Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05088096 |
| Other study ID # |
UOL 0676 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 5, 2021 |
| Est. completion date |
April 5, 2022 |
Study information
| Verified date |
June 2023 |
| Source |
University of Lahore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
A reliability and validity study for the cross culturally adapted and translated version of
Upper limb musculoskeletal index questionnaire into Urdu language. This can be used for the
reporting of upper limb musculoskeletal disorders including hand, shoulder and arm
pathologies, carpel tunnel syndrome, osteoarthritis etc.
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.
