跳至主要内容
临床试验/NCT06995469
NCT06995469已完成不适用

Efficacy of a Passive Lower Limb Exoskeleton on Plantar Pressure Distribution to Reduce on Plantar Pressure Distribution to Reduce Prolonged Standing Injuries: Prolonged Standing Injuries

Fundación Universidad Católica de Valencia San Vicente Mártir1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use

研究概览

简要总结

This quasi-experimental study evaluates the effectiveness of a passive lower-limb exoskeleton (Chairless Chair® 2.0) in redistributing plantar pressure and reducing injuries caused by prolonged standing in workplace settings. Conducted on 25 participants, the research measured plantar pressure, body sway, and postural stability with and without the exoskeleton using a pressure platform. Additionally, user fatigue and satisfaction were assessed through validated questionnaires (Borg CR10, QUEST 2.0). The results aim to determine the device's preventive potential regarding musculoskeletal and circulatory issues, contributing to improved ergonomic health and work performance.

详细描述

Prolonged standing is a common requirement in various professional sectors (e.g., healthcare, industry), and is associated with increased risks of musculoskeletal and circulatory disorders, especially in the lower limbs. Conditions such as plantar fasciitis, chronic venous insufficiency, and pressure ulcers are prevalent. These affect worker health, comfort, and productivity, and impose economic burdens on employers and healthcare systems.

Objective To evaluate the effectiveness of a passive exoskeleton for the lower limbs (Chairless Chair® 2.0) in redistributing plantar pressure and reducing musculoskeletal injuries associated with prolonged standing. The study also investigates the device's influence on postural stability, perceived fatigue, and user comfort.

Methodology Study design: Quasi-experimental with repeated measures (participants act as their own control).

Participants: 25 adult workers (aged 18-60), with ≥6 months of exposure to prolonged standing at work. Exclusion criteria included pre-existing musculoskeletal or circulatory disorders and use of orthopedic devices.

Device: Chairless Chair® 2.0 by Noonee Germany GmbH-a passive, non-powered exoskeleton enabling users to alternate between standing and semi-sitting positions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18 to 60 years
  • •Currently employed in jobs requiring prolonged standing (≥4 hours/day)
  • •Minimum 6 months of work experience in such standing-intensive roles
  • •Physically capable of performing normal job tasks
  • •Able and willing to provide informed consent

排除标准

  • •Diagnosis of musculoskeletal or circulatory conditions (e.g., plantar fasciitis, varicose veins, chronic venous insufficiency)
  • •Current use of orthopedic or ergonomic devices, such as foot orthoses
  • •Uncontrolled medical conditions that may pose a risk (e.g., uncontrolled hypertension)
  • •Inability to understand or comply with study procedures

结局指标

主要结局

Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use Change in Plantar Pressure Distribution With vs. Without Passive Exoskeleton Use

时间窗: Immediately after task performance in each condition (with and without exoskeleton) - approximately same workday or within 1-2 days

Mean plantar pressure values (in kilopascals, kPa) will be measured in key foot regions (heel, midfoot, forefoot) using the Podoprint S4 platform. Data will be collected under two conditions: while performing tasks with the Chairless Chair® 2.0 and without it. The comparison will assess the exoskeleton's effectiveness in redistributing plantar loads during prolonged standing.

次要结局

  • Change in Postural Stability With vs. Without Passive Exoskeleton(Immediately after task performance in each condition (with and without exoskeleton))
  • Perceived Fatigue After Work Tasks With vs. Without Exoskeleton(Immediately after task completion in each condition - within same workday)
  • User Comfort and Usability of the Passive Exoskeleton(After using the exoskeleton during a full work session - within 1 day)

研究者

发起方
Fundación Universidad Católica de Valencia San Vicente Mártir
申办方类型
Other
责任方
Principal Investigator
主要研究者

Javier Ferrer Torregrosa

HEAD OF PODIATRY DEPARTMENT

Fundación Universidad Católica de Valencia San Vicente Mártir

研究点 (1)

Loading locations...

相似试验

Efficacy of a Passive Lower Limb Exoskeleton in... | 临床试验