- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05088096
Translation, Cultural Adaptation and Psychometric Properties of Urdu Version of Upper Limb Functional Index Questionnaire in Patients With Upper Limb Musculoskeletal Disorders
Study Overview
Status
Conditions
Detailed Description
Upper limb functional disorders are quite common among Pakistani population due to high demands of work either manual or using technologies, so these disorders are also of great matter of interest. Therefore, for evaluations, diagnosis and for better treatment, a subjective questionnaire is required and hence, ULFI is a commonly used outcome measure for upper limb.
It has been previously translated into many languages i.e. in native languages of respective countries for better understanding.
Upper limb functional index (ULFI) is originally in English language and much of the Pakistani population is Urdu speaking. That is why it is required to translate the ULFI questionnaire in Urdu language.
Translation guidelines from Beaton and colleagues followed. The patients with upper limb musculoskeletal disorders will be recruited.
Data collection procedure started after the approval from institution review board committee with reference no. IRB-UOL-FAHS/882/2021. Data were collected from the patients after taking consent from them. Data collected on their first visit and second reading taken after 1 week, after that treatment will be given.
Data Analysis:
Reliability:
The ULFI-Urdu will be applied two times by a physiotherapist to determine test-retest reliability. On the first day of assessment the physiotherapist will collect demographic data and patients will answer ULFI-Urdu. For intra-rater reliability, ULFI-Urdu will be reapplied 48 hours later. Between two assessments, no treatment will be provided to minimize clinical differences. The first visit of the patient will be comprised of complete assessment along with the completion of outcome measures and upon his/her second visit the patient outcome measures will be completed before giving any treatment.
Validity:
Construct validity will be assessed by determining pearson correlation between ULFI-Urdu and DASH, ULFI-Ur and SF-12 Ur questionnaire.
Statistical Analysis:
The Kaiser-Meyer-Olkin measure of sampling adequacy will be used to assess for factor analysis and the Barlett test of sphericity, to ensure sampling adequacy. Reliability will be assessed with Cronbach alpha, split half test and test-retest method. Floor and ceiling effects will be determined by calculating the rate of participants that obtained the lowest (0) or highest (80) scores and will be considered present if more than 15 % of the participants achieved the highest or lowest score. Validity will be assessed by explanatory factorial analysis of the ULFI scores obtained at the first meeting. Principal components analysis will be performed with varimax rotation if it will be necessary. The number of potential factors will be suggested by scree plot, Eugen value cut-off >1.0, and 10 % variance. Convergent and divergent validity will be assessed with correlation between pain at rest, activity, DASH score, stiffness, physical function, total score and ULFI score.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Ayesha Arooj
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Both male and female patients will be included.
- Sub-acute or chronic conditions of upper limb musculoskeletal disorders.
- Musculoskeletal disorders such as carpal tunnel syndrome (CTS), tendonitis or tenosynovitis, osteoarthritis, cramp of the hand or forearm from prolonged periods of repetitive movement, hand-arm vibration syndrome (HAVS).
- Patients with unilateral disorders will be included.
Exclusion Criteria:
- Presence of other significant rheumatic disease variants.
- Severe inflammatory arthritis as confirmed by physical examination.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cross cultural adaptation, translation, reliability and validity of Upper limb functional Index in patients with musculoskeletal disorders
Time Frame: 1 week
|
Upper limb musculoskeletal disorder index will be translated into Urdu and will be cross culturally adapt throughout.
|
1 week
|
|
Cross cultural adaptation, translation, reliability and validity of Upper limb functional index (ULFI)
Time Frame: 1 week
|
It will be assessed for reliability and validity.
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Fareeha Amjad, University of Lahore
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOL 0676
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Reliability
-
Rijnstate HospitalUtrecht University; Amsterdam University Medical Centers (UMC), Location Academic...Completed
-
University of YalovaCompleted
-
Hacettepe UniversityUnknownExercise | Reliability | Validity
-
Hacettepe UniversityUnknown
-
Karabuk UniversityCompleted
-
University of Sao PauloActive, not recruitingReliability and ValidityBrazil
-
Gazi UniversityNot yet recruitingReliability | Torque | Wrist | Isokinetic
-
Ege UniversityActive, not recruitingAccuracy | Measurement ReliabilityTurkey (Türkiye)
-
Cairo UniversityCompletedReliability and Validity of the Surgimap Software for Measuring Quadriceps Angle in Healthy SubjectsReliability and ValidityEgypt
-
Istanbul Demiroglu Bilim UniversityCompletedTest-Retest Reliability