N/A
N=39
Work Physiological-Biomechanical Analysis of a Passive Exoskeleton to Support Occupational Lifting and Flexing Processes
Passive Upper-limb Exoskeleton
Bottom Line
View on ClinicalTrials.gov: NCT03725982 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Muscular Activity of Erector Spinae Muscle. — 11.2; 11.1; 12.3; 10.4 %MVE
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laevo ® (Device); No Laevo ® (Device)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University Hospital Tuebingen
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Muscular Activity of Erector Spinae Muscle. |
11.2; 11.1; 12.3; 10.4 | — |
| PRIMARY Muscular Activity of Biceps Femoris Muscle. |
26.6; 38.7; 35.8; 31.3 | — |
| PRIMARY Posture (Thoracic Kyphosis) |
12.0; 15.4; 14.5; 13.9 | — |
| PRIMARY Posture (Lumbar Lordosis) |
11.8; 13.2; 12.2; 13.3 | — |
| PRIMARY Posture (Trunk Flexion) |
38.5; 39.6; 37.9; 39.9 | — |
| PRIMARY Posture (Hip Flexion) |
39.9; 33.1; 29.8; 40.4 | — |
| PRIMARY Posture (Knee Flexion) |
16.4; 11.7; 9.0; 17.9 | — |
| PRIMARY Knee Compression Force |
845; 742; 807; 874 | — |
| SECONDARY Muscular Activity of Rectus Abdominis, Vastus Lateralis, Gastrocnemius Medialis and Trapezius Descendens Muscles. |
1.85; 1.57; 3.85; 3.35; 54.11; 54.11 | — |
| SECONDARY Rating of Perceived Discomfort (RPD) |
0.3; 0.2; 0.5; 0.2 | — |
| SECONDARY Heart Rate |
85.29; 83.16 | — |
| SECONDARY Evaluation of Workload |
2.31; 1.67; 1.10; 0.88; 2.10; 1.49 | — |
| SECONDARY Self-developed Participant Evaluation Questionnaire |
75.44; 17.92; 11.53 | — |
Summary
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:
* muscular activity of the erector spinae and biceps femoris muscles;
* knee compression force;
* posture of the upper and lower spine, trunk, hips and knees; ...in different tasks (static vs. dynamic), different trunk postures (trunk flexion vs. trunk flexion and rotation) and different knee postures (straight vs. stooped).
Secondary aims of this study are to assess to what extent wearing the exoskeleton changes:
* muscular activity of the trapezius descendens, rectus abdominis, vastus medialis and gastrocnemius medialis;
* perceived discomfort;
* heart rate;
* internal loadings on the spine, using a lumbar spine model;
* the performance of subjects during functional activities (e.g., stair climbing) when wearing the exoskeleton (either turned on or off); ...in different tasks (static vs. dynamic), different trunk postures (trunk flexion vs. trunk flexion and rotation), different knee postures (stoop vs. squat), and different static holding positions(0° vs. 30° vs. 60°) with different weights (0kg vs. 8kg vs. 16kg).
Eligibility Criteria
Inclusion Criteria
- The participant will give his voluntary informed consent after receiving oral and written information of the content and goal of the study.
Exclusion Criteria
- Aged 40 years;
- Female;
- BMI > 30 kg/m2;
- People under the influence of intoxicants, analgesics, or muscle relaxants;
- Alcohol abuse;
- People with cardiovascular diseases;
- People with a heart pacemaker;
- People with a disability who, due to their restriction at a workplace of this kind, will not be able to participate;
- People with Diabetes Mellitus;
- People with severe muscle contractions of the lower extremities, back or arms;
- People with acute ailments or pain;
- People who are unable to complete the examination program due to language or cognitive obstacles;
- Depending on the degree of severity, people with diseases of the veins and joints of the lower extremities, spine, muscle disorders, symptomatic neurological-psychiatric diseases, acute pain syndromes, maladies or other current diseases.
Data sourced from ClinicalTrials.gov (NCT03725982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.