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

NCT05890300 | Completed DMC

• 1 other identifier: AAU-LBK1083
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Work-related Musculoskeletal Disorders

Keywords

Exoskeleton; Ergonomics; Manual materials handling

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.

Secondary Outcomes (6)

• Perceived effort

  Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.

• Comfort and Performance

  Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.

• Liking

  Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.

• Exertion

  Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.

• Musculoskeletal discomfort

  Pre-test (baseline) initial to the 24-week randomized controlled trial, and post-test subsequent the 24-week randomized controlled trial.

Other Outcomes (1)

• Self-reporting of exoskeleton-use during the 24-week trial

  Reported every week up to 24 weeks of the intervention

Study Arms (2)

Intervention (INT)

EXPERIMENTAL

Group receiving intervention

Device: Use of an occupational passive back-exoskeleton

Control (CON)

NO INTERVENTION

Group receiving no intervention

Interventions

Use of an occupational passive back-exoskeleton DEVICE

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.

Intervention (INT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• I) body compositions unable to fit the exoskeleton (bad fit). II) part-time workers. III) previous low-back injury

Sponsors & Collaborators

• Aalborg University: lead
• Dagrofa Logistics A/S: collaborator

Study Sites (1)

Aalborg University

Gistrup, 9260, Denmark

Location

Related Publications (15)

• 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.

  PMID: 33340719 BACKGROUND

• Liberty Mutual Insurance. 2020. 2020 Workplace Safety Index: The Top 10 Causes of Disabling Injuries

  BACKGROUND

• GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.

  PMID: 30496104 BACKGROUND

• Arbejdstilsynets erhvervssygdomsregister og Danmarks Statistiks Registerbaserede Arbejdsstyrke-statistik (RAS). De anmeldte erhvervssygdomme inden for branchegruppen "kontor" omfatter, ud over administrativt arbejde, også anmeldelser knyttet til fx social-og sundhedsarbejde samt omsorgs- og pædagogarbejde, hvis arbejdsgiveren er registreret som kommunal administration i stedet for fx plejehjem eller daginstitutioner.

  BACKGROUND

• Arbejdsskadestatistik (2019). Arbejdsmarkedets Erhvervsforsikring.

  BACKGROUND

• Peters, M. & Wischniewski, S. (2019). The impact of using exoskeletons on occupational safety and health. Federal Institute for Occupational Safety and Health.

  BACKGROUND

• Ingeniøren (2019). Første exoskeletter på vej ud i danske industrivirksomheder.

  BACKGROUND

• Theurel, J. & Desbrosses, K. (2019). Occupational exoskeletons: Overview of their benefits and limitations in preventing work-related musculoskeletal disorders. IISE Transactions on Occupational Ergonomics and Human Factors. Volume 7, Issue 3-4, p. 264-280.

  BACKGROUND

• Theurel J, Desbrosses K, Roux T, Savescu A. Physiological consequences of using an upper limb exoskeleton during manual handling tasks. Appl Ergon. 2018 Feb;67:211-217. doi: 10.1016/j.apergo.2017.10.008. Epub 2017 Oct 16.

  PMID: 29122192 BACKGROUND

• de Looze MP, Bosch T, Krause F, Stadler KS, O'Sullivan LW. Exoskeletons for industrial application and their potential effects on physical work load. Ergonomics. 2016 May;59(5):671-81. doi: 10.1080/00140139.2015.1081988. Epub 2015 Oct 7.

  PMID: 26444053 BACKGROUND

• Hondzinski JM, Ikuma L, de Queiroz M, Wang C. Effects of exoskeleton use on movement kinematics during performance of common work tasks: A case study. Work. 2018;61(4):575-588. doi: 10.3233/WOR-162827.

  PMID: 30507598 BACKGROUND

• Park JH, Kim S, Nussbaum MA, Srinivasan D. Effects of two passive back-support exoskeletons on postural balance during quiet stance and functional limits of stability. J Electromyogr Kinesiol. 2021 Apr;57:102516. doi: 10.1016/j.jelekin.2021.102516. Epub 2021 Jan 19.

  PMID: 33493784 BACKGROUND

• Kim S, Nussbaum MA, Smets M. Usability, User Acceptance, and Health Outcomes of Arm-Support Exoskeleton Use in Automotive Assembly: An 18-month Field Study. J Occup Environ Med. 2022 Mar 1;64(3):202-211. doi: 10.1097/JOM.0000000000002438.

  PMID: 34873132 BACKGROUND

• Kim 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.

  PMID: 34363229 BACKGROUND

• Hedge, A., Morimoto, S., & McCrobie, D. (1999). Cornell musculoskeletal discomfort questionnaire. Ergonomics

  BACKGROUND

Study Officials

• Pascal Madeleine, Professor

  Aalborg University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants will complete two test sessions: 1) a pre-test (baseline), and 2) a post-test conducted after the 24-week trial. Participants will be allocated to either an experimental group or a control group. The experimental group will conduct a 24-week intervention, while the control group will receive no intervention. Participants are randomized to an experimental group (EXP) or a control group (CON) stratified for age, gender, and work experience. Participants allocated to the EXP will use a passive- back exoskeleton during more than 50 % of their working hours for 24 weeks. CON will be instructed to resume their normal working routine throughout the study period. Both groups will attend weekly meetings and will fill out questionnaires every fourth week.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: June 6, 2023
• Study Start: September 20, 2023
• Primary Completion: May 20, 2024
• Study Completion: September 20, 2024
• Last Updated: February 3, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)