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临床试验/NCT07084974
NCT07084974招募中不适用

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

TOPMED1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年6月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Change in spinal compression

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Being able to communicate in french

排除标准

  • •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

研究组 & 干预措施

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:

  • 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.

干预措施: Adjustment and practice session (Device)

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:

  • 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.

干预措施: No trunk assistance (Device)

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:

  • 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.

干预措施: Uplift Lite exoskeleton (Device)

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:

  • 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.

干预措施: Biolift exoskeleton (Device)

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:

  • 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.

干预措施: Laevo Flex exoskeleton (Device)

结局指标

主要结局

Change in spinal compression

时间窗: 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).

Change in muscular exertion perception

时间窗: 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.

Change in maximal lifting strength

时间窗: 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.

次要结局

  • Exoskeleton comfort score(For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block)
  • Exoskeleton assistance score(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(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(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(For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block)
  • Magnitude of postural instability(For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block)
  • Exoskeleton pressure points score(For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block)
  • Exoskeleton discomfort score(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(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(For each lifting task session where the participant wore a trunk assistance exosqueleton, immediately after the last lifting task block)

研究者

发起方
TOPMED
申办方类型
Other
责任方
Sponsor

研究点 (1)

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