Evaluation of Trunk Assistance Exoskeleton

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorTOPMED

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Being able to communicate in french

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Adjustment and practice session

    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

    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

    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

    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

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Repeated measures intervention groupExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Change in spinal compression

Stadiometer measurements require an electronic comparator (Mitutoyo; model 543-730B) mounted on a height-adjustable structure that allows alignment with the longitudinal axis of the spine. To measure spinal compression, the participant should position themselves face down against the wall, feet shoulder-width apart (template on the floor), knees fully extended, arms at their sides, and the following points in "light" contact with the wall: forehead, nose, pelvis (or navel), and toes (without shoes, with socks). The assessor will be asked to take the measurements (10 measurements) at the end of expiration, where they will be asked to hold their breath for 2-3 seconds. The baseline for the lifting task sessions is measured before all lifting task blocks. This measurement, expressed in millimeters, reflects only the vertical position of the electronic comparator. Measure = Mean after Block X - Session's baseline mean(before block 1).

Time frame
For each lifting task session, change between session's baseline(immediately before the first lifting task block) and immediately after each lifting task block
2

Change in muscular exertion perception

Participants score their muscular exertion perception in 5 muscle groups (quadriceps, hamstrings, hip extensors, lumbar extensors, thorax extensors) on the Borg CR-10 scale. The baseline for the lifting task sessions is measured before all lifting task blocks. There are 12 levels to this scale(Minimum=0(No exertion) maximum=10(maximal exertion), all integer values, 0.5 is also an option.

Time frame
For each lifting task session, change between session's baseline(immediately before the first lifting task block) and immediately after each lifting task block
3

Change in maximal lifting strength

Maximal lifting strength is assessed by measuring pulling force on a bar at knee level with a strain gauge. The handle is held firmly by both hands. Participants were asked to bend at the hips and knees so as to keep an extended lower back during the trials, similar to a deadlifting position. During each trial, participants were asked to progressively pull harder on the bar without jerking for 5 seconds. The maximal value expressed in newtons during each trial was used. The baseline measurement is the mean of 3 trials with a 2 minute pause in between trials. Only 1 trial was performed after the last lifting block so as to better assess muscular fatigue by limiting time for recovery.

Time frame
For each lifting task session, change between session's baseline(immediately before the first lifting task block) and immediately after the last lifting task block

Secondary outcomes

1

Exoskeleton assistance score

Participants scored the assistance they felt wearing an exoskeleton on a 5-level Likert scale(min: no assistance= 0, max: considerable assistance = 4).

Time frame
For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block
2

Number of cycles with parasitic forces score

Participants scored the estimated proportion of cycles where parasitic forces were experienced (min:0% of cycles=0 , max:100% of cycles=4) on a 5-level Likert scale.

Time frame
For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block
3

Magnitude of parasitic forces score

Participants scored the magnitude of parasitic forces when these were experienced (min: no forces experienced=0 , max: very high forces experienced=5) on a 6-level Likert scale.

Time frame
For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block
4

Number of cycles with restriction of movement

Participants scored the estimated proportion of cycles where the exoskeleton restrained their movement (min:0% of cycles=0 , max:100% of cycles=4) on a 5-level Likert scale.

Time frame
For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TOPMED

Lead sponsor

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

Collaborator

Natural Sciences and Engineering Research Council, Canada

Collaborator