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
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Toral Odedra
- E-mail: toral.odedra@nhs.net
Estude backup de contato
- Nome: Ananth Vijendren, BM, FRCS (ORL-HNS), PhD
- Número de telefone: +441438288019
- E-mail: Ananth.vijendren1@nhs.net
Locais de estudo
-
-
Hertfordshire
-
Stevenage, Hertfordshire, Reino Unido, SG1 4AB
- Recrutamento
- Lister Hospital, East and North Hertfordshire Teaching NHS Trust
-
Contato:
- Ananth Vijendren
- Número de telefone: +441438285421
- E-mail: ananth.vijendren1@nhs.net
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: CROSS_SECTIONAL
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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. |
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Visual Analogue Scale (VAS) Score for Musculoskeletal Strain
Prazo: From the start of each operation to the end of the surgical procedure, with assessments every 5 minutes
|
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
|
|
Difference in Surface Electromyography (sEMG) Amplitude (% Change From Rest)
Prazo: From the start of each operation to the end of the surgical procedure.
|
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.
|
|
Difference in Maximum Surface Electromyography (sEMG) Amplitude
Prazo: From the start of each operation to the end of the surgical procedure.
|
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.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ananth Vijendren, East and North Hertfordshire Teaching NHS Trust
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- RD2025-61
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .