Occupational ExposureNCT05097612

Evaluation of a Soft Exoskeleton to Support Forward Leaning and Lifting

A study testing LiftSuit Exoskeleton (low support level), LiftSuit Exoskeleton (medium support level) and LiftSuit Exoskeleton (high support level) in people with Occupational Exposure, run by Swiss Federal Institute of Technology at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Occupational Exposure
What is being tested?: LiftSuit Exoskeleton (low support level), LiftSuit Exoskeleton (medium support level) and LiftSuit Exoskeleton (high support level)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteSwitzerland
Study dates: 8 Nov 2021to 31 Jan 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Included will be volunteers of both sexes within working age (18 to 65 years).

Who cannot join

Participants will be excluded if they cannot perform the tasks (squat lifting and forward leaning) due to physical limitations. Furthermore, people who report acute joint or muscle pain or stiffness, or a self-reported history of such problems will be excluded.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

ETH Zurich, Rehabilitation Engeineering Laboratory
Zurich, 8008

Other trials in Switzerland

About this study

Official title: "Evaluation of a Soft Exoskeleton With Parallel Springs and Its Ability to Reduce Physical Load During Lifting and Leaning"

In this study the LiftSuit version 2.0 designed by Auxivo AG will be used. The LiftSuit is a soft wearable device that is designed to support workers perform physically demanding tasks including repetitive lifting and working in forward leaning positions. It is put on like a backpack and attached to the body using fabric bands and cuffs. Besides soft fabric parts the LiftSuit contains elastics elements. The elastic elements can be flexibly exchanged by the experimenter. For this experiment elastic elements of known stiffness will be hooked into the fabric frame.

Read the detailed description

In a first step participants will try on the LiftSuit exoskeleton and adjust it to their body under supervision of the experimenter. When the LiftSuit exoskeleton is adjusted to the participant it is taken off to allow placement of sensors. The sensors used to record heart rate (Polar H9 heart rate monitor, Polar Electro Europe AG, Germany), muscle activity from 8 muscles in the back and hip region (Delsys Trigno, Delsys Europe, United Kingdom) and movement kinematics (OptiTrack motion capture system, NaturalPoint Inc., USA) will be placed by the experimenter (or participant him/herself). To verify that the electromyography sensors, are working and to obtain normalization values, participants will be instructed to conduct maximal voluntary contractions of each muscle that are being recorded. If needed single sensors can be replaced. After this the exoskeleton will be put back on.

Conditions: Occupational Exposure
Being tested: Placebo LiftSuit Exoskeleton, LiftSuit Exoskeleton (low support level), LiftSuit Exoskeleton (medium support level), LiftSuit Exoskeleton (high support level)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo LiftSuit ExoskeletonDevice
The LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). In this condition the EES are removed from the device to create a placebo device.
LiftSuit Exoskeleton (low support level)Device
The LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). EES of different three different levels of stiffness (low, medium, high stiffness) will be used.
LiftSuit Exoskeleton (medium support level)Device
The LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). EES of different three different levels of stiffness (low, medium, high stiffness) will be used.
LiftSuit Exoskeleton (high support level)Device
The LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). EES of different three different levels of stiffness (low, medium, high stiffness) will be used.

Study groups in NCT05097612
Study group	Role	What they receive
Healthy participant	Experimental	This is a repeated measures design. All participants receive both the intervention and the placebo comparator. Receives: Device: Placebo LiftSuit Exoskeleton; Device: LiftSuit Exoskeleton (low support level); Device: LiftSuit Exoskeleton (medium support level); Device: LiftSuit Exoskeleton (high support level)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in muscle activity of hip extensor muscles (placebo comparator - low support experimental intervention)
An elastic band placed external to the body parallel to the spine and over the hip joint is likely to support the muscles that extend the hip and back. Less hip extensor muscle (m. gluteus maximus, hamstrings) activity is expected in LiftSuit conditions compared to the placebo comparator condition.
Measured: 2 hours
Change in muscle activity of back extensor muscles (placebo comparator - low support experimental intervention)
An elastic band placed external to the body paralell to the spine and over the hip joint is likely to support the muscles that extend the hip and back. Less back muscle activity (erector spinae at lumbar and thoracic level) is expected in LiftSuit conditions compared to the placebo comparator condition.
Measured: 2 hours

Secondary outcomes (2)

Change in muscle activity of hip extensor muscles related to stiffness level of the Elastic Energy Storages (low, medium, high stiffness).
A reduction in muscle activity is expected. This reduction is expected to be related to the stiffness level of the EES. With high stiffness, leading to more support, leading to less muscle activity.
Measured: 2 hours
Change in muscle activity of back muscles related to stiffness level of the Elastic Energy Storages (low, medium, high stiffness).
The reduction in muscle activity is expected to be related to the stiffness level of the EES. With high stiffness, leading to more support, leading to less muscle activity.
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 202131 Jan 2022

First posted28 Oct 2021
Study start8 Nov 2021
Primary completion31 Jan 2022
Study completion31 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Occupational ExposureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05097612
Sponsor's protocol ID: ETH EK 2021-N-151
Status last verified: Nov 2023
First submitted: 11 Oct 2021
Last updated: 29 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Device to be ready for the market

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases
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Not yet recruiting
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Body Temperature Changes, Heat Stress

All Occupational Exposure trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Evaluation of a Soft Exoskeleton With Parallel Springs and Its Ability to Reduce Physical Load During Lifting and Leaning"
ClinicalTrials.gov ID: NCT05097612
Acronym / sponsor ID: ETH EK 2021-N-151
Conditions: Occupational Exposure
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Swiss Federal Institute of TechnologyUniversity, hospital or other
Collaborators: Auxivo AG
Study start: 8 Nov 2021 (actual)
Primary completion: 31 Jan 2022 (actual)
Study completion: 31 Jan 2022 (actual)
First posted: 28 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Healthy participant	Experimental	Device: Placebo LiftSuit Exoskeleton, Device: LiftSuit Exoskeleton (low support level), Device: LiftSuit Exoskeleton (medium support level), Device: LiftSuit Exoskeleton (high support level)This is a repeated measures design. All participants receive both the intervention and the placebo comparator.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Included will be volunteers of both sexes within working age (18 to 65 years).

Key exclusion criteria (1 listed)

Participants will be excluded if they cannot perform the tasks (squat lifting and forward leaning) due to physical limitations. Furthermore, people who report acute joint or muscle pain or stiffness, or a self-reported history of such problems will be excluded.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo LiftSuit ExoskeletonThe LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). In this condition the EES are removed from the device to create a placebo device.	Device	Healthy participant
LiftSuit Exoskeleton (low support level)The LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). EES of different three different levels of stiffness (low, medium, high stiffness) will be used.	Device	Healthy participant
LiftSuit Exoskeleton (medium support level)The LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). EES of different three different levels of stiffness (low, medium, high stiffness) will be used.	Device	Healthy participant
LiftSuit Exoskeleton (high support level)The LiftSuit is a soft passive wearable device that is designed to support the hip and back muscles during forward leaning and lifting. It exerts it function through Elastic Energy Storages (EES). EES of different three different levels of stiffness (low, medium, high stiffness) will be used.	Device	Healthy participant

Primary outcome

Change in muscle activity of hip extensor muscles (placebo comparator - low support experimental intervention)
Time frame: 2 hours
An elastic band placed external to the body parallel to the spine and over the hip joint is likely to support the muscles that extend the hip and back. Less hip extensor muscle (m. gluteus maximus, hamstrings) activity is expected in LiftSuit conditions compared to the placebo comparator condition.
Change in muscle activity of back extensor muscles (placebo comparator - low support experimental intervention)
Time frame: 2 hours
An elastic band placed external to the body paralell to the spine and over the hip joint is likely to support the muscles that extend the hip and back. Less back muscle activity (erector spinae at lumbar and thoracic level) is expected in LiftSuit conditions compared to the placebo comparator condition.

2 secondary outcomes

Change in muscle activity of hip extensor muscles related to stiffness level of the Elastic Energy Storages (low, medium, high stiffness).
Time frame: 2 hours
Change in muscle activity of back muscles related to stiffness level of the Elastic Energy Storages (low, medium, high stiffness).
Time frame: 2 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
Individual participant dataSharing planned: No. Device to be ready for the market

Related trials for Occupational Exposure

RecruitingObservational study
Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases
Occupational Accidents, Incubation Period, Infectious Disese
Recruiting
Effect of a Dietary Supplement Versus Placebo on Serum PFAS Levels in Male Firefighters
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Recruiting
Consecutive Occupational Heat Exposure With and Without Overnight Cooling
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Enrolling by invitation
Personalizing Veterans' Lung Cancer Screening and Diagnosis
Lung Cancer Screening, Military Service-related Environmental and Occupational Exposures
Not yet recruiting
Progressive Heat Exposure and Physiological Strain
Body Temperature Changes, Heat Stress

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Olivier Lambercy, PhD principal investigator

Swiss Federal Institute of Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in muscle activity of hip extensor muscles (placebo comparator - low support experimental intervention) (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05097612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.