Work-related Musculoskeletal Disorders Clinical Trial
— EXO4MMHOfficial title:
Effectiveness of an Occupational Back-exoskeleton on the Biomechanical Load in Manual Materials Handling - A Randomized Controlled Trial.
Verified date | January 2024 |
Source | Aalborg University |
Contact | Jakobsen |
Phone | +4572332998 |
lsja[@]hst.aau.dk | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 20, 2024 |
Est. primary completion date | February 20, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University | Gistrup |
Lead Sponsor | Collaborator |
---|---|
Aalborg University | Dagrofa Logistics A/S |
Denmark,
Arbejdsskadestatistik (2019). Arbejdsmarkedets Erhvervsforsikring.
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.
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Self-reporting of exoskeleton-use during the 24-week trial | 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 | |
Primary | 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 | Perceived effort | 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. | |
Secondary | Comfort and Performance | 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. | |
Secondary | Liking | 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. | |
Secondary | Exertion | 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. | |
Secondary | Musculoskeletal discomfort | 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. | |
Secondary | Productivity | 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. |
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