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NCT Number: NCT07084974

Evaluation of Trunk Assistance Exoskeleton

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in spinal compression

    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

    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).

  2. Change in muscular exertion perception

    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

    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.

  3. Change in maximal lifting strength

    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

    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.

Secondary outcomes

  1. Exoskeleton assistance score

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

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

  2. Number of cycles with parasitic forces score

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

    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.

  3. Magnitude of parasitic forces score

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

    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.

  4. Number of cycles with restriction of movement

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

    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.

  5. Magnitude of restriction of movement

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

    Participants scored the magnitude of movement restrictions caused by the exoskeleton when these were experienced (min: no movement restriction experienced=0 , max: very high movement restrictions experienced=5) on a 6-level Likert scale.

  6. Number of cycles with postural instability

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

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

  7. Magnitude of postural instability

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

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

  8. Exoskeleton pressure points score

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

    Participants scored the pressure points caused by the exoskeleton when these were experienced on a 5 item 7-level Likert scale(min: no pressure points experienced=0 , max: extreme pressure points experienced=6). The 5 items were different anatomical regions (thighs, hips/lower back, back of thorax, front of thorax, above the shoulders). Combined score is the sum of all items (min: no pressure points experienced=0 , max: extreme pressure points experienced=30).

  9. Exoskeleton discomfort score

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

    Participants scored the discomforts caused by the exoskeleton when these were experienced on a 5 item 5-level Likert scale (min: strongly disagree=-2 , max: strongly agree=+2). The 5 items were different types of discomforts (being hot, sweatiness, itching or iritation of the skin, pinch point, pain). Combined score is the sum of all items (min: no discomforts experienced=-10 , max: extreme discomforts experienced=10).

  10. Exoskeleton comfort score

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

    Participants responded to the statement "I think this exoskeleton is comfortable" on a 5-level Likert scale (min: strongly disagree=-2 , max: strongly agree=+2).

Study contacts

Contact information is provided by the study sponsor or research team.

Edith Martin, Ph.D

CONTACT

[email protected]

4187801301

Gabriel Diamond Ouellette, Ph.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

TOPMED

Other

Collaborators

  • Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
  • Natural Sciences and Engineering Research Council, Canada

Registry information

Official study title

Choosing a Trunk Assistance Exoskeleton: Issues of Cumulative Lumbar Loading, Muscle Fatigue, and Discomfort During Repetitive Lifting Tasks

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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