CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Laevo ® +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03725982
NCT03725982N/ACompleted

Work Physiological-Biomechanical Analysis of a Passive Exoskeleton to Support Occupational Lifting and Flexing Processes

University Hospital Tuebingen·interventional·Posted Oct 31, 2018·Updated Jul 12, 2023

In Brief

A clinical study evaluating Laevo ® and No Laevo ® for Passive Upper-limb Exoskeleton. Completed, enrolled 39 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 31, 2018
Enrollment StartJan 18, 2019
Primary CompletionMay 15, 2019
Study CompletionMay 22, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.7 years ago

Interventions

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/).

No Laevo ®device

The subjects will not wear any supporting device to perform the experiment, which serves as the control condition.