NCT05097612

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

October 11, 2021

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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).

    2 hours

  • Change in muscle activity of back muscles related to stiffness level of the Elastic Energy Storages (low, medium, high stiffness).

    2 hours

Other Outcomes (2)

  • Change in muscle activity of abdominal muscles (placebo comparator - experimental intervention)

    2 hours

  • Change in hip angle kinematics (placebo comparator - experimental intervention)

    2 hours

Study Arms (1)

Healthy participant

EXPERIMENTAL

This is a repeated measures design. All participants receive both the intervention and the placebo comparator.

Device: Placebo LiftSuit ExoskeletonDevice: LiftSuit Exoskeleton (low support level)Device: LiftSuit Exoskeleton (medium support level)Device: LiftSuit Exoskeleton (high support level)

Interventions

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.

Healthy participant

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.

Healthy participant

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.

Healthy participant

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.

Healthy participant

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETH Zurich, Rehabilitation Engeineering Laboratory

Zurich, 8008, Switzerland

Location

Study Officials

  • Olivier Lambercy, PhD

    Swiss Federal Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 28, 2021

Study Start

November 8, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Device to be ready for the market

Locations