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
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Toral Odedra
- メール：toral.odedra@nhs.net
研究連絡先のバックアップ
- 名前：Ananth Vijendren, BM, FRCS (ORL-HNS), PhD
- 電話番号：+441438288019
- メール：Ananth.vijendren1@nhs.net
研究場所
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Stevenage、イギリス、SG1 4AB
- 募集
- Lister Hospital, East and North Hertfordshire Teaching NHS Trust
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コンタクト：
- Ananth Vijendren
- 電話番号：+441438285421
- メール：ananth.vijendren1@nhs.net
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：CROSS_SECTIONAL
コホートと介入
グループ/コホート |
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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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.
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Ananth Vijendren、East and North Hertfordshire Teaching NHS Trust
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- RD2026-23
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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