Evaluation of Trunk Assistance Exoskeleton

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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.
• Устройство 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.
• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Change in spinal compression [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• Being able to communicate in french

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

• TOPMED — Québec

Идентификаторы

NCT: NCT07084974 · 502_IRSST_Exo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗