NCT05509465

Brief Summary

A one-arm feasibility study was conducted to test if violinists would accept to play with an identified ergonomic chinrest (EC) with the brand name Kréddle every day for two weeks. Every day the participants had to divide their total playing time equally between EC+ (ergonomic chinrest with shoulder rest) and EC- (ergonomic chinrest without shoulder rest) each day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

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

August 21, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 17, 2022

Last Update Submit

August 19, 2022

Conditions

Keywords

FeasibilityViolin playingergonomic chinrestperformance

Outcome Measures

Primary Outcomes (4)

  • Usability

    Self-reported information about the usability of the EC- and EC+ was obtained by asking questions about perceived performance, comfort, and sound experience, as well as adjustment and confidence level. Furthermore, if the instructions videos given prior to the familiarization period were usable.

    Two weeks

  • Acceptability

    Every day each violinist was encouraged to write feedback in the diary about using EC+, EC- and about the intervention. The descriptions and comments were categorized into comments about using EC-, EC+ or general comments; the response was grouped as positive or negative feedback.

    Two weeks

  • Adherence

    Adherence to the protocol was recorded from the self-administrated two-week diary. The violinist had to answer a small questionnaire and play each day with one of the settings. Adherence is counted as numbers of days played with the different settings out of the two weeks given.

    Two weeks

  • Compliance

    Compliance for playing with EC- and EC+ was reached if the violinist managed to play minimum 25% out of total playing time with each of both settings. If compliance was \<25% it was considered that it would be a problem to use the setting

    Two weeks

Secondary Outcomes (1)

  • Neck movement was recorded by the device called ViMove.

    Two weeks

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+) for a two-week period to test its usability and acceptability. Each day participants have to use half of their playing time with EC+.

Device: Ergonomic chinrest used with a low Super Kun shoulder rest

Ergonomic chinrest used without shoulder rest (EC-)

EXPERIMENTAL

Participants will play the violin using the ergonomic chinrest without a shoulder rest for a two-week period to test its usability and acceptability. Each day participants have to use half of their playing time with EC-.

Device: Ergonomic chinrest

Interventions

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.

Ergonomic chinrest used without shoulder rest (EC-)

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:

  • Writing and speaking Danish or English fluently. Participants had to be trained violinists who could play the protocol classical repertoire and without a permanent employment contract in a Danish symphony orchestra.

You may not qualify if:

  • Trauma on the upper cervical spine or upper extremities within the previous year, previous or planned shoulder/neck operation, life-threatening health disorders, pacemaker or severe eczema on 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 Officials

  • Karen Søgaard, PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
This study is open label, meaning that no masking occurs.
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Model Details: The two intervention groups (EC+ and EC-) consist of the same participants. Every day the same participants have to divide their violin playing time equally between playing with EC+ and EC-. Each day the order of the interventions is decided by the participants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 22, 2022

Study Start

August 21, 2020

Primary Completion

October 16, 2020

Study Completion

October 16, 2020

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations