Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03918876
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Angela Contri, University of Bologna

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-I), 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.


Condition or disease
Injuries Musculoskeletal Pain Low Back Pain Lower Limb Injury Limitation, Mobility Health Impairment

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-I 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, 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-I 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-I) 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-I, and the SF-36. If they will take part in the reliability portion, then they filled out the DFOS-I a second time within 4 to 9 days.

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-I 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Traduzione, Adattamento Transculturale e Misura Delle proprietà Psicometriche Del Questionario "Dance Functional Outcome Survey" (Dfos) in Lingua Italiana
Actual Study Start Date : May 11, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 15, 2019

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



Primary Outcome Measures :
  1. 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.

  2. Validate the Italian translation of the DFOS [ Time Frame: 1 day ]
    The score between the DFOS-I versus the italian validated version of the SF-36 will be compared


Secondary Outcome Measures :
  1. DFOS-I test-retest reliability [ Time Frame: Baseline - Between Day 4 and 9 ]
    Assess DFOS-I 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.

  2. DFOS-I construct validity [ Time Frame: Mid December 2019 ]
    Assess DFOS-I 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.

  3. DFOS-I internal consistency [ Time Frame: Mid December 2019 ]
    Assess DFOS-I 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.

  4. DFOS-I sensitivity [ Time Frame: Mid December 2019 ]
    Assess DFOS-I 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.

  5. DFOS-I internal responsiveness [ Time Frame: Mid December 2019 ]
    Assess DFOS-I internal responsiveness in adult dancers with and without musculoskeletal injury to the low back or lower extremities. To determine internal responsiveness, the investigators will examine differences in DFOS and SF-36 scores in injured dancers across 4 time points using repeated-measures (time) analysis of variance. Internal responsiveness will be defined in 4 ways: SEM, minimal detectable change at the 95% CI (MDC95), standardized response mean (SRM), and effect size, using the following equations: MDC95 = 1.96 × √2 × SEM; SRM = mean change in score/SD of change scores; effect size = mean change scores/SD of baseline scores.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy and injured adult dancers
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918876


Contacts
Layout table for location contacts
Contact: Angela Contri, PT, MA +393478824741 angela.contri@libero.it

Locations
Layout table for location information
Italy
Unità Operativa di Medicina del Lavoro AOU Sant'Orsola-Malpighi Recruiting
Bologna, BO, Italy, 40138
Contact: Paolo Pillastrini, Pt, MSc    +390512142496    paolo.pillastrini@unibo.it   
Principal Investigator: Angela Contri, Pt, MA         
Principal Investigator: Giorgio Breda, Pt, OMT         
Principal Investigator: Carla Vanti, Pt, MSc, OMT         
Sub-Investigator: Shaw Bronner, Phd, Pt         
Sub-Investigator: Omar De Bartolomeo, MD, Phd         
Sponsors and Collaborators
Angela Contri
Investigators
Layout table for investigator information
Study Chair: Paolo Pillastrini, PT, MSc University of Bologna
Study Director: Giorgio Breda, PT, OMT University of Bologna

Additional Information:
Publications of Results:

Layout table for additonal information
Responsible Party: Angela Contri, Principal Investigator, University of Bologna
ClinicalTrials.gov Identifier: NCT03918876     History of Changes
Other Study ID Numbers: 71267
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angela Contri, University of Bologna:
dance
health
ballet
musculoskeletal injury
SF-36
wellness
dance medicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Musculoskeletal Pain
Back Pain
Low Back Pain
Mobility Limitation
Leg Injuries
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases