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| Name | Class |
|---|---|
| Audi AG | INDUSTRY |
| BASF | INDUSTRY |
| BMW AG | INDUSTRY |
| Dachser Intelligent Logistics |
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BACKGROUND Industrial tasks that are characterized by high loads, a high repetition rate, and/or awkward body postures, put employees at higher risk to develop work-related musculoskeletal disorders (WRMSD), especially low back pain. To counteract the prevalence of WRMSD, human-robot interaction could improve the power of a person and reduce the physical strain. For the lower back, a reduction of spinal loading could be helpful. The passive upper-extremity exoskeleton Laevo® is developed to support physically heavy work: it supports the back during bending and should, consequently, result in less low back pain (Laevo®, the Netherlands).
OBJECTIVES The primary aim of this study is to assess to what extent wearing the exoskeleton changes:
Secondary aims of this study are to assess to what extent wearing the exoskeleton changes:
METHODS Different experiments will be performed.
ANALYSES Depending on the outcome parameter, different analyses will be performed including a various number of independent variables.
DATA PROTECTION All participating subjects will receive a refund of € 45 after study completion. Subjects will sign an informed consent and their data will be numerically pseudonymized to guarantee anonymity.
SIMULATED TASKS
IMPORTANT NOTE --- On this platform, results of the static sorting task ONLY will be reported. Results of other parts of the study will be reported in the respective publication. Links to these publications will be added as soon as they are published and available. --- IMPORTANT NOTE
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With exoskeleton, then without exoskeleton | Experimental | Subject will first perform the conditions (simulated, simplified, industrial standing work) with the exoskeleton, then without the exoskeleton. |
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| Without exoskeleton, then with exoskeleton | Experimental | Subject will first perform the conditions (simulated, simplified, industrial standing work) without the exoskeleton, then with the exoskeleton. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laevo ® | Device | A passive exoskeleton supporting the lower back during bending and lifting tasks (for more information, visit the manufacturer's website: http://en.laevo.nl/). |
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| Measure | Description | Time Frame |
|---|---|---|
| Muscular Activity of Erector Spinae Muscle. | Root-mean-square (RMS) of the electrical activity of the erector spinae muscle using surface electromyography (sEMG). The sEMG signals will be continuously recorded, and the RMS will be normalized to a maximal voluntary contraction (%MVE) and averaged over the time period of each experimental condition. | Average RMS-value (%MVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition |
| Muscular Activity of Biceps Femoris Muscle. | Root-mean-square (RMS) of the electrical activity of the biceps femoris muscle using surface electromyography (sEMG). The sEMG signals will be continuously recorded, and the RMS will be normalized to a reference voluntary contraction (%RVE) and averaged over the time period of each experimental condition. | Average RMS-value (%RVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition |
| Posture (Thoracic Kyphosis) | The posture of the upper spine (thoracic kyphosis) determined using 2D gravimetric position sensors placed on the thoracic vertebrae T1 and lumbar vertebrae L1. The difference value between both sensors reflects the thoracic kyphosis, which was averaged over each experimental condition. | Average thoracic kyphosis over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
| Posture (Lumbar Lordosis) | The posture of the lower spine (lumbar lordosis) determined using 2D gravimetric position sensors placed on the lumbar vertebrae L1 and L5. The difference value between both sensors reflects the lumbar lordosis, which was averaged over each experimental condition. | Average lumbar lordosis over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
| Posture (Trunk Flexion) |
| Measure | Description | Time Frame |
|---|---|---|
| Muscular Activity of Rectus Abdominis, Vastus Lateralis, Gastrocnemius Medialis and Trapezius Descendens Muscles. | Root-mean-square (RMS) of the electrical activity of the rectus abdominis, vastus lateralis, gastrocnemius medialis and trapezius descendens muscles using surface electromyography (sEMG). The sEMG signals will be continuously recorded, and the RMS will be normalized to a refeernce voluntary contraction (%RVE) and averaged over the time period of each experimental condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Occupational and Social Medicine and Health Services Research, University Hospital Tübingen | Tübingen | Baden-Wurttemberg | 72074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33861139 | Result | Luger T, Bar M, Seibt R, Rieger MA, Steinhilber B. Using a Back Exoskeleton During Industrial and Functional Tasks-Effects on Muscle Activity, Posture, Performance, Usability, and Wearer Discomfort in a Laboratory Trial. Hum Factors. 2023 Feb;65(1):5-21. doi: 10.1177/00187208211007267. Epub 2021 Apr 16. | |
| 34280658 | Result |
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39 volunteering participants were recruited, of which 2 were excluded from the study prior to the measurement due to a too high BMI (> 30 kg/m2). A 3rd participant was excluded because he was the first that was measured and we had to adjust a few things to the measurement afterwards.
Volunteering participants were recruited via the collaborating investigators and by means of announcement e-mails to employees and students of the University and Hospital of Tübingen.
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| ID | Title | Description |
|---|---|---|
| FG000 | First With Exoskeleton Then Without Exoskeleton | Subject will perform the conditions (simulated, simplified, industrial standing work) as described under "model description" first with and then without the exoskeleton. |
| FG001 | First Without Exoskeleton Then With Exoskelton | Subject will perform the conditions (simulated, simplified, industrial standing work) as described under "model description" first without and then with the exoskeleton. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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On the pre-measurement assessment, all volunteering participants were screened for eligability and basic information was collected, such as age.
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| ID | Title | Description |
|---|---|---|
| BG000 | With Exoskeleton, Then Without Exoskeleton | Subject first performed the conditions (simulated, simplified, industrial standing work) with the exoskeleton, then without the exoskeleton. |
| BG001 | Without Exoskeleton, Then With Exoskeleton |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Muscular Activity of Erector Spinae Muscle. | Root-mean-square (RMS) of the electrical activity of the erector spinae muscle using surface electromyography (sEMG). The sEMG signals will be continuously recorded, and the RMS will be normalized to a maximal voluntary contraction (%MVE) and averaged over the time period of each experimental condition. | The results of the effect of wearing the exoskeleton during the static task are reported below, without taking into account the working direction (frontal or lateral, i.e. without or with trunk rotation, respectively). Note: the overall number of participants analyzed deviates in the first arm because data of one subject was excluded. | Posted | Median | Inter-Quartile Range | %MVE | Average RMS-value (%MVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition |
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One hour for each intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | With Exoskeleton | Subjects performed the conditions (simulated, simplified, industrial standing work) with the exoskeleton. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tessy Luger | Institute of Occupational and Social Medicine and Health Services Research | 004970712984364 | Tessy.Luger@med.uni-tuebingen.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2019 | Dec 3, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 6, 2018 | Jan 23, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067190 | Exoskeleton Device |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Daimler AG | INDUSTRY |
| Deutsche Post AG | INDUSTRY |
| Iturri Gruppe | INDUSTRY |
| MTU Aero Engines AG | INDUSTRY |
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Subjects and experimenters will not be blinded, because it will be obvious which task will be performed by the subjects and measurements need to be tracked by the experimenter.
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| No Laevo ® | Device | The subjects will not wear any supporting device to perform the experiment, which serves as the control condition. |
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The posture of the trunk determined using a 2D gravimetric position sensor placed on the thoracic vertebrae T10. The flexion angle of the sensor was averaged over each experimental condition. |
| Average trunk flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
| Posture (Hip Flexion) | The posture of the hip (hip flexion) determined using 2D gravimetric position sensors placed on the lumbar vertebrae L5 and the upper leg (femur). The difference value between both sensors reflects the hip flexion, which was averaged over each experimental condition. | Average hip flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
| Posture (Knee Flexion) | The posture of the knee (knee flexion) determined using 2D gravimetric position sensors placed on the upper leg (femur) and lower leg (tibia). The difference value between both sensors reflects the knee flexion, which was averaged over each experimental condition. | Average knee flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
| Knee Compression Force | The knee compression force (KCF) is calculated using 2D inverse modelling with continuous recordings from 2D gravimetric position sensors (for joint angles) and a force plate (for ground reaction forces). The average knee compression force will be calculated over each experimental condition and summarized for both the left and right knee, since the task is executed in the frontal plane. | Average knee compression force (KCF) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition |
| Average RMS-value (%RVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition. |
| Rating of Perceived Discomfort (RPD) | Discomfort (RPD) was assessed using an 11-point numeric rating scale (NRS), ranging from 0 (no discomfort at all) to 10 (maximally imaginable discomfort). It was assessed directly before (0 min) and directly after (1.5 min) each experimental condition. The experimental conditions consisted of either static or dynamic tasks, that lasted up to 1.5 minutes. | Change from baseline (0 min) to directly after (1.5 min) both experimental conditions |
| Heart Rate | Continuous recording electrocardiography allows calculating the heart rate, a parameter reflecting the central stress state of the participant. The average heart rate will be calculated per time period. | Average heart activity over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
| Evaluation of Workload | The NASA Task Load Index (TLX) of Hart and Staveland (1988) will be used to evaluate workload. This standardized tool contains six dimensions (mental demand, physical demand, temporal demand, own performance, effort, frustration), of which each scale ranges from from 0 (low) to 100 (high). We will include three dimensions of interest, i.e. physical demand, temporal demand, effort, and calculate the unweighted average of the score of these three dimensions (Hoonakker et al. 2011). | Directly after the experimental condition during which the exoskeleton was worn (~ 4.5-6.5 min) |
| Self-developed Participant Evaluation Questionnaire | This questionnaire will consist of questions about usability and acceptance of the intervention (the Laevo device), stemming from standardized questions from existing questionnaires, including:
The questionnaire can only be filled out after the condition within which the technology (here: exoskeleton) was used. That means that results are only provided and, thus, reported from the arm "with exoskeleton". | Directly after the experiment (~2.5 hours) |
| Luger T, Bar M, Seibt R, Rimmele P, Rieger MA, Steinhilber B. A passive back exoskeleton supporting symmetric and asymmetric lifting in stoop and squat posture reduces trunk and hip extensor muscle activity and adjusts body posture - A laboratory study. Appl Ergon. 2021 Nov;97:103530. doi: 10.1016/j.apergo.2021.103530. Epub 2021 Jul 16. |
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Subject first performed the conditions (simulated, simplified, industrial standing work) without the exoskeleton, then with the exoskeleton. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | cm |
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| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
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Subjects first performed the conditions (simulated, simplified, industrial standing work) with the exoskeleton, then without the exoskeleton.
| OG001 | Without Exoskeleton, Then With Exoskeleton | Subjects first performed the conditions (simulated, simplified, industrial standing work) without the exoskeleton, then with the exoskeleton. |
|
|
| Primary | Muscular Activity of Biceps Femoris Muscle. | Root-mean-square (RMS) of the electrical activity of the biceps femoris muscle using surface electromyography (sEMG). The sEMG signals will be continuously recorded, and the RMS will be normalized to a reference voluntary contraction (%RVE) and averaged over the time period of each experimental condition. | The results of the effect of wearing the exoskeleton during the static task are reported below, without taking into account the working direction (frontal or lateral, i.e. without or with trunk rotation, respectively). | Posted | Median | Inter-Quartile Range | %RVE | Average RMS-value (%RVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition |
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|
|
| Primary | Posture (Thoracic Kyphosis) | The posture of the upper spine (thoracic kyphosis) determined using 2D gravimetric position sensors placed on the thoracic vertebrae T1 and lumbar vertebrae L1. The difference value between both sensors reflects the thoracic kyphosis, which was averaged over each experimental condition. | Posted | Median | Inter-Quartile Range | degrees | Average thoracic kyphosis over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
|
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|
| Primary | Posture (Lumbar Lordosis) | The posture of the lower spine (lumbar lordosis) determined using 2D gravimetric position sensors placed on the lumbar vertebrae L1 and L5. The difference value between both sensors reflects the lumbar lordosis, which was averaged over each experimental condition. | Posted | Median | Inter-Quartile Range | degrees | Average lumbar lordosis over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
|
|
|
| Primary | Posture (Trunk Flexion) | The posture of the trunk determined using a 2D gravimetric position sensor placed on the thoracic vertebrae T10. The flexion angle of the sensor was averaged over each experimental condition. | Posted | Median | Inter-Quartile Range | degrees | Average trunk flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
|
|
|
| Primary | Posture (Hip Flexion) | The posture of the hip (hip flexion) determined using 2D gravimetric position sensors placed on the lumbar vertebrae L5 and the upper leg (femur). The difference value between both sensors reflects the hip flexion, which was averaged over each experimental condition. | Posted | Median | Inter-Quartile Range | degrees | Average hip flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
|
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|
| Primary | Posture (Knee Flexion) | The posture of the knee (knee flexion) determined using 2D gravimetric position sensors placed on the upper leg (femur) and lower leg (tibia). The difference value between both sensors reflects the knee flexion, which was averaged over each experimental condition. | Posted | Median | Inter-Quartile Range | degrees | Average knee flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
|
|
|
| Primary | Knee Compression Force | The knee compression force (KCF) is calculated using 2D inverse modelling with continuous recordings from 2D gravimetric position sensors (for joint angles) and a force plate (for ground reaction forces). The average knee compression force will be calculated over each experimental condition and summarized for both the left and right knee, since the task is executed in the frontal plane. | For some of the participants, we could not analyze the knee compression force (KCF) data, because some information was missing to apply the modelling procedure. | Posted | Median | Inter-Quartile Range | N | Average knee compression force (KCF) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition |
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| Secondary | Muscular Activity of Rectus Abdominis, Vastus Lateralis, Gastrocnemius Medialis and Trapezius Descendens Muscles. | Root-mean-square (RMS) of the electrical activity of the rectus abdominis, vastus lateralis, gastrocnemius medialis and trapezius descendens muscles using surface electromyography (sEMG). The sEMG signals will be continuously recorded, and the RMS will be normalized to a refeernce voluntary contraction (%RVE) and averaged over the time period of each experimental condition. | Posted | Median | Inter-Quartile Range | %RVE | Average RMS-value (%RVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition. |
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|
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| Secondary | Rating of Perceived Discomfort (RPD) | Discomfort (RPD) was assessed using an 11-point numeric rating scale (NRS), ranging from 0 (no discomfort at all) to 10 (maximally imaginable discomfort). It was assessed directly before (0 min) and directly after (1.5 min) each experimental condition. The experimental conditions consisted of either static or dynamic tasks, that lasted up to 1.5 minutes. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline (0 min) to directly after (1.5 min) both experimental conditions |
|
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| Secondary | Heart Rate | Continuous recording electrocardiography allows calculating the heart rate, a parameter reflecting the central stress state of the participant. The average heart rate will be calculated per time period. | Posted | Mean | Standard Deviation | beats per minute | Average heart activity over time period baseline (0 min) to directly after (1.5 min) the experimental condition |
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| Secondary | Evaluation of Workload | The NASA Task Load Index (TLX) of Hart and Staveland (1988) will be used to evaluate workload. This standardized tool contains six dimensions (mental demand, physical demand, temporal demand, own performance, effort, frustration), of which each scale ranges from from 0 (low) to 100 (high). We will include three dimensions of interest, i.e. physical demand, temporal demand, effort, and calculate the unweighted average of the score of these three dimensions (Hoonakker et al. 2011). | Posted | Mean | Standard Deviation | units on a scale | Directly after the experimental condition during which the exoskeleton was worn (~ 4.5-6.5 min) |
|
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| Secondary | Self-developed Participant Evaluation Questionnaire | This questionnaire will consist of questions about usability and acceptance of the intervention (the Laevo device), stemming from standardized questions from existing questionnaires, including:
The questionnaire can only be filled out after the condition within which the technology (here: exoskeleton) was used. That means that results are only provided and, thus, reported from the arm "with exoskeleton". | Reportedin units on a scale: SUS: 0 (low usability) to 100 (high usability) TUI-userfriendliness: 3 (totaly not applicable) to 21 (totally applicable) TUI-scepticism: 4 (totaly not applicable) to 28 (totaly applicable) | Posted | Mean | Standard Deviation | units on a scale | Directly after the experiment (~2.5 hours) |
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| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Without Exoskeleton | Subjects performed the conditions (simulated, simplified, industrial standing work) without the exoskeleton. | 0 | 36 | 0 | 36 | 0 | 36 |
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| Gastrocnemius Medialis |
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| Trapezius Descendens |
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| Effort |
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