NCT03918876

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

May 11, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

April 13, 2019

Last Update Submit

April 5, 2020

Conditions

Keywords

dancehealthballetmusculoskeletal injurySF-36wellnessdance medicine

Outcome Measures

Primary Outcomes (2)

  • Dance Functional Outcome Score

    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

    The score between the DFOS-IT versus the italian validated version of the SF-36 will be compared

    1 day

Secondary Outcomes (6)

  • DFOS-IT test-retest reliability

    Baseline - Between Day 4 and 30

  • DFOS-IT construct validity

    Mid December 2019

  • DFOS-IT factor analysis and internal consistency

    Mid December 2019

  • DFOS-IT sensitivity

    Mid December 2019

  • DFOS-IT Internal responsiveness

    After 4 months from the first submission

  • +1 more secondary outcomes

Study Arms (2)

Healty Dancers

Healthy adult dancers

Injured Dancers

Injured adult dancers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy and injured adult dancers

You may qualify if:

  • A minimum of 3 years of dance training (classical, contemporary, modern-jazz ..)
  • An Intermediate to expert skill level
  • years of age or older
  • \- No low back or lower extremity injury in the previous 3 months.
  • \- at least one low back or lower extremity injury in the previous 3 months.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unità Operativa di Medicina del Lavoro AOU Sant'Orsola-Malpighi

Bologna, BO, 40138, Italy

Location

Related Publications (8)

  • 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.

  • 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.

  • 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.

  • 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.

  • Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28.

  • Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.

  • 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.

  • 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.

MeSH Terms

Conditions

Wounds and InjuriesMusculoskeletal PainLow Back PainLeg InjuriesMobility Limitation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Officials

  • Paolo Pillastrini, PT, MSc

    University of Bologna

    STUDY CHAIR
  • Giorgio Breda, PT, OMT

    University of Bologna

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 13, 2019

First Posted

April 18, 2019

Study Start

May 11, 2019

Primary Completion

September 30, 2019

Study Completion

October 31, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations