Translation and Psychometric Validation of an Italian Version of the Dance Functional Outcome Survey DFOS-IT (DFOS-IT)

April 5, 2020 updated by: Angela Contri

Traduzione, Adattamento Transculturale e Misura Delle proprietà Psicometriche Del Questionario "Dance Functional Outcome Survey" (Dfos) in Lingua Italiana

Study Design: Evaluation of the psychometric properties of a translated, culturally adapted questionnaire.

Objective: Translating, culturally adapting, and validating the Italian version of the Dance Functional Outcome Survey (DFOS-IT), allowing its use with Italian-speaking dancers to evaluate their musculoskeletal health and wellbeing inside and outside Italy.

Summary of Background Data: Musculoskeletal injuries are a phenomenon of huge prevalence and has been a major focus within peer-reviewed literature since the 1980s.

Growing attention is devoted to standardized outcome measures to improve interventions for injured dancers.

A translated form of the DFOS, the only existing outcome measure that focus on the unique functional requirements of dancers, has never been validated within the Italian dancers population.

Study Overview

Status

Completed

Conditions

Detailed Description

The DFOS is a dance-specific, lower extremity and low back functional outcome measure, the first and only existing at the moment.

The DFOS-IT questionnaire will be developed involving forward-backward translation, a final re-evaluation made by a representative multidisciplinary expert committee and the realization of a prefinal version to establish a proper correspondence with the original English latest version.

A factor analysis and analyses of internal consistency, construct validity, internal responsiveness and sensitivity will be conducted. The reliability will be measured for internal consistency (Cronbach α) and a factor analysis will be applied to analyse the internal structure. The divergent validity will be measured by comparing the data obtained from the compilation of the DFOS-IT with those of the SF-36 to evaluate the psychometric properties and the equivalence of the results adapted to the Italian language and culture.

The validation of the psychometric properties of the instrument will start after it will been administered digitally, via a link to a website built using LimeSurvey, an application based on a MySQL database that allows the realization of online surveys, to a sample population of at least 140 dancers (10 subjects for each item of DFOS-IT) professionals or pre-professionals of age recruited through companies, professional academies, dance high schools and health professionals working with dancers. Through this link, from the time it will be online up to 30 September 2019, the dancers who will give their informed consent to their voluntary participation, will be able to access the online questionnaire.

Upon enrollment, dancers will answer a demographics questionnaire, the DFOS-IT, and the SF-36. If they will take part in the reliability portion, then they filled out the DFOS-IT a second time within 4 to 9 days and, if in the responsiveness testing, a third time after 4-months.

For the statistical analysis standard psychometric techniques will be used, such as reliability assessments, convergent and discriminant validity tests of each item and of the construct in its entirety, empirical validity tests in relation to the clinical status and formal tests to assess their accuracy to ends to test the hypotheses.

The investigators hypothesize to be able to reproduce a tool that reflects the characteristics of the DOFS in the original language and therefore it will prove to have, even in its Italian version, an acceptable psychometric performance as an outcome and screening measure for dancers. The DFOS-IT will show to be a useful tool to monitor both healthy state and functional limitation following lower extremity or low back injury in adult ballet and modern dancers.

Study Type

Observational

Enrollment (Actual)

265

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Unità Operativa di Medicina del Lavoro AOU Sant'Orsola-Malpighi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy and injured adult dancers

Description

For all dancers, inclusion criteria :

  • A minimum of 3 years of dance training (classical, contemporary, modern-jazz ..)
  • An Intermediate to expert skill level
  • 18 years of age or older

For healthy dancers subgroup, inclusion criteria:

- No low back or lower extremity injury in the previous 3 months.

For injured dancers subgroup, inclusion criteria:

- at least one low back or lower extremity injury in the previous 3 months.

For all dancers exclusion criteria:

  • Non-Italian speaking
  • Pregnancy
  • Current active disease processes other from a musculoskeletal injury in the low back or lower extremity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healty Dancers
Healthy adult dancers
Injured Dancers
Injured adult dancers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dance Functional Outcome Score
Time Frame: 1 day
Self-reported functional outcome questionnaire for ballet and modern dance populations, applicable to musculoskeletal injuries of the low back and lower extremities. The 14-question DFOS assesses the dancer's ability in areas of activities of daily living (ADL, 40 points) and dance technique (technique, 50 points). Total score from 0 to 90, subscore Activities of daily living 40, Technique 50. Higher scores represent better outcomes. Total points are normalized to a percentage, with 100% representing full function without limitations.
1 day
Validate the Italian translation of the DFOS
Time Frame: 1 day
The score between the DFOS-IT versus the italian validated version of the SF-36 will be compared
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFOS-IT test-retest reliability
Time Frame: Baseline - Between Day 4 and 30
Assess DFOS-IT test-retest reliabilty in adult dancers with and without musculoskeletal injury to the low back or lower extremities. Test-retest reliability will be assessed with 1 group (including "healthy" and "injured" dancers), 2 measurements (test-retest), with an effect size change of 0.25, power of 0.95, and a significance level of α = .05. Test-retest reliability analysis separately will compare combined, healthy, and injured groups for the DFOS total score and ADL and technique subscores using the intraclass correlation coefficient. The ICC values of 0.49 or less will be considered low, 0.50 to 0.69 moderate, 0.70 to 0.89 high, and 0.90 to 1.00 very high.
Baseline - Between Day 4 and 30
DFOS-IT construct validity
Time Frame: Mid December 2019
Assess DFOS-IT construct validity in with 1 group (adult dancers with and without musculoskeletal injury to the low back or lower extremities), with an effect-size change of 0.25, power of 0.95, and a significance level of α = .05.
Mid December 2019
DFOS-IT factor analysis and internal consistency
Time Frame: Mid December 2019
Assess DFOS-IT factor analysis and internal consistency in adult dancers with and without musculoskeletal injury to the low back or lower extremities. Cronbach's alpha will be calculate to estimate internal item consistency.
Mid December 2019
DFOS-IT sensitivity
Time Frame: Mid December 2019
Assess DFOS-IT sensitivity in adult dancers with and without musculoskeletal injury to the low back or lower extremities. To conduct sensitivity analyses in the healthy group and injured group, the researchers will conduct a t test for equal variances not assumed and a significant Levene test.
Mid December 2019
DFOS-IT Internal responsiveness
Time Frame: After 4 months from the first submission
participants are classified as 'improved' (injured at T0 and healthy at T4mo), 'worsened' (healthy at T0 and injured at T4mo) or 'no change' (health status unchanged from T0 to T4mo). We will examine differences in DFOS-IT and SF-36 scores across 3-time-points using repeated-measures ANOVA. Internal responsiveness was defined using SEM, minimal detectable change at the 95%CI, standardized response mean and effect size and calculated for all DFOS-IT scores, SF-36 PCS and MCS.
After 4 months from the first submission
DFOS-IT Floor and Ceiling Effects
Time Frame: Mid December 2019
Assess DFOS-IT Floor and Ceiling Effects in the injured group
Mid December 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angela Contri

Investigators

  • Study Chair: Paolo Pillastrini, PT, MSc, University of Bologna
  • Study Director: Giorgio Breda, PT, OMT, University of Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 11, 2019

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

October 31, 2019

Study Registration Dates

First Submitted

April 13, 2019

First Submitted That Met QC Criteria

April 16, 2019

First Posted (ACTUAL)

April 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 5, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71267

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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