NCT07750028

Brief Summary

Patient-reported outcome measures (PROMs) are essential tools for assessing upper extremity disability from the patient's perspective and are increasingly incorporated into routine clinical practice and research. The Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) is one of the most widely used PROMs in upper limb surgery worldwide. Although the questionnaire has been translated and validated into multiple languages, no officially translated and psychometrically validated Catalan version is currently available. The aim of this study is to translate, cross-culturally adapt and psychometrically validate the Catalan version of the QuickDASH according to internationally accepted recommendations for PROM translation and validation. The project consists of two sequential phases. Phase I comprises forward translation, synthesis, back-translation, expert committee review and cognitive debriefing. Phase II consists of a prospective observational psychometric validation study in Catalan-speaking adults with upper extremity disorders. The resulting instrument is expected to become the official Catalan version of the QuickDASH for use in clinical practice and research.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Dec 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 6, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 2, 2026

Last Update Submit

August 2, 2026

Conditions

Keywords

QuickDASH;Disabilities of the ArmShoulder and HandPatient-Reported Outcome MeasuresOutcome AssessmentPROMCross-cultural AdaptationTranslationValidation StudyQuestionnaireCatalanPsychometric ValidationUpper Extremity

Outcome Measures

Primary Outcomes (1)

  • Cross-cultural adaptation and psychometric validation of the Catalan QuickDASH

    Successful translation, cross-cultural adaptation and psychometric validation of the Catalan version of the Quick Disabilities of the Arm, Shoulder and Hand questionnaire following internationally accepted recommendations, including cognitive debriefing and expert committee review.

    Baseline and completion of the translation and validation process (approximately 12 months).

Study Arms (1)

Catalan QuickDASH Validation Cohort

Adult Catalan-speaking patients presenting with upper extremity disorders who will complete the Catalan version of the QuickDASH as part of the psychometric validation study. Participants will undergo questionnaire assessment at baseline and a subgroup will complete a second assessment for evaluation of test-retest reliability according to the study protocol.

Eligibility Criteria

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

Adult Catalan-speaking patients (18 years or older) presenting with an upper extremity musculoskeletal disorder (acute or chronic) at the outpatient upper extremity clinic of Parc Taulí Hospital Universitari (Sabadell, Spain), able to read and understand written Catalan and to provide written informed consent

You may qualify if:

  • Age 18 years or older. Native or fluent Catalan speaker. Diagnosis of an upper extremity musculoskeletal disorder requiring assessment using the QuickDASH questionnaire. Able to read and understand written Catalan. Able and willing to provide written informed consent. Able to complete the questionnaire independently.

You may not qualify if:

  • Cognitive impairment preventing questionnaire completion. Severe neurological or psychiatric disorders interfering with questionnaire interpretation. Inability to read or understand Catalan. Refusal or inability to provide written informed consent. Any other condition that, in the opinion of the investigator, could compromise participation or interpretation of questionnaire results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc Taulí Hospital Univesritari

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (3)

  • Mokkink LB, et al. COSMIN Study Design Checklist for Patient-reported Outcome Measurement Instruments. 2019.

    BACKGROUND
  • Institute for Work & Health. Guidelines for the Translation and Cross-Cultural Adaptation of the DASH & QuickDASH Outcome Measures. Toronto: Institute for Work & Health; 2007.

    BACKGROUND
  • Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001 Apr-Jun;14(2):128-46.

    PMID: 11382253BACKGROUND

Study Officials

  • Ana Scott-Tennent De Rivas, MD

    Institut d'Investigació i Innovació Parc Taulí (I3PT)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Scott-Tennent De Rivas, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Orthopaedic Surgery and Traumatology

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 6, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 6, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared. Requests for access to anonymized data may be considered by the Principal Investigator and the sponsor on reasonable request, in accordance with institutional policies, ethical approval and applicable data protection regulations.

Locations