NCT05604313

Brief 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 questionnaire between EC and do-as-usual. The main question is to answer if:

  1. 1.the EC is superior compared to do-as-usual and gives a more aligned neck posture and less muscle tension/dynamic muscle activity
  2. 2.the EC is subjectively evaluated as better than do-as-usual regarding self-perceived comfort, performance and sound

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

October 27, 2022

Last Update Submit

November 7, 2022

Conditions

Keywords

crossover designneck kinematicmuscle workloadviolin playingperformancecomfort

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    One day

  • Sound was recorded with Olympus LS-10 stereo digital recorder

    Sound measurement was recorded on the test day for both setups

    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.

    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.

    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.

    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

    Two weeks

Secondary Outcomes (5)

  • Adherence

    Two weeks

  • Compliance

    Two weeks

  • Follow-up on which product they are using

    6 month

  • Antroprometrics

    One day

  • Instrument measurement

    One day

Study Arms (2)

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)

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.

Interventions

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.

Ergonomic chinrest used with low shoulder rest (EC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, 5230, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study is open-label, meaning that no masking occurs. The intervention could not be masked (ergonomic equipment testing).
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: We designed a crossover, block randomised (block sizes of 4) and within-subjects experimental design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2022

First Posted

November 3, 2022

Study Start

January 4, 2021

Primary Completion

February 15, 2022

Study Completion

February 15, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations