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
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Toral Odedra
- Correo electrónico: toral.odedra@nhs.net
Copia de seguridad de contactos de estudio
- Nombre: Ananth Vijendren, BM, FRCS (ORL-HNS), PhD
- Número de teléfono: +441438288019
- Correo electrónico: Ananth.vijendren1@nhs.net
Ubicaciones de estudio
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Stevenage, Reino Unido, SG1 4AB
- Reclutamiento
- Lister Hospital, East and North Hertfordshire Teaching NHS Trust
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Contacto:
- Ananth Vijendren
- Número de teléfono: +441438285421
- Correo electrónico: ananth.vijendren1@nhs.net
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: CROSS_SECTIONAL
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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.
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Ananth Vijendren, East and North Hertfordshire Teaching NHS Trust
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
Otros números de identificación del estudio
- RD2026-23
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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