Upper Limb Nerve LesionNCT05088096
Translation, Cultural Adaptation and Psychometric Properties of Urdu Version of Upper Limb Functional Index Questionnaire in Patients With Upper Limb Musculoskeletal Disorders
An observational study of Upper Limb Nerve Lesion and Reliability, run by University of Lahore at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Upper Limb Nerve Lesion, Reliability, Validity
- How many people
- 250 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Mar 2021to 5 Apr 2022
- How long will I take part?
- 2 Days
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects with upper limb musculoskeletal disorders will be enrolled in the study with age limits from 18-40 years. Data will be entered for the first and then after a duration of few days for reliability and validity of questionairre.
Who may be able to join
- 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.
Who cannot join
- Presence of other significant rheumatic disease variants.
- Severe inflammatory arthritis as confirmed by physical examination.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Upper Limb Nerve Lesion, Reliability, Validity
- Keywords
- Translation, Musculoskeletal injury, Upper limb
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross cultural adaptation, translation, reliability and validity of Upper limb functional Index in patients with musculoskeletal disorders
Upper limb musculoskeletal disorder index will be translated into Urdu and will be cross culturally adapt throughout.
Measured: 1 week
Cross cultural adaptation, translation, reliability and validity of Upper limb functional index (ULFI)
It will be assessed for reliability and validity.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start5 Mar 2021
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Limb Nerve LesionStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha Amjad, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088096
- Sponsor's protocol ID
- UOL 0676
- Status last verified
- Jun 2023
- First submitted
- 9 Oct 2021
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Arooj A, Amjad F, Tanveer F, Arslan AU, Ahmad A, Gilani SA. Translation, cross-cultural adaptation and psychometric properties of Urdu version of upper limb functional index; a validity and reliability study. BMC Musculoskelet Disord. 2022 Jul 20;23(1):691. doi: 10.1186/s12891-022-05628-8.
PubMed 35858863
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cultural Adaptation and Psychometric Properties of Urdu Version of Upper Limb Functional Index Questionnaire in Patients With Upper Limb Musculoskeletal Disorders
- ClinicalTrials.gov ID
- NCT05088096
- Acronym / sponsor ID
- UOL 0676
- Conditions
- Upper Limb Nerve Lesion, Reliability, Validity
- Keywords
- Translation, Musculoskeletal injury, Upper limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 21 Oct 2021 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects with upper limb musculoskeletal disorders will be enrolled in the study with age limits from 18-40 years. Data will be entered for the first and then after a duration of few days for reliability and validity of questionairre.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Presence of other significant rheumatic disease variants.
- Severe inflammatory arthritis as confirmed by physical examination.
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
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.
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.
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 9 Jun 2023.
- Derived from this study: PubMed 35858863Arooj A, Amjad F, Tanveer F, Arslan AU, Ahmad A, Gilani SA. Translation, cross-cultural adaptation and psychometric properties of Urdu version of upper limb functional index; a validity and reliability study. BMC Musculoskelet Disord. 2022 Jul 20;23(1):691. doi: 10.1186/s12891-022-05628-8.
- Individual participant dataSharing planned: No
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.
Fareeha Amjad study director
University of Lahore
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 Upper Limb Nerve Lesion and Reliability, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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 9 Jun 2023. 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 Pakistan. 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?
Cross cultural adaptation, translation, reliability and validity of Upper limb functional Index in patients with musculoskeletal disorders (time frame: 1 week). 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 NCT05088096, which also lists 1 linked publication.
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 9 Jun 2023.