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| Name | Class |
|---|---|
| Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail | OTHER |
| Natural Sciences and Engineering Research Council, Canada | OTHER |
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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repeated measures intervention group | Experimental | 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:
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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | For each lifting task session, change between session's baseline(immediately before the first lifting task block) and immediately after each lifting task block |
| 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. | For each lifting task session, change between session's baseline(immediately before the first lifting task block) and immediately after each lifting task block |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edith Martin, Ph.D | Contact | 4187801301 | emartin@topmed.ca | |
| Gabriel Diamond Ouellette, Ph.D | Contact | gdiamondouellette@topmed.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TOPMED | Recruiting | Québec | Quebec | G1S1C1 | Canada |
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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.
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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 |
| 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. |
| For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block |
| 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. | For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block |
| 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. | For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block |
| 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. | For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block |
| 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. | For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block |
| 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. | For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block |
| 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). | For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block |
| 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). | For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block |
| 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). | For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block |