Ergonomic Evaluation of Microscopic Ear Surgery With Exoskeleton: A Single Site Non-blinded Study (ExoskeletonEar)
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
연구 개요
상태
상태
정황
정황
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Toral Odedra
- 이메일: toral.odedra@nhs.net
연구 연락처 백업
- 이름: Ananth Vijendren, BM, FRCS (ORL-HNS), PhD
- 전화번호: +441438288019
- 이메일: Ananth.vijendren1@nhs.net
연구 장소
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Hertfordshire
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Stevenage, Hertfordshire, 영국, SG1 4AB
- 모병
- Lister Hospital, East and North Hertfordshire Teaching NHS Trust
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연락하다:
- Ananth Vijendren
- 전화번호: +441438285421
- 이메일: ananth.vijendren1@nhs.net
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: CROSS_SECTIONAL
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
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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. |
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Visual Analogue Scale (VAS) Score for Musculoskeletal Strain
기간: From the start of each operation to the end of the surgical procedure, with assessments every 5 minutes
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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
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Difference in Surface Electromyography (sEMG) Amplitude (% Change From Rest)
기간: From the start of each operation to the end of the surgical procedure.
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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.
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Difference in Maximum Surface Electromyography (sEMG) Amplitude
기간: From the start of each operation to the end of the surgical procedure.
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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.
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Ananth Vijendren, East and North Hertfordshire Teaching NHS Trust
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- RD2025-61
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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