ErgonomicsNCT06860048
Trial of Arm Sleeve and Forearm Fatigue During Robotic Surgery
A study testing Arm sleeve in people with Ergonomics, run by Prince of Wales Hospital, Sydney at 1 site in Australia.
Trial summary
The study objective was to investigate whether wearing a forearm compression sleeve during robotic surgery reduces muscle fatigue as measured objectively by a grip strength dynamometer. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ergonomics
- What is being tested?
- Arm sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Oct 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Robotic surgeon
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Australia1 site
Department of Surgery, Prince of Wales Hospital
Randwick, New South Wales, 2031
About this study
Official title: Randomized Controlled Trial of Arm Sleeve and Forearm Fatigue During Robotic Surgery
The study objective was to investigate whether wearing a forearm compression sleeve during robotic surgery reduces muscle fatigue as measured objectively by a grip strength dynamometer.
- Conditions
- Ergonomics
- Being tested
- Arm sleeve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm sleeveDevice
Randomised to wear arm sleeve on left or right
| Study group | Role | What they receive |
|---|---|---|
| Arm sleeve | Active comparator | Randomised to wear arm sleeve on left or right Receives: Device: Arm sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle fatigue
Hand grip strength (muscle fatigue)was assessed at the beginning and at the two-hour mark during the robotic console component of the surgical case, using the Camry Electronic Handgrip Dynamometer (CAMRY model: SCACAM-EH101). The non-sleeve-wearing forearm acted as a control. During testing, the surgeon sat upright with the elbows flexed at right angles by the side of the body and hands in neutral positions (halfway between supination and pronation). The handle was pulled with maximum force for three seconds. The hand grip strength (measured in kg force) was recorded ten times for the dominant (right) and non-dominant (left) hands alternately.
Measured: 2 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErgonomicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Sydney
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shing Wong, Prince of Wales Hospital, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860048
- Sponsor's protocol ID
- 2022/ETH02203
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Arm Sleeve and Forearm Fatigue During Robotic Surgery
- ClinicalTrials.gov ID
- NCT06860048
- Acronym / sponsor ID
- 2022/ETH02203
- Conditions
- Ergonomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Prince of Wales Hospital, SydneyOther government
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective was to investigate whether wearing a forearm compression sleeve during robotic surgery reduces muscle fatigue as measured objectively by a grip strength dynamometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm sleeve | Active comparator | Device: Arm sleeveRandomised to wear arm sleeve on left or right |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Robotic surgeon
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm sleeveRandomised to wear arm sleeve on left or right | Device | Arm sleeve |
Primary outcome
Muscle fatigue
Time frame: 2 hours after intervention
Hand grip strength (muscle fatigue)was assessed at the beginning and at the two-hour mark during the robotic console component of the surgical case, using the Camry Electronic Handgrip Dynamometer (CAMRY model: SCACAM-EH101). The non-sleeve-wearing forearm acted as a control. During testing, the surgeon sat upright with the elbows flexed at right angles by the side of the body and hands in neutral positions (halfway between supination and pronation). The handle was pulled with maximum force for three seconds. The hand grip strength (measured in kg force) was recorded ten times for the dominant (right) and non-dominant (left) hands alternately.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Yes. Data will be shared on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm sleeve in people with Ergonomics, run by Prince of Wales Hospital, Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle fatigue (time frame: 2 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.