Ergonomic Evaluation of Exoskeleton Use in Transoral, Endoscopic, and Transcervical ENT Surgery (ExoskeletonENT)
Ergonomic Evaluation of Exoskeleton Use in Transoral, Endoscopic, and Transcervical ENT Surgery:
The goal of this observational study is to learn whether the use of an exoskeleton system can reduce musculoskeletal strain and fatigue during ENT surgical procedures in ENT surgeons performing transoral, endoscopic, and transcervical operations. The main questions it aims to answer are:
Does the use of an exoskeleton reduce musculoskeletal strain and muscle activity (measured via sEMG and MVC) during surgery? Does the use of an exoskeleton reduce subjective pain and fatigue in the neck, shoulders, and wrists during and after surgery?
Researchers will compare surgeries performed with the exoskeleton to those performed without it to determine if the device reduces physical strain and improves ergonomic outcomes.
Participants will:
Perform ENT surgical procedures with and without the exoskeleton system Have surface EMG electrodes placed on the neck and shoulders to measure muscle activity Undergo maximum voluntary contraction (MVC) testing before and after surgery (including wrist assessments) Provide subjective pain/strain scores at regular intervals (every 10 minutes) during procedures Follow standard surgical preparation and positioning protocols while data are recorded throughout the operation
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Toral Odedra
- Электронная почта: toral.odedra@nhs.net
Учебное резервное копирование контактов
- Имя: Ananth Vijendren, BM, FRCS (ORL-HNS), PhD
- Номер телефона: +441438288019
- Электронная почта: Ananth.vijendren1@nhs.net
Места учебы
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Stevenage, Соединенное Королевство, SG1 4AB
- Рекрутинг
- Lister Hospital, East and North Hertfordshire Teaching NHS Trust
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Контакт:
- Ananth Vijendren
- Номер телефона: +441438285421
- Электронная почта: ananth.vijendren1@nhs.net
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
The study population consists of ENT surgeons who perform transoral, endoscopic, and/or transcervical ENT surgical procedures. Participants are clinicians within the ENT department who are experienced in these surgical techniques and have prior familiarity with the exoskeleton system.
Eligible participants must be willing to undergo surface EMG (sEMG) monitoring and maximum voluntary contraction (MVC) testing, and to use the exoskeleton during live surgical procedures. Surgeons with pre-existing musculoskeletal conditions that limit their ability to perform surgery or safely use the exoskeleton are excluded.
Описание
Inclusion Criteria:
- ENT surgeons who perform a range of transoral, endoscopic and/or transcervical ENT operations.
- Willing to participate with surface EMG (sEMG) monitoring and utilise the Ottobock exoskeleton.
- • Prior familiarisation with the Ottobock exoskeleton, evidenced by completion of at least five (5) documented surgical procedures using the device before enrolment in the study.
Exclusion Criteria:
- Pre-existing musculoskeletal problems that limits transoral, endoscopic and/or transcervical ENT operations
- Inability to safely or effectively perform surgery using the Ottobock exoskeleton.
- Lack of prior familiarisation with the Ottobock exoskeleton, defined as failure to complete at least five (5) documented surgical procedures using the device prior to enrolment in the study.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: CROSS_SECTIONAL
Когорты и вмешательства
Группа / когорта |
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With Exoskeleton
With Exoskeleton: ENT surgeons performing transoral, endoscopic, or transcervical ENT surgical procedures while wearing the exoskeleton support system. Participants will undergo surface EMG (sEMG) monitoring of the neck and shoulder muscles during surgery, along with maximum voluntary contraction (MVC) measurements taken before and after the procedure (including wrist assessments). Subjective pain and fatigue scores will be recorded at regular intervals (every 10 minutes) throughout the operation. |
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Without Exoskeleton
Without Exoskeleton: ENT surgeons performing the same types of surgical procedures under standard conditions without the exoskeleton. The identical protocol will be followed, including sEMG monitoring, pre- and post-operative MVC measurements, and regular subjective pain and fatigue assessments, to allow direct comparison with the intervention group. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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• Differences in VAS and motor unit firing (via sEMG) of participants with and without the exoskeleton during transoral, endoscopic and transcervical ENT surgery. • Change in motor unit firing during MVC comparing before and after the surgical procedure.
Временное ограничение: From the start of each surgery (initiation of sEMG recording) to the end of the surgical procedure, with subjective measurements recorded every 10 minutes throughout the operation.
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From the start of each surgery (initiation of sEMG recording) to the end of the surgical procedure, with subjective measurements recorded every 10 minutes throughout the operation.
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Соавторы и исследователи
Следователи
- Главный следователь: Ananth Vijendren, East and North Hertfordshire Teaching NHS Trust
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- RD2026-23
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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