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
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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Stevenage, 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 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.
설명
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.
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 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
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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.
기간: 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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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
- RD2026-23
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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