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

Study Overview

• Status: Recruiting
• Conditions: Muskuloskeletan Pain

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Toral Odedra; Email: toral.odedra@nhs.net
• Study Contact Backup: Name: Ananth Vijendren, BM, FRCS (ORL-HNS), PhD; Phone Number: +441438288019; Email: Ananth.vijendren1@nhs.net

Study Locations

• United Kingdom
  • Hertfordshire
    • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
      • Recruiting
      • Lister Hospital, East and North Hertfordshire Teaching NHS Trust
      • Contact: Ananth Vijendren; Phone Number: +441438285421; Email: ananth.vijendren1@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: CROSS_SECTIONAL

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analogue Scale (VAS) Score for Musculoskeletal Strain	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)	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	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.

Collaborators and Investigators

• Sponsor: East and North Hertfordshire NHS Trust
• Investigators: Principal Investigator: Ananth Vijendren, East and North Hertfordshire Teaching NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 28, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RD2025-61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No