About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
age 18-65 years at enrolment
full-time employment in the current work department
no major pain or injuries affecting daily work tasks
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Use of an occupational passive back-exoskeleton
DeviceUse of the IX Back AIR (SuitX by Ottobock) for 18 months during daily order picking tasks
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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?"
Employee Turnover
Measured as the number of monthly resignations in the respective department as reported by the company.
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.
Other outcomes
Exoskeleton evaluation / User acceptance
Evaluations of the exoskeleton will be conducted using a 6-item 10-point Liker-Scale questionnaire: Q1: What is your perception of the overall fit and comfort of the exoskeleton when performing your job? Q2: What is your perception of the thermal comfort typically (and/or feelings of sweatiness) when using the exoskeleton? Q3: What is your perception of balance (or any sense of imbalance) while using the exoskeleton? Q4: Do you feel that your range of motion was at all limited while using the exoskeleton? Q5: When using the exoskeleton to perform your job, how do you think this affected your overall safety? Q6: Overall, does using the exoskeleton positively or negatively affect your performance? Additionally, the questionnaire will include the open-ended questions: Q7: What do you most like about the exoskeleton? Q8: What do you least like about the exoskeleton? Q9: If you could change anything about the exoskeleton, what would you change?
Process evaluation
A process evaluation will be conducted to support interpretation of the intervention outcomes and to document implementation fidelity, user acceptance, and contextual factors influencing exoskeleton use. Process evaluation data will be collected every 6th month throughout the 18-month intervention period. Qualitative process data will be collected through repeated focus-group interviews with workers from the intervention group and with relevant stakeholders. The interviews will explore experiences with BSE use, integration into daily work routines, perceived benefits and drawbacks, and organizational factors affecting implementation.
Exoskeleton use
During the intervention period, workers will report daily exoskeleton use using operational logs. Specifically, usage will be recorded through a stamp system each time the exoskeleton is used. In this study exoskeleton use will be reported as a weekly average.
Sponsors and contacts
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Aalborg University
Lead sponsor
National Research Centre for the Working Environment, Denmark
Collaborator
Aarhus University Hospital
Collaborator
Royal College of Surgeons, Ireland
Collaborator
Ecole Normale Supérieure de Rennes
Collaborator
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