Trial · NCT03725982

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

NCT03725982, Not applicable, Completed, University Hospital Tuebingen; results first posted 2020-03-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Work Physiological-Biomechanical Analysis of a Passive Exoskeleton to Support Occupational Lifting and Flexing Processes. Trials, record NCT03725982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03725982

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Work Physiological-Biomechanical Analysis of a Passive Exoskeleton to Support Occupational Lifting and Flexing Processes
NCT number: NCT03725982
Status: Completed
Phases: Not applicable
Enrollment: 39 participants, actual
Lead sponsor: University Hospital Tuebingen
Conditions: Passive Upper-limb Exoskeleton
Interventions: Laevo ®, No Laevo ®
First posted: 2018-10-31
Last updated: 2023-07-12
Results first posted: 2020-03-31

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Muscular Activity of Erector Spinae Muscle.	Average RMS-value (%MVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition	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.
Primary	Muscular Activity of Biceps Femoris Muscle.	Average RMS-value (%RVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition	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.
Primary	Posture (Thoracic Kyphosis)	Average thoracic kyphosis over time period baseline (0 min) to directly after (1.5 min) the experimental condition	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.
Primary	Posture (Lumbar Lordosis)	Average lumbar lordosis over time period baseline (0 min) to directly after (1.5 min) the experimental condition	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.
Primary	Posture (Trunk Flexion)	Average trunk flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition	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.
Primary	Posture (Hip Flexion)	Average hip flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition	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.
Primary	Posture (Knee Flexion)	Average knee flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition	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.
Primary	Knee Compression Force	Average knee compression force (KCF) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition	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.
Secondary	Muscular Activity of Rectus Abdominis, Vastus Lateralis, Gastrocnemius Medialis and Trapezius Descendens Muscles.	Average RMS-value (%RVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition.	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.
Secondary	Rating of Perceived Discomfort (RPD)	Change from baseline (0 min) to directly after (1.5 min) both experimental conditions	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.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Muscular Activity of Erector Spinae Muscle.	Average RMS-value (%MVE) over the time period running from baseline (0 min) to directly after (1.5 min) the 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.	%MVE	MEDIAN
PRIMARY	Muscular Activity of Biceps Femoris Muscle.	Average RMS-value (%RVE) over the time period running from baseline (0 min) to directly after (1.5 min) the 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).	%RVE	MEDIAN
PRIMARY	Posture (Thoracic Kyphosis)	Average thoracic kyphosis over time period baseline (0 min) to directly after (1.5 min) the experimental condition		degrees	MEDIAN
PRIMARY	Posture (Lumbar Lordosis)	Average lumbar lordosis over time period baseline (0 min) to directly after (1.5 min) the experimental condition		degrees	MEDIAN
PRIMARY	Posture (Trunk Flexion)	Average trunk flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition		degrees	MEDIAN
PRIMARY	Posture (Hip Flexion)	Average hip flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition		degrees	MEDIAN
PRIMARY	Posture (Knee Flexion)	Average knee flexion over time period baseline (0 min) to directly after (1.5 min) the experimental condition		degrees	MEDIAN
PRIMARY	Knee Compression Force	Average knee compression force (KCF) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition	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.	N	MEDIAN
SECONDARY	Muscular Activity of Rectus Abdominis, Vastus Lateralis, Gastrocnemius Medialis and Trapezius Descendens Muscles.	Average RMS-value (%RVE) over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition.		%RVE	MEDIAN
SECONDARY	Rating of Perceived Discomfort (RPD)	Change from baseline (0 min) to directly after (1.5 min) both experimental conditions		units on a scale	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group55

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Muscular Activity of Erector Spinae Muscle.	With Exoskeleton, Then Without Exoskeleton	RMS-value during first intervention period	11.2	Inter-Quartile Range 8.6 to 16.0	%MVE
Muscular Activity of Erector Spinae Muscle.	Without Exoskeleton, Then With Exoskeleton	RMS-value during first intervention period	11.1	Inter-Quartile Range 8.6 to 14.8	%MVE
Muscular Activity of Erector Spinae Muscle.	With Exoskeleton, Then Without Exoskeleton	RMS-value during second intervention period	12.3	Inter-Quartile Range 9.0 to 17.6	%MVE
Muscular Activity of Erector Spinae Muscle.	Without Exoskeleton, Then With Exoskeleton	RMS-value during second intervention period	10.4	Inter-Quartile Range 7.5 to 13.1	%MVE
Muscular Activity of Biceps Femoris Muscle.	With Exoskeleton, Then Without Exoskeleton	RMS during first intervention period	26.6	Inter-Quartile Range 16.3 to 39.3	%RVE
Muscular Activity of Biceps Femoris Muscle.	Without Exoskeleton, Then With Exoskeleton	RMS during first intervention period	38.7	Inter-Quartile Range 23.9 to 57.5	%RVE
Muscular Activity of Biceps Femoris Muscle.	With Exoskeleton, Then Without Exoskeleton	RMS during second intervention period	35.8	Inter-Quartile Range 24.4 to 45.8	%RVE
Muscular Activity of Biceps Femoris Muscle.	Without Exoskeleton, Then With Exoskeleton	RMS during second intervention period	31.3	Inter-Quartile Range 20.2 to 55.7	%RVE
Posture (Thoracic Kyphosis)	With Exoskeleton, Then Without Exoskeleton	Average angle during first intervention period	12.0	Inter-Quartile Range 7.5 to 15.8	degrees
Posture (Thoracic Kyphosis)	Without Exoskeleton, Then With Exoskeleton	Average angle during first intervention period	15.4	Inter-Quartile Range 8.0 to 21.0	degrees

1 to 10 of 55Source ClinicalTrials.gov

See all 55 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention	STARTED	First With Exoskeleton Then Without Exoskeleton	20
First Intervention	STARTED	First Without Exoskeleton Then With Exoskelton	19
First Intervention	COMPLETED	First With Exoskeleton Then Without Exoskeleton	19
First Intervention	COMPLETED	First Without Exoskeleton Then With Exoskelton	17
First Intervention	NOT COMPLETED	First With Exoskeleton Then Without Exoskeleton	1
First Intervention	NOT COMPLETED	First Without Exoskeleton Then With Exoskelton	2
Second Intervention	STARTED	First With Exoskeleton Then Without Exoskeleton	19
Second Intervention	STARTED	First Without Exoskeleton Then With Exoskelton	17
Second Intervention	COMPLETED	First With Exoskeleton Then Without Exoskeleton	19
Second Intervention	COMPLETED	First Without Exoskeleton Then With Exoskelton	17

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	With Exoskeleton	36
Total, all-cause mortality	Without Exoskeleton	36
Total, other adverse events	With Exoskeleton	36
Total, other adverse events	Without Exoskeleton	36
Total, serious adverse events	With Exoskeleton	36
Total, serious adverse events	Without Exoskeleton	36

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33861139	RESULT	PubMed
34280658	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
With Exoskeleton vs Without Exoskeleton: deaths from any cause	Trial comparisons
With Exoskeleton vs Without Exoskeleton: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

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