Achilles TendinopathyVISA-ANCT05125198
Translation, Cultural Adaptation and Validation of Urdu Version of VISA-A Questionnaire
An observational study of Achilles Tendinopathy, run by University of Lahore at 1 site in Pakistan.
Trial summary
This study is designed to translate and validate the VISA-A questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendinopathy
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Jun 2021to 30 Dec 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Using the rule of Thumb: Minimum of 3 per items. * Total items in the questionnaire=8 * As per rule of Thumb=8*5=40 * n=40 * *For better accuracy investigators will take sample size of 40 individuals with Achilles tendinopathy and 40 healthy ankles (Conventional group to assess known group validity). * So n=80
Who may be able to join
- Individuals aged over 18 years and both genders.
- Athletic population with the diagnosis of unilateral mid-portion or insertional Achilles tendinopathy, paratendinosis, partial tendon rupture with or without retrocalcaneal bursitis.
- With positive Painful arc sign and Royal London Hospital Test.
- Healthy individuals.
Who cannot join
- Complete rupture of Achilles tendon,
- Pregnant women and those with any history of radicular pain or lower extremity injury
- Previous surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation, Cultural Adaptation, and Validation of Urdu Version of Victorian Institute of Sports Assessment - Achilles (VISA-A) Questionnaire for Athletes With Achilles Tendinopathy
This study is designed to translate and validate the VISA-A questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. The translated version of the gold standard tool will be used by the local population as well as Urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. Hence, to improve quality of life across cultures, there is a need of standard outcome measures in Urdu language.
- Conditions
- Achilles Tendinopathy
- Keywords
- Achilles tendinopathy, Validity, Reliability, Translation, VISA-A
What is being measured
The primary outcome is the main question the study is designed to answer.
Change being assessed in interpretation of Severity of Achilles tendinopathy.among participants using translated version of VISA-A questionnaire.
VISA-A is consisted of eight questions that measured the domains of pain, function in daily living, and sporting activity. Results range from 0 to 100, where 100 represents the perfect score
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 posted18 Nov 2021
- Study start17 Jun 2021
- Primary completion15 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Akram, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125198
- Sponsor's protocol ID
- ULahore
- Acronym
- VISA-A
- Status last verified
- Jan 2022
- First submitted
- 15 Oct 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Cultural Adaptation, and Validation of Urdu Version of Victorian Institute of Sports Assessment - Achilles (VISA-A) Questionnaire for Athletes With Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT05125198
- Acronym / sponsor ID
- VISA-A / ULahore
- Conditions
- Achilles Tendinopathy
- Keywords
- Achilles tendinopathy, Validity, Reliability, Translation, VISA-A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 18 Nov 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.
This study is designed to translate and validate the VISA-A questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. The translated version of the gold standard tool will be used by the local population as well as Urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. Hence, to improve quality of life across cultures, there is a need of standard outcome measures in Urdu language.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Using the rule of Thumb: Minimum of 3 per items. * Total items in the questionnaire=8 * As per rule of Thumb=8*5=40 * n=40 * *For better accuracy investigators will take sample size of 40 individuals with Achilles tendinopathy and 40 healthy ankles (Conventional group to assess known group validity). * So n=80
Key inclusion criteria (4 listed)
- Individuals aged over 18 years and both genders.
- Athletic population with the diagnosis of unilateral mid-portion or insertional Achilles tendinopathy, paratendinosis, partial tendon rupture with or without retrocalcaneal bursitis.
- With positive Painful arc sign and Royal London Hospital Test.
- Healthy individuals.
Key exclusion criteria (3 listed)
- Complete rupture of Achilles tendon,
- Pregnant women and those with any history of radicular pain or lower extremity injury
- Previous surgery
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
Change being assessed in interpretation of Severity of Achilles tendinopathy.among participants using translated version of VISA-A questionnaire.
Time frame: 1 week
VISA-A is consisted of eight questions that measured the domains of pain, function in daily living, and sporting activity. Results range from 0 to 100, where 100 represents the perfect score
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 19 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Achilles Tendinopathy, 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 3 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 19 Jan 2022. 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?
Change being assessed in interpretation of Severity of Achilles tendinopathy.among participants using translated version of VISA-A questionnaire. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2022.