ErgonomicsNCT05604313
The Effects of Using an Ergonomic Chinrest When Playing the Violin
A study testing Ergonomic chinrest used with low shoulder rest (EC) in people with Ergonomics, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
A one-day crossover randomised trial was conducted to compare violinists using an ergonomic chinrest (EC) with do-as-usual on muscle activation, kinematics and sound. After two weeks of testing the EC, self-perceived evaluations on comfort, performance, sound, neck alignment and muscle tension were reported in a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ergonomics
- What is being tested?
- Ergonomic chinrest used with low shoulder rest (EC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jan 2021to 15 Feb 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- speak and write fluently Danish or English
- Professional violinists
- No severe pain symptoms in the neck or upper extremities (<3) scored on a numeric rating scale from 0 (no pain) to 10 (worst perceived pain).
Who cannot join
- medical conditions that could influence the test result (pacemaker or life-threatening health disorders)
- trauma on the upper cervical spine or upper extremities within the last 12 months
- previous or planned shoulder/neck operation
- severe eczema on the neck and upper extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-reported and Objectively Measured Muscle Tension and Neck Kinematics in Violinists Playing With an Ergonomic and Usual Chinrest: a Randomised Crossover Study
A one-day crossover randomised trial was conducted to compare violinists using an ergonomic chinrest (EC) with do-as-usual on muscle activation, kinematics and sound. After two weeks of testing the EC, self-perceived evaluations on comfort, performance, sound, neck alignment and muscle tension were reported in a questionnaire between EC and do-as-usual.
The main question is to answer if:
- the EC is superior compared to do-as-usual and gives a more aligned neck posture and less muscle tension/dynamic muscle activity
- the EC is subjectively evaluated as better than do-as-usual regarding self-perceived comfort, performance and sound
Read the detailed description
The purpose of this study is to investigate the measurement of neck kinematics, muscle activation and sound when using EC and a usual chinrest and, additionally, their self-reported experience of neck alignment, muscle tension, sound experience, performance, and comfort.
It is a crossover, block randomised (block sizes of 4) and within-subjects experimental design performed in one day. The design was made to compare an ergonomic chinrest used with a low shoulder rest (EC) with preferred chin and shoulder rest (do-as-usual) in a randomised order and the effect on muscle activation, kinematics and sound. The study also includes a two-week familiarisation period testing the EC before the test day (crossover design). After these two weeks, a questionnaire was given to register self-reported performance, comfort and sound experience.
Furthermore, the participants were asked in an SMS about what ergonomic equipment they used after half a year (the EC, do-as-usual or other equipment).
On the test day, all participants played with both setup an excerpt of a music piece (second movement from W. A. Mozart's violin concerto no. 5 in A major),
The required sample size was estimated based on a previous feasibility study of either being in an awkward or neutral position with the head. We aimed to recruit 38 professional violinists. A professional violinist was defined as having finished the music conservatory with the violin as the main subject or attending school enrolled in the last years (master/soloist player).
The protocol was initial feasibility tested, and we report this study using the Consolidated Standards of Reporting Trials (CONSORT) 2010 extension to randomised crossover trials.
- Conditions
- Ergonomics
- Being tested
- Ergonomic chinrest used with low shoulder rest (EC)
- Keywords
- crossover design, neck kinematic, muscle workload, violin playing, performance, comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic chinrest used with low shoulder rest (EC)Device
Participants will play the violin using the ergonomic chinrest with a low Kun Super shoulder rest (EC) for two weeks before the test day (crossover study), measuring upper body kinematic and muscle activity. The novel ergonomic chinrest (Kréddle®, Wyoming, US) is fully adjustable to accommodate each violinist's body type and performance style: regarding height, rotation and tilting. The low Super Kun shoulder rest has been adjusted to be in the lowest position for all legs attached to the violin before the violinists received it. All participants was told not to adjust the shoulder rest but adjust the chinrest.
| Study group | Role | What they receive |
|---|---|---|
| Ergonomic chinrest used with low shoulder rest (EC) | Experimental | Participants will play the violin using the ergonomic chinrest with a low Kun Super shoulder rest (EC) Receives: Device: Ergonomic chinrest used with low shoulder rest (EC) |
| Do-as-usual | No intervention | On the test day (crossover study), participants will play with the usual preferred chin and shoulder rest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper body kinematic was recorded by the device called Vicon
Neck movement data were collected with Vicon measured in degrees of movement in three anatomical planes: 1) head flexion, 2) head lateral bend, 3) head rotation, 4) trunk flexion, 5) trunk rotation and 6) arm abduction. This measurement was recorded on the test day for both setups while playing a music piece. Furthermore, a test was made on the ROM (head) in a sitting position for all participants before measuring the kinematics during the music piece.
Measured: One day
Electromyography was recored with Myon
Wireless sEMG (Myon 320, AG, Switzerland) was used and placed to measure muscle activity bilaterally from the upper trapezius muscles (UT), upper neck extensor muscles (NE), sternocleidomastoideus muscles (SCM) and on the right medial and left anterior deltoideus muscle (DT). This measurement was recorded on the test day for both setups.
Measured: One day
Sound was recorded with Olympus LS-10 stereo digital recorder
Sound measurement was recorded on the test day for both setups
Measured: One day
Self-reported performance score
Three questions were used for an overall performance score: Have you had difficulty with (within the last 14 days) 1) playing your violin? 2) using your normal technique when playing? 3) playing as well as you would like to? The questions were answered on a 5-point Likert scale from no to impossible. These questions were given after the two-week familiarisation period.
Measured: Two weeks
Self-reported comfort score
Five questions are used for the overall comfort score: How comfortable was (the last 14 days) 1) playing with EC-/ EC+, 2) the height of EC (with your chosen adjustment), 3) the configuration of EC that you have chosen, and 4) the size of the EC chinplate? , 5) the chinrest surface against your skin? The question was answered on a 5-point Likert scale from very comfortable to very uncomfortable. These questions were given after the two-week familiarisation period.
Measured: Two weeks
sound quiz
A quiz with six audio files in a randomised order was sent a month after the test day.
The quiz was simple: "Do you play using Kréddle (the EC)": yes, no, don't know.
Measured: one month
Diary
Each day during the two-week familiarisation period the violinists had to fill in a diary: written user feedback that will be categorised into positive, negative or neutral feedback. Furthermore about the EC adjustment and their confidence level.
The adjustment was recorded if they found an adjustment that worked ('Yes', 'No', 'Not yet').
The confidence level when playing with EC was reported on a 5-point Likert scale (5= very confident, 1=not very confident). 'Very confident' was defined as if the violinist could play the music sheets sent to them also after a break of several days
Measured: Two weeks
Secondary outcomes (5)
Adherence
Adherence to the protocol was recorded from the self-administrated two-week diary.
Adherence was counted as the number of days playing with the EC out of the two weeks.
Measured: Two weeks
Compliance
Compliance to the protocol was recorded from the self-administrated two-week diary. Compliance for playing with EC was hours played out of total playing time.
Measured: Two weeks
Follow-up on which product they are using
After the crossover test day the study ends, but the participants have to answer after a half a year if the are still using EC, do-as-usual or another new setup and if it because they participated in this project. This was answered by a SMS message.
Measured: 6 month
Antroprometrics
Body measurements were taken on the test day: neck length, arm length, height and shoulder width
Measured: One day
Instrument measurement
On the test day the measurement of the length of the instrument, the shoulder rest height and chin rest height was taken for both setups (EC and do-as-usual)
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start4 Jan 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
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.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We designed a crossover, block randomised (block sizes of 4) and within-subjects experimental design.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Axel Muusfeldts fond, Region of Southern Denmark, Sygekassernes Helsefond
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604313
- Sponsor's protocol ID
- 20202000-87
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-reported and Objectively Measured Muscle Tension and Neck Kinematics in Violinists Playing With an Ergonomic and Usual Chinrest: a Randomised Crossover Study
- ClinicalTrials.gov ID
- NCT05604313
- Acronym / sponsor ID
- 20202000-87
- Conditions
- Ergonomics
- Keywords
- crossover design, neck kinematic, muscle workload, violin playing, performance, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Axel Muusfeldts fond, Region of Southern Denmark, Sygekassernes Helsefond
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 3 Nov 2022 (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.
A one-day crossover randomised trial was conducted to compare violinists using an ergonomic chinrest (EC) with do-as-usual on muscle activation, kinematics and sound. After two weeks of testing the EC, self-perceived evaluations on comfort, performance, sound, neck alignment and muscle tension were reported in a questionnaire between EC and do-as-usual.
The main question is to answer if:
- the EC is superior compared to do-as-usual and gives a more aligned neck posture and less muscle tension/dynamic muscle activity
- the EC is subjectively evaluated as better than do-as-usual regarding self-perceived comfort, performance and sound
Detailed description
The purpose of this study is to investigate the measurement of neck kinematics, muscle activation and sound when using EC and a usual chinrest and, additionally, their self-reported experience of neck alignment, muscle tension, sound experience, performance, and comfort.
It is a crossover, block randomised (block sizes of 4) and within-subjects experimental design performed in one day. The design was made to compare an ergonomic chinrest used with a low shoulder rest (EC) with preferred chin and shoulder rest (do-as-usual) in a randomised order and the effect on muscle activation, kinematics and sound. The study also includes a two-week familiarisation period testing the EC before the test day (crossover design). After these two weeks, a questionnaire was given to register self-reported performance, comfort and sound experience.
Furthermore, the participants were asked in an SMS about what ergonomic equipment they used after half a year (the EC, do-as-usual or other equipment).
On the test day, all participants played with both setup an excerpt of a music piece (second movement from W. A. Mozart's violin concerto no. 5 in A major),
The required sample size was estimated based on a previous feasibility study of either being in an awkward or neutral position with the head. We aimed to recruit 38 professional violinists. A professional violinist was defined as having finished the music conservatory with the violin as the main subject or attending school enrolled in the last years (master/soloist player).
The protocol was initial feasibility tested, and we report this study using the Consolidated Standards of Reporting Trials (CONSORT) 2010 extension to randomised crossover trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We designed a crossover, block randomised (block sizes of 4) and within-subjects experimental design.
| Arm | Type | Receives |
|---|---|---|
| Ergonomic chinrest used with low shoulder rest (EC) | Experimental | Device: Ergonomic chinrest used with low shoulder rest (EC)Participants will play the violin using the ergonomic chinrest with a low Kun Super shoulder rest (EC) |
| Do-as-usual | No intervention | –On the test day (crossover study), participants will play with the usual preferred chin and shoulder rest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- speak and write fluently Danish or English
- Professional violinists
- No severe pain symptoms in the neck or upper extremities (<3) scored on a numeric rating scale from 0 (no pain) to 10 (worst perceived pain).
Key exclusion criteria (4 listed)
- medical conditions that could influence the test result (pacemaker or life-threatening health disorders)
- trauma on the upper cervical spine or upper extremities within the last 12 months
- previous or planned shoulder/neck operation
- severe eczema on the neck and upper extremities.
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 |
|---|---|---|
| Ergonomic chinrest used with low shoulder rest (EC)Participants will play the violin using the ergonomic chinrest with a low Kun Super shoulder rest (EC) for two weeks before the test day (crossover study), measuring upper body kinematic and muscle activity. The novel ergonomic chinrest (Kréddle®, Wyoming, US) is fully adjustable to accommodate each violinist's body type and performance style: regarding height, rotation and tilting. The low Super Kun shoulder rest has been adjusted to be in the lowest position for all legs attached to the violin before the violinists received it. All participants was told not to adjust the shoulder rest but adjust the chinrest. | Device | Ergonomic chinrest used with low shoulder rest (EC) |
Primary outcome
Upper body kinematic was recorded by the device called Vicon
Time frame: One day
Neck movement data were collected with Vicon measured in degrees of movement in three anatomical planes: 1) head flexion, 2) head lateral bend, 3) head rotation, 4) trunk flexion, 5) trunk rotation and 6) arm abduction. This measurement was recorded on the test day for both setups while playing a music piece. Furthermore, a test was made on the ROM (head) in a sitting position for all participants before measuring the kinematics during the music piece.
Electromyography was recored with Myon
Time frame: One day
Wireless sEMG (Myon 320, AG, Switzerland) was used and placed to measure muscle activity bilaterally from the upper trapezius muscles (UT), upper neck extensor muscles (NE), sternocleidomastoideus muscles (SCM) and on the right medial and left anterior deltoideus muscle (DT). This measurement was recorded on the test day for both setups.
Sound was recorded with Olympus LS-10 stereo digital recorder
Time frame: One day
Sound measurement was recorded on the test day for both setups
Self-reported performance score
Time frame: Two weeks
Three questions were used for an overall performance score: Have you had difficulty with (within the last 14 days) 1) playing your violin? 2) using your normal technique when playing? 3) playing as well as you would like to? The questions were answered on a 5-point Likert scale from no to impossible. These questions were given after the two-week familiarisation period.
Self-reported comfort score
Time frame: Two weeks
Five questions are used for the overall comfort score: How comfortable was (the last 14 days) 1) playing with EC-/ EC+, 2) the height of EC (with your chosen adjustment), 3) the configuration of EC that you have chosen, and 4) the size of the EC chinplate? , 5) the chinrest surface against your skin? The question was answered on a 5-point Likert scale from very comfortable to very uncomfortable. These questions were given after the two-week familiarisation period.
sound quiz
Time frame: one month
A quiz with six audio files in a randomised order was sent a month after the test day. The quiz was simple: "Do you play using Kréddle (the EC)": yes, no, don't know.
Diary
Time frame: Two weeks
Each day during the two-week familiarisation period the violinists had to fill in a diary: written user feedback that will be categorised into positive, negative or neutral feedback. Furthermore about the EC adjustment and their confidence level. The adjustment was recorded if they found an adjustment that worked ('Yes', 'No', 'Not yet'). The confidence level when playing with EC was reported on a 5-point Likert scale (5= very confident, 1=not very confident). 'Very confident' was defined as if the violinist could play the music sheets sent to them also after a break of several days
5 secondary outcomes
Adherence
Time frame: Two weeks
Compliance
Time frame: Two weeks
Follow-up on which product they are using
Time frame: 6 month
Antroprometrics
Time frame: One day
Instrument measurement
Time frame: One day
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 14 Nov 2022.
- Individual participant dataSharing planned: No
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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 Ergonomic chinrest used with low shoulder rest (EC) in people with Ergonomics, run by University of Southern Denmark at 1 site in Denmark.
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 4 inclusion and 4 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 14 Nov 2022. 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 Denmark. 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?
Upper body kinematic was recorded by the device called Vicon (time frame: One day). The study lists 7 primary outcomes in all. 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 14 Nov 2022.