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Ergonomic Evaluation of Microscopic Ear Surgery With Exoskeleton: A Single Site Non-blinded Study (ExoskeletonEar)

2026年11月2日 更新者：East and North Hertfordshire NHS Trust

The goal of this observational study is to learn whether an exoskeleton system can reduce musculoskeletal strain and pain during microscopic ear surgery in ENT surgeons performing tympanomastoid and related microscopic ear procedures. The main questions it aims to answer are:

Does the use of an exoskeleton reduce musculoskeletal strain (measured via surface EMG activity) during surgery? Does the use of an exoskeleton reduce subjective pain scores in the neck, back, and shoulders during surgery?

Researchers will compare surgeries performed with the exoskeleton versus surgeries performed without the exoskeleton to see if it reduces strain, muscle activity, and pain levels.

Participants will:

Perform microscopic ear surgeries with and without the exoskeleton system Wear surface EMG electrodes on the neck, back, and shoulders to record muscle activity Provide subjective pain/strain scores at regular intervals (every 5 minutes) during surgery Follow standard surgical preparation and positioning procedures before data collection begins

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 英国
    • Hertfordshire
      • Stevenage、Hertfordshire、英国、SG1 4AB
        • 招聘中
        • Lister Hospital, East and North Hertfordshire Teaching NHS Trust
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

The study population consists of ENT surgeons who routinely perform microscopic ear surgeries, including tympanomastoid procedures and hearing implant operations. Participants are clinicians working within the ENT department who are willing to undergo surface EMG monitoring and use the exoskeleton support system during live surgical procedures.

Eligible participants must have experience in microscopic ear surgery and no pre-existing musculoskeletal conditions that would limit their ability to perform surgery or safely use the exoskeleton.

描述

Inclusion Criteria:

  • ENT surgeons who perform a range of microscopic ear surgery including tympanomastoid surgery and hearing implants.
  • Willing to participate with surface EMG (sEMG) monitoring and utilise the Ottobock exoskeleton

Exclusion Criteria:

  • Pre-existing musculoskeletal problems that limits procedures under microscope and tympanomastoid surgery
  • Unable to perform surgery using the exoskeleton

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：CROSS_SECTIONAL

队列和干预

团体/队列
With Exoskeleton

With Exoskeleton:

ENT surgeons performing microscopic ear surgery while wearing the exoskeleton support system. During procedures, participants will have surface EMG electrodes placed on the neck, back, and shoulders to measure muscle activity, and will report subjective pain/strain scores at regular intervals.
Without Exoskeleton

Without Exoskeleton:

ENT surgeons performing microscopic ear surgery under standard conditions without the exoskeleton. The same protocol will be followed, including surface EMG monitoring and regular subjective pain/strain assessments, to allow comparison with the intervention group.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Visual Analogue Scale (VAS) Score for Musculoskeletal Strain
大体时间：From the start of each operation to the end of the surgical procedure, with assessments every 5 minutes

Difference in participant-reported musculoskeletal strain during microscopic tympanomastoid surgery performed with and without the exoskeleton. Strain will be assessed using a Visual Analogue Scale (VAS) at 5-minute intervals throughout each operation.
From the start of each operation to the end of the surgical procedure, with assessments every 5 minutes
Difference in Surface Electromyography (sEMG) Amplitude (% Change From Rest)
大体时间：From the start of each operation to the end of the surgical procedure.

Difference in muscle activity, measured using surface electromyography (sEMG), during microscopic tympanomastoid surgery performed with and without the exoskeleton. Results will be expressed as percentage change from resting sEMG amplitude in the neck, shoulder and back muscles.
From the start of each operation to the end of the surgical procedure.
Difference in Maximum Surface Electromyography (sEMG) Amplitude
大体时间：From the start of each operation to the end of the surgical procedure.

Difference in maximum muscle activity, measured using surface electromyography (sEMG), during microscopic tympanomastoid surgery performed with and without the exoskeleton. Maximum sEMG amplitude will be assessed in the neck, shoulder and back muscles
From the start of each operation to the end of the surgical procedure.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

East and North Hertfordshire NHS Trust

调查人员

  • 首席研究员：Ananth Vijendren、East and North Hertfordshire Teaching NHS Trust

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月24日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年9月28日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月5日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • RD2025-61

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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