Evaluation of Trunk Assistance Exoskeleton

NCT ID: NCT07084974

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-04

Study Completion Date

2026-05-01

Brief Summary

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The goal of this interventional study is to evaluate the effect of three different designs of trunk assistance exoskeletons on cumulative lumbar load, trunk extensors' muscular fatigue and comfort in healthy volunteers. The main questions it aims to answer is: will exoskeletons reduce muscle fatigue and cumulative lumbar load. Participants will :

* get each exoskeletons adjusted and then practice the lifting task and measurement sequence in a first session
* perform a lifting task for 4 blocks of 20 minutes on different sessions for each exoskeleton, another session is performed without assistance.

Detailed Description

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Conditions

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Exoskeleton Device

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will begin by the adjustement and practice session. The order of the 4 other interventions(No trunk assistance, and the 3 exoskeletons: Uplift Lite, Biolift and Laevo Flex) will be randomized in between participants to reduce sequence effects.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Repeated measures intervention group

Participants will perform 5 different intervention sessions:

An adjustment and practice session which is always performed first, then participants will performed 4 lifting tasks sessions in randomized order:

* No trunk assistance session
* Uplift Lite exoskeleton session
* Biolift exoskeleton session
* Laevo Flex exoskeleton session

During each lifting task session, participants will perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at hip height. The task rythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. The handles of the box are positioned at 28 cm above the bottom of the box. Total session duration is about 3 hours for all sessions. Participants will have between 4 and 14 days of rest in between each sessions.

Group Type EXPERIMENTAL

Adjustment and practice session

Intervention Type DEVICE

During the adjustment and practice session, participants will perform the lifting task with each exoskeleton after they are properly fitted. They will also perform the measurement sequence as to limit learning effects during lifting task sessions. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

No trunk assistance

Intervention Type DEVICE

This lifting task session is performed without any trunk assistance exoskeleton. Participants perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Uplift Lite exoskeleton

Intervention Type DEVICE

This lifting task session is performed with the Mawashi Uplift Lite trunk assistance exoskeleton. Participants will perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Biolift exoskeleton

Intervention Type DEVICE

This lifting task session is performed with the Biolift trunk assistance exoskeleton. Participants perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Laevo Flex exoskeleton

Intervention Type DEVICE

This lifting task session is performed with the Leavo Flex trunk assistance exoskeleton. Participants perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Interventions

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Adjustment and practice session

During the adjustment and practice session, participants will perform the lifting task with each exoskeleton after they are properly fitted. They will also perform the measurement sequence as to limit learning effects during lifting task sessions. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Intervention Type DEVICE

No trunk assistance

This lifting task session is performed without any trunk assistance exoskeleton. Participants perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Intervention Type DEVICE

Uplift Lite exoskeleton

This lifting task session is performed with the Mawashi Uplift Lite trunk assistance exoskeleton. Participants will perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Intervention Type DEVICE

Biolift exoskeleton

This lifting task session is performed with the Biolift trunk assistance exoskeleton. Participants perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Intervention Type DEVICE

Laevo Flex exoskeleton

This lifting task session is performed with the Leavo Flex trunk assistance exoskeleton. Participants perform 3 blocks of 20 minutes of the lifting task. The lifting task is a box transfer tasks from the ground to a table adjusted at the participant's hip height. The task rhythm is 7 cycles per minute. The box weight is equivalent to 10% of their maximal lifting strength. Total session duration is about 3 hours.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Being able to communicate in french

Exclusion Criteria

* Back pain in the last year
* Back pain for more than a week in the years prior
* Musculoskeletal injury in the last year
* Trunk musculoskeletal system surgery in the last year
* Scoliosis diagnostic
* Systemic illness, degenerative disease or syndrome related to the trunk musculoskeletal or nervous system
* Body mass index over 35 kg/m\^2
* History of neurological damage
* Any contraindication to the practice of physical activity
* Incapacity to perform the lifting task at the specified rythm
* Medication with a negative impact on balance
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail

OTHER

Sponsor Role collaborator

Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

TOPMED

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TOPMED

Québec, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Edith Martin, Ph.D

Role: CONTACT

4187801301

Gabriel Diamond Ouellette, Ph.D

Role: CONTACT

Facility Contacts

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Edith Martin, Ph.D

Role: primary

4187801301

Gabriel Diamond Ouellette, Ph.D

Role: backup

Other Identifiers

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502_IRSST_Exo

Identifier Type: -

Identifier Source: org_study_id

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