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临床试验/NCT07561112
NCT07561112尚未招募不适用

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

Aalborg University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Musculoskeletal Discomfort

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18-65 years at enrolment
  • full-time employment in the current work department
  • no major pain or injuries affecting daily work tasks

排除标准

  • 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.

研究组 & 干预措施

Control Group

No Intervention

Group receiving no intervention

Exoskeleton group

Experimental

Group receiving intervention

干预措施: Use of an occupational passive back-exoskeleton (Device)

结局指标

主要结局

Musculoskeletal Discomfort

时间窗: 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.

Perceived Work Intensity

时间窗: 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.

次要结局

  • Sickness Absence(Reported at baseline, Month 3, Month 6, Month 9, Month 12, Month 15, and Month 18.)
  • Employee Turnover(Time-to-event. Reported as the timepoint (in months) from baseline, when the resignation occurs.)
  • Productivity(Weekly during the 18-month intervention (Baseline to month 18).)

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lasse Schrøder Jakobsen

PostDoc researcher

Aalborg University

研究点 (1)

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