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Ergonomic Evaluation of Microscopic Ear Surgery With Exoskeleton: A Single Site Non-blinded Study (ExoskeletonEar)

2. november 2026 opdateret af: East and North Hertfordshire NHS Trust

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

Studieoversigt

Status

Rekruttering

Betingelser

Muskuloskeletal Smerte

Undersøgelsestype

Observationel

Tilmelding (Anslået)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Toral Odedra
E-mail: toral.odedra@nhs.net

Undersøgelse Kontakt Backup

Navn: Ananth Vijendren, BM, FRCS (ORL-HNS), PhD
Telefonnummer: +441438288019
E-mail: Ananth.vijendren1@nhs.net

Studiesteder

Det Forenede Kongerige
- Hertfordshire
  - Stevenage, Hertfordshire, Det Forenede Kongerige, SG1 4AB
    - Rekruttering
    - Lister Hospital, East and North Hertfordshire Teaching NHS Trust
    - Kontakt:
      
      Ananth Vijendren
      
      Telefonnummer: +441438285421
      
      E-mail: ananth.vijendren1@nhs.net

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: COHORT
Tidsperspektiver: CROSS_SECTIONAL

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change in Visual Analogue Scale (VAS) Score for Musculoskeletal Strain Tidsramme: 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) Tidsramme: 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 Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

East and North Hertfordshire NHS Trust

Efterforskere

Ledende efterforsker: Ananth Vijendren, East and North Hertfordshire Teaching NHS Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. september 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

28. september 2026

Først indsendt, der opfyldte QC-kriterier

2. november 2026

Først opslået (Faktiske)

5. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)