negatively affecting productivity or workplace safety.
The RELAX project (Reduction of the Lifting Load Among logistics workers through passive back eXoskeleton) was designed to address these knowledge gaps. The aim of the study is to investigate the long-term effects of implementing a passive back-support exoskeleton during manual order-picking tasks in a real-world logistics environment. The study focuses on outcomes related to worker health, well-being, organizational performance, and economic impact. Specifically, the project examines whether prolonged use of a back-support exoskeleton reduces sickness absence, employee turnover, perceived work intensity, and musculoskeletal discomfort while maintaining or improving productivity.
The study is conducted as an 18-month controlled in-field intervention at a logistics warehouse in Denmark. Approximately 90 full-time warehouse workers from two departments of the same company are expected to participate. One department will serve as the intervention group, where workers will use a passive back-support exoskeleton during physically demanding order-picking tasks. The other department will serve as the control group and will continue performing the same work tasks without exoskeleton assistance. The two departments operate under similar working conditions, including comparable workflows, temperature, and equipment, which allows for meaningful comparison between groups.
The device used in the present study is a passive back-support exoskeleton designed to reduce the mechanical loading of the lumbar spine during forward bending and lifting movements. The device functions without motors or batteries and instead uses a mechanical structure to transfer part of the load from the upper body to the pelvis and lower extremities. When a worker bends forward, the device provides supportive torque that assists the trunk and reduces the effort required from the back muscles. When the worker returns to an upright posture or walks, the assistance disengages, allowing normal movement. The device is lightweight (<3.0 kg), worn externally over work clothing, and adjustable to accommodate different body sizes.
To facilitate successful implementation of the intervention, a structured rollout process will be used. Workers in the intervention department will first participate in introduction sessions explaining the purpose of the project, the function of the exoskeleton, and safety considerations. Exoskeleton use will then be gradually introduced through a stepwise familiarization process that allows workers to adapt to the device over time. During this period, trained personnel and company representatives will provide technical and ergonomic support to ensure appropriate fitting and safe usage. Workers will be encouraged to use the device during physically demanding tasks but will remain free to remove or disengage it when necessary, reflecting normal workplace practice.
Data will be collected repeatedly throughout the 18-month study period. Both quantitative and qualitative methods will be used to evaluate the effects of the intervention. This mixed-methods approach allows the study to capture not only measurable outcomes but also the experiences and perspectives of workers and workplace stakeholders.
The primary outcomes of the study relate to worker health and well-being. These include sickness absence, employee turnover, perceived work intensity during work shifts, and musculoskeletal discomfort. Sickness absence and employee turnover will be obtained from company administrative records. Perceived work intensity and musculoskeletal discomfort will be assessed through standardized questionnaires completed by participants at regular intervals throughout the study. These measures will help determine whether the exoskeleton intervention reduces physical strain and improves workers' overall experience of their daily work tasks.
Secondary outcomes focus on organizational and implementation-related aspects of exoskeleton use. These include productivity, worker acceptance of the device, and economic evaluation of the intervention. Productivity will be assessed using company performance indicators, such as the number of packages handled per hour. Worker acceptance will be evaluated through questionnaires and focus-group interviews examining perceptions of comfort, safety, usability, and perceived impact on work performance. Qualitative interviews with workers and relevant stakeholders will also explore experiences with implementation, barriers and facilitators to adoption, and how the exoskeleton fits into daily work routines.
An additional objective of the study is to evaluate the economic implications of implementing occupational exoskeletons in a logistics workplace. The costs associated with acquiring and implementing the devices, including training and operational resources, will be compared with potential economic benefits such as reduced sickness absence, lower employee turnover, and maintained or improved productivity. These analyses will provide estimates of cost-effectiveness and return on investment from both company and societal perspectives.
In addition to quantitative outcome analyses, qualitative data from focus-group interviews will be analyzed using thematic analysis to identify key themes related to user experiences, implementation processes, and contextual factors affecting exoskeleton adoption. Integrating qualitative and quantitative findings will provide a more comprehensive understanding of how occupational exoskeletons function in real-world settings and how they may influence both workers and organizations.
The RELAX project addresses an important gap in occupational health research by evaluating the long-term effects of exoskeleton use in an authentic workplace environment. Many previous studies have focused primarily on short-term biomechanical outcomes measured in controlled laboratory settings. By contrast, this study evaluates the broader impacts of exoskeleton implementation, including worker well-being, organizational outcomes, and economic considerations.
The findings of this study may contribute valuable evidence for employers, occupational health professionals, technology developers, and policymakers interested in improving working conditions in physically demanding industries. If passive back-support exoskeletons prove to reduce physical strain and improve worker well-being without negatively affecting productivity, they may represent a promising ergonomic intervention for preventing work-related musculoskeletal disorders in the logistics sector and other industries involving manual material handling.
Conversely, if the study identifies limitations, unintended effects, or barriers to successful implementation, these findings will also be important for guiding future research, device development, and workplace policy decisions. Overall, the RELAX project seeks to generate robust real-world evidence on the effectiveness, feasibility, and sustainability of occupational exoskeletons as a workplace intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a controlled parallel-group workplace intervention study conducted over 18 months. Two comparable warehouse departments will be followed simultaneously: one department will implement a passive back-support exoskeleton during regular work tasks, while the other will continue usual practice without exoskeleton use. Allocation occurs at department level and is not randomized. All eligible full-time employees in both departments will be invited to participate and will be observed throughout the study period. Outcomes will be assessed repeatedly during follow-up using questionnaires and company records, allowing comparison of changes over time between the intervention and control groups under real-world working conditions.
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton group | Experimental | Device: Use of an occupational passive back-exoskeletonGroup receiving intervention |
| Control Group | No intervention | –Group receiving no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-65 years at enrolment
- full-time employment in the current work department
- no major pain or injuries affecting daily work tasks
Key exclusion criteria (4 listed)
- anthropometric characteristics preventing adequate fit of the exoskeleton
- part-time employment
- pregnancy or anticipated prolonged absence from work during the study period (standard vacation not included)
- If a participating worker from either the intervention or control group transfers to another department within the company during the intervention period for reasons unrelated to the intervention, the participant will be excluded from the study. Such cases will be classified as dropouts and the corresponding data will be reported as lost to follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of an occupational passive back-exoskeletonUse of the IX Back AIR (SuitX by Ottobock) for 18 months during daily order picking tasks | Device | Exoskeleton group |
Primary outcome
Perceived Work Intensity
Time frame: Reported at baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18.
Assessed using two 10-point Likert-scale questions on 1) how much they exert themselves during a shift and 2) how exhausted they feel at the end of a shift.
Musculoskeletal Discomfort
Time frame: Reported at baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18.
Assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), completed monthly by workers as part of the questionnaire battery. The questionnaire includes three questions on 1) how often they experienced discomfort during the last workweek (1-5, 5 being worst), 2) how uncomfortable it was (1-3, 3 being worst), and 3) if the discomfort interfered with their ability to work (1-3, 3 being worst). All questions will be answered for separate body regions. Analyses will primarily focus on reports of back discomfort.
3 secondary outcomes
Sickness Absence
Time frame: Reported at baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18.
Employee Turnover
Time frame: Time-to-event. Reported as the timepoint (in months) from baseline, when the resignation occurs.
Productivity
Time frame: Weekly during the 18-month intervention (Baseline to month 18).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background1) J De Kok. Work-related musculoskeletal disorders: prevalence, costs and demographics in the EU European Risk Observatory Report. European Agency for Safety and Health at Work (2019) EU OSHA.
- Background: PubMed 33340719Skals S, Blafoss R, Andersen MS, de Zee M, Andersen LL. Manual material handling in the supermarket sector. Part 1: Joint angles and muscle activity of trapezius descendens and erector spinae longissimus. Appl Ergon. 2021 Apr;92:103340. doi: 10.1016/j.apergo.2020.103340. Epub 2020 Dec 16.
- Background: PubMed 16595438Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.
- Background: PubMed 40566433Popova MS, Nikolova SP, Filkova SI. Demographic and Occupational Determinants of Work-Related Musculoskeletal Disorders: A Cross-Sectional Study. J Funct Morphol Kinesiol. 2025 Apr 20;10(2):137. doi: 10.3390/jfmk10020137.
- Background: PubMed 22231424Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
- Background6) S Toxiri, MB Näf, M Lazzaroni, J Fernández, M Sposito, T Poliero, et al. Back-Support Exoskeletons for Occupational Use: An Overview of Technological Advances and Trends, IISE Transactions on Occupational Ergonomics and Human Factors. 7 (2019) 237.
- Background7) H Kazerooni, W Tung, M Pillai. Evaluation of Trunk-Supporting Exoskeleton, Proceedings of the Human Factors and Ergonomics Society Annual Meeting. 63 (2019) 1080.
- Background: PubMed 38486625Crea S, Beckerle P, De Looze M, De Pauw K, Grazi L, Kermavnar T, Masood J, O'Sullivan LW, Pacifico I, Rodriguez-Guerrero C, Vitiello N, Ristic-Durrant D, Veneman J. Occupational exoskeletons: A roadmap toward large-scale adoption. Methodology and challenges of bringing exoskeletons to workplaces. Wearable Technol. 2021 Sep 17;2:e11. doi: 10.1017/wtc.2021.11. eCollection 2021.
- Background: PubMed 31828844Howard J, Murashov VV, Lowe BD, Lu ML. Industrial exoskeletons: Need for intervention effectiveness research. Am J Ind Med. 2020 Mar;63(3):201-208. doi: 10.1002/ajim.23080. Epub 2019 Dec 11.
- Background: PubMed 37146320Kranenborg SE, Greve C, Reneman MF, Roossien CC. Side-effects and adverse events of a shoulder- and back-support exoskeleton in workers: A systematic review. Appl Ergon. 2023 Sep;111:104042. doi: 10.1016/j.apergo.2023.104042. Epub 2023 May 3.
- Background11) J Theurel, K Desbrosses. Occupational exoskeletons: overview of their benefits and limitations in preventing work-related musculoskeletal disorders. IISE Transactions on Occupational Ergonomics and Human Factors. 7 (2019) 264-280.
- Background12) MA Nussbaum, BD Lowe, M De Looze, C Harris-Adamson, M Smets. An Introduction to the Special Issue on Occupational Exoskeletons, IISE Transactions on Occupational Ergonomics and Human Factors. 7 (2020) 153.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pascal Madeleine, Professor study director
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of an occupational passive back-exoskeleton in people with Work-Related Musculoskeletal Disorders, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lasse S. Jakobsen, PhD (0045 72332998, lsja@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Work Intensity (time frame: Reported at baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07561112, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.