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
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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Hertfordshire
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Stevenage、Hertfordshire、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 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.
説明
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
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 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. |
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Visual Analogue Scale (VAS) Score for Musculoskeletal Strain
時間枠：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)
時間枠：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
時間枠：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.
|
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
- RD2025-61
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?
医薬品およびデバイス情報、研究文書
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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