Clinical trial NCT03918876: Translation and Psychometric Validation of an Italian Version of the Dance Functional Outcome Survey DFOS-IT
Official title: Traduzione, Adattamento Transculturale e Misura Delle proprietà Psicometriche Del Questionario "Dance Functional Outcome Survey" (Dfos) in Lingua Italiana
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injuries
Musculoskeletal Pain
Low Back Pain
Lower Limb Injury
Limitation, Mobility
Health Impairment
Keywords: dance
health
ballet
musculoskeletal injury
SF-36
wellness
dance medicine
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy and injured adult dancers

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dance Functional Outcome Score
timeFrame: 1 day
measure: Validate the Italian translation of the DFOS
timeFrame: 1 day
Secondary outcomes:
measure: DFOS-IT test-retest reliability
timeFrame: Baseline - Between Day 4 and 30
measure: DFOS-IT construct validity
timeFrame: Mid December 2019
measure: DFOS-IT factor analysis and internal consistency
timeFrame: Mid December 2019
measure: DFOS-IT sensitivity
timeFrame: Mid December 2019
measure: DFOS-IT Internal responsiveness
timeFrame: After 4 months from the first submission
measure: DFOS-IT Floor and Ceiling Effects
timeFrame: Mid December 2019
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Unità Operativa di Medicina del Lavoro AOU Sant'Orsola-Malpighi
state: BO
Study officials:
affiliation: University of Bologna
name: Paolo Pillastrini, PT, MSc
role: STUDY_CHAIR
affiliation: University of Bologna
name: Giorgio Breda, PT, OMT
role: STUDY_DIRECTOR
References:
citation: Bronner S, Chodock E, Urbano IER, Smith T. Psychometric Properties of the Dance Functional Outcome Survey (DFOS): Reliability, Validity, and Responsiveness. J Orthop Sports Phys Ther. 2019 Feb;49(2):64-79. doi: 10.2519/jospt.2019.8247. Epub 2018 Jul 27.
citation: Bronner S, Urbano IR. Dance Functional Outcome Survey: Development and Preliminary Analyses. Sports Med Int Open. 2018 Nov 28;2(6):E191-E199. doi: 10.1055/a-0729-3000. eCollection 2018 Nov.
citation: Smith TO, Davies L, de Medici A, Hakim A, Haddad F, Macgregor A. Prevalence and profile of musculoskeletal injuries in ballet dancers: A systematic review and meta-analysis. Phys Ther Sport. 2016 May;19:50-6. doi: 10.1016/j.ptsp.2015.12.007. Epub 2016 Jan 5.
citation: Swain CTV, Bradshaw EJ, Ekegren CL, Whyte DG. The Epidemiology of Low Back Pain and Injury in Dance: A Systematic Review. J Orthop Sports Phys Ther. 2019 Apr;49(4):239-252. doi: 10.2519/jospt.2019.8609. Epub 2019 Jan 18.
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citation: Vassallo AJ, Trevor BL, Mota L, Pappas E, Hiller CE. Injury rates and characteristics in recreational, elite student and professional dancers: A systematic review. J Sports Sci. 2019 May;37(10):1113-1122. doi: 10.1080/02640414.2018.1544538. Epub 2018 Nov 27.
citation: Contri A, Breda G, Vanti C, Pillastrini P, Bronner S. The Dance Functional Outcome Survey: Cultural Adaptation and Psychometric Validation in Italian (DFOS-IT). Med Probl Perform Art. 2021 Sep;36(3):150-162. doi: 10.21091/mppa.2021.3018.