InjuriesDFOS-ITNCT03918876
Translation and Psychometric Validation of an Italian Version of the Dance Functional Outcome Survey DFOS-IT
An observational study of Injuries and Musculoskeletal Pain, run by Angela Contri at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injuries, Musculoskeletal Pain, Low Back Pain
- How many people
- 265 participants
- Where
- 1 siteItaly
- Study dates
- 11 May 2019to 31 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy and injured adult dancers
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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unità Operativa di Medicina del Lavoro AOU Sant'Orsola-Malpighi
Bologna, BO, 40138
About this study
Official title: 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.
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Wounds and Injuries, Musculoskeletal Pain, Low Back Pain, Leg Injuries, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healty Dancers | Healthy adult dancers | |
| Injured Dancers | Injured adult dancers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 day
Secondary outcomes (6)
DFOS-IT test-retest reliability
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.
Measured: Baseline - Between Day 4 and 30
DFOS-IT construct validity
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.
Measured: Mid December 2019
DFOS-IT factor analysis and internal consistency
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.
Measured: Mid December 2019
DFOS-IT sensitivity
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.
Measured: Mid December 2019
DFOS-IT Internal responsiveness
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.
Measured: After 4 months from the first submission
DFOS-IT Floor and Ceiling Effects
Assess DFOS-IT Floor and Ceiling Effects in the injured group
Measured: Mid December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start11 May 2019
- Primary completion30 Sep 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angela Contri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Angela Contri, University of Bologna
- Investigators
- Paolo Pillastrini, PT, MSc, Study chair, University of BolognaGiorgio Breda, PT, OMT, Study director, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918876
- Sponsor's protocol ID
- 71267
- Acronym
- DFOS-IT
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2019
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30053790Bronner 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.
PubMed 30539138Smith 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.
PubMed 27080110Swain 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.
PubMed 30658051Sousa 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.
PubMed 20874835Apolone 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.
PubMed 9817120Vassallo 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.
PubMed 30481111Contri 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.
PubMed 34464961
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traduzione, Adattamento Transculturale e Misura Delle proprietà Psicometriche Del Questionario "Dance Functional Outcome Survey" (Dfos) in Lingua Italiana
- ClinicalTrials.gov ID
- NCT03918876
- Acronym / sponsor ID
- DFOS-IT / 71267
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Angela ContriUniversity, hospital or other
- Study start
- 11 May 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healty Dancers | – | –Healthy adult dancers |
| Injured Dancers | – | –Injured adult dancers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy and injured adult dancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
6 secondary outcomes
DFOS-IT test-retest reliability
Time frame: Baseline - Between Day 4 and 30
DFOS-IT construct validity
Time frame: Mid December 2019
DFOS-IT factor analysis and internal consistency
Time frame: Mid December 2019
DFOS-IT sensitivity
Time frame: Mid December 2019
DFOS-IT Internal responsiveness
Time frame: After 4 months from the first submission
DFOS-IT Floor and Ceiling Effects
Time frame: Mid December 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Results publication: PubMed 30053790Bronner 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.
- Results publication: PubMed 30539138Bronner 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.
- Results publication: PubMed 27080110Smith 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.
- Results publication: PubMed 30658051Swain 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.
- Results publication: PubMed 20874835Sousa 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.
- Results publication: PubMed 9817120Apolone 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.
- Results publication: PubMed 30481111Vassallo 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.
- Derived from this study: PubMed 34464961Contri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Pillastrini, PT, MSc study chair
University of Bologna
Giorgio Breda, PT, OMT study director
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injuries and Musculoskeletal Pain, run by Angela Contri at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dance Functional Outcome Score (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03918876, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.