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Exoskeleton DeviceNCT07084974

Evaluation of Trunk Assistance Exoskeleton

A study testing Adjustment and practice session, No trunk assistance and Uplift Lite exoskeleton in people with Exoskeleton Device, run by TOPMED at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Exoskeleton Device
What is being tested?
Adjustment and practice session, No trunk assistance and Uplift Lite exoskeleton
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
4 Jun 2025to 1 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Being able to communicate in french

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Edith Martin, Ph.D contact

4187801301

emartin@topmed.ca

Gabriel Diamond Ouellette, Ph.D contact

gdiamondouellette@topmed.ca

Canada1 site, 1 recruiting
  • TOPMED

    Québec, Quebec, G1S1C1

    Edith Martin, Ph.D, 4187801301, emartin@topmed.ca

    Gabriel Diamond Ouellette, Ph.D, gdiamondouellette@topmed.ca

    Recruiting

Other trials in Canada

About this study

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

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.
Being tested
Adjustment and practice session, No trunk assistance, Uplift Lite exoskeleton, Biolift exoskeleton, Laevo Flex exoskeleton
Keywords
exoskeleton, trunk assistance, cumulative lumbar load, muscular fatigue, lifting task, comfort, acceptability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjustment and practice sessionDevice

    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 assistanceDevice

    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 exoskeletonDevice

    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 exoskeletonDevice

    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 exoskeletonDevice

    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.

Study groups in NCT07084974
Study groupRoleWhat they receive
Repeated measures intervention groupExperimentalParticipants 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.
Receives: Device: Adjustment and practice session; Device: No trunk assistance; Device: Uplift Lite exoskeleton; Device: Biolift exoskeleton; Device: Laevo Flex exoskeleton

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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.

    Measured: 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.

    Measured: 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 (10)
  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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. Magnitude of restriction of movement

    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.

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

  6. Number of cycles with postural instability

    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.

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

  7. Magnitude of postural instability

    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.

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

  8. Exoskeleton pressure points score

    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).

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

  9. Exoskeleton discomfort score

    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).

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

  10. Exoskeleton comfort score

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start4 Jun 2025
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07084974
Sponsor's protocol ID
502_IRSST_Exo
Status last verified
Jul 2025
First submitted
17 Jul 2025
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Adjustment and practice session, No trunk assistance and Uplift Lite exoskeleton in people with Exoskeleton Device, run by TOPMED at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Edith Martin, Ph.D (4187801301, emartin@topmed.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.

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