Evaluation of Trunk Assistance Exoskeleton

Official title

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

Overview

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.

Interventions

• Device 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
• 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.
• 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.
• 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.
• 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.

Primary outcome measures

• 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]
• 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]
• 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]

Secondary outcome measures (10)

• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Canada · 1 center

• TOPMED — Québec

Identifiers

NCT: NCT07084974 · 502_IRSST_Exo

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗