Evaluation of a Soft Exoskeleton to Support Forward Leaning and Lifting

November 28, 2023 updated by: Swiss Federal Institute of Technology

"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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8008
        • ETH Zurich, Rehabilitation Engeineering Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Healthy participant
This is a repeated measures design. All participants receive both the intervention and the placebo comparator.
Device: Placebo LiftSuit Exoskeleton
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.
Device: 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: 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: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 hours
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 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
2 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in muscle activity of abdominal muscles (placebo comparator - experimental intervention)
Time Frame: 2 hours
An elastic band placed external to the body over the hip joint is likely to support the muscles that extend the hip. It could be that this setup might heightened levels of activity in the abdomen.
2 hours
Change in hip angle kinematics (placebo comparator - experimental intervention)
Time Frame: 2 hours
Changed forces around the hip joint might influence movement kinematics of this joint. Changes in position and acceleration of the joint angle will be calculated.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Federal Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Auxivo AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier Lambercy, PhD, Swiss Federal Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ETH EK 2021-N-151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Device to be ready for the market

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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