Ankle Disorders InjuriesNCT05732636
Urdu Translation And Cross-Cultural Validation of the Foot And Ankle Disability Index
An observational study of Ankle Disorders Injuries, run by Sehat Medical Complex at 1 site in Pakistan.
Trial summary
The goal of this Cross-cultural validation study is to Urdu translate and cross-cultural validation of Foot and Ankle Disability Index for the Patients with Chronic Ankle Instability. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Ankle Disorders Injuries
- What is being tested?
- Validation study
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jan 2023to 25 Jul 2023
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Athletes at Pakistan Sports Board with Chronic Ankle Instability.
Who may be able to join
- A history of ankle sprain with pain and/or limping for more than 1 day,
- Chronic weakness, pain, or instability that they attributed to the initial injury
- Giving way in the last 6 months.
- Able to read Urdu Language
Who cannot join
- Bilateral ankle instability
- History of ankle fracture
- Ankle injury within 3 months of participation
- History of anterior cruciate ligament injury
- History of balance disorder
- Current participation in supervised physical rehabilitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urdu Translation And Cross-Cultural Validation of the Foot And Ankle Disability Index for the Patients With Chronic Ankle Instability
The goal of this Cross-cultural validation study is to Urdu translate and cross-cultural validation of Foot and Ankle Disability Index for the Patients with Chronic Ankle Instability. The main question it aims to answer was:
- To Translate Foot and Ankle Disability Index in Urdu and to find out the Validity and Reliability for Patients with Chronic Ankle Instability.
Data collection procedure would be, FADI Urdu version was introduced and the patients were asked to fill FADI Urdu version. The questionnaire was filled again by the same participants after one week to assess the test retest reliability. Questionnaire was conducted to have the best result. After the ethical approval, participants who meet the inclusion criteria and who were free from exclusion criteria were explained about the objectives of this study. Only those who gave consent were included in the study.
Read the detailed description
The foot and ankle are common sources of pain and disability, with approximately 2 million people in the United States per year affected by foot pain. As many as 25% of sports injuries have been attributed to the foot or ankle, with ankle sprains accounting for up to 45% of all injuries in some sports. The Foot and Ankle Disability Index (FADI) were designed to assess functional limitations related to foot and ankle conditions. Therefore, it is used to assess the patients with chronic ankle instability. The FADI was originally developed in English. It has been translated and validated in Italian languages and showed excellent reliability and responsiveness. To cross culturally validate the FADI in Urdu, the FADI will be translated in Urdu to assess the chronic ankle instability patients to check the instability. Convenience sampling technique will be used in this study. A study will be conducted at Pakistan Sports Board Lahore including 10 athletes for 1st stage and 50 Athelets in 2nd stage. The aim of this study was to translate FADI in Urdu and to find out the validity and reliability of Urdu version of FADI in patients with chronic ankle instability. Reliability and validity of FADI in Urdu version was evaluated by calculating Cronbach's alpha, intra-class correlation co-efficient and Pearson/ spearman rank correlation co-efficient. SPSS 25 was used for data analysis.
- Conditions
- Ankle Disorders Injuries
- Being tested
- Validation study
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation studyOther
The whole protocol is divided into two stages: Urdu Translation and validation. Following steps were involved.
- First version (Forward Translation): Forward translation from the English to Urdu by two bilingual translators (Version 1)
- Second Version: Three experts compared the original FADI with urdu version of FADI.
- Backward translation: Version 2 was translated Back in English by an independent translator.
- Third Version: was finalized after tracking differences in forward and backward translation.
- Final Version: of Urdu FADI was used on Chronic Ankle Instability patients.
Foot and Ankle Disability Index(FADI) Urdu version was introduced and the patients were asked to fill FADI Urdu version. The questionnaire was filled again by the same participants after one week to assess the test retest reliability.
What is being measured
The primary outcome is the main question the study is designed to answer.
Urdu version of Foot and Ankle Disability Index
The Foot and Ankle Disability Index is a 34-item questionnaire divided into two subscales: the Foot and Ankle Disability Index and the Foot and Ankle Disability Index Sport. The FADI has 26 items, and the FADI Sport has 8. The FADI contains 4 pain related items and 22 activity related items. The FADI Sport contains 8 activity related items. It assesses more difficult tasks that are essential to sport. The FADI Sport is unique in that it is a population-specific subscale designed for athletes. It is designed to address this need by detecting deficits in higher functioning subjects.
Measured: at Day 7
Foot and ankle ability measure (FAAM)
The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. It is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.
Measured: at Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start28 Jan 2023
- Primary completion30 Jun 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Disorders InjuriesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehat Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waseem Javaid, Sehat Medical Complex
- Investigators
- Saira Akbar Bodla, MS-SPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732636
- Sponsor's protocol ID
- sairaakbar0444
- Status last verified
- Aug 2023
- First submitted
- 27 Jan 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urdu Translation And Cross-Cultural Validation of the Foot And Ankle Disability Index for the Patients With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT05732636
- Acronym / sponsor ID
- sairaakbar0444
- Conditions
- Ankle Disorders Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sehat Medical ComplexUniversity, hospital or other
- Study start
- 28 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 17 Feb 2023 (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.
The goal of this Cross-cultural validation study is to Urdu translate and cross-cultural validation of Foot and Ankle Disability Index for the Patients with Chronic Ankle Instability. The main question it aims to answer was:
- To Translate Foot and Ankle Disability Index in Urdu and to find out the Validity and Reliability for Patients with Chronic Ankle Instability.
Data collection procedure would be, FADI Urdu version was introduced and the patients were asked to fill FADI Urdu version. The questionnaire was filled again by the same participants after one week to assess the test retest reliability. Questionnaire was conducted to have the best result. After the ethical approval, participants who meet the inclusion criteria and who were free from exclusion criteria were explained about the objectives of this study. Only those who gave consent were included in the study.
Detailed description
The foot and ankle are common sources of pain and disability, with approximately 2 million people in the United States per year affected by foot pain. As many as 25% of sports injuries have been attributed to the foot or ankle, with ankle sprains accounting for up to 45% of all injuries in some sports. The Foot and Ankle Disability Index (FADI) were designed to assess functional limitations related to foot and ankle conditions. Therefore, it is used to assess the patients with chronic ankle instability. The FADI was originally developed in English. It has been translated and validated in Italian languages and showed excellent reliability and responsiveness. To cross culturally validate the FADI in Urdu, the FADI will be translated in Urdu to assess the chronic ankle instability patients to check the instability. Convenience sampling technique will be used in this study. A study will be conducted at Pakistan Sports Board Lahore including 10 athletes for 1st stage and 50 Athelets in 2nd stage. The aim of this study was to translate FADI in Urdu and to find out the validity and reliability of Urdu version of FADI in patients with chronic ankle instability. Reliability and validity of FADI in Urdu version was evaluated by calculating Cronbach's alpha, intra-class correlation co-efficient and Pearson/ spearman rank correlation co-efficient. SPSS 25 was used for data analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Athletes at Pakistan Sports Board with Chronic Ankle Instability.
Key inclusion criteria (4 listed)
- A history of ankle sprain with pain and/or limping for more than 1 day,
- Chronic weakness, pain, or instability that they attributed to the initial injury
- Giving way in the last 6 months.
- Able to read Urdu Language
Key exclusion criteria (6 listed)
- Bilateral ankle instability
- History of ankle fracture
- Ankle injury within 3 months of participation
- History of anterior cruciate ligament injury
- History of balance disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation studyThe whole protocol is divided into two stages: Urdu Translation and validation. Following steps were involved. 1. First version (Forward Translation): Forward translation from the English to Urdu by two bilingual translators (Version 1) 2. Second Version: Three experts compared the original FADI with urdu version of FADI. 3. Backward translation: Version 2 was translated Back in English by an independent translator. 4. Third Version: was finalized after tracking differences in forward and backward translation. 5. Final Version: of Urdu FADI was used on Chronic Ankle Instability patients. Foot and Ankle Disability Index(FADI) Urdu version was introduced and the patients were asked to fill FADI Urdu version. The questionnaire was filled again by the same participants after one week to assess the test retest reliability. | Other | – |
Primary outcome
Urdu version of Foot and Ankle Disability Index
Time frame: at Day 7
The Foot and Ankle Disability Index is a 34-item questionnaire divided into two subscales: the Foot and Ankle Disability Index and the Foot and Ankle Disability Index Sport. The FADI has 26 items, and the FADI Sport has 8. The FADI contains 4 pain related items and 22 activity related items. The FADI Sport contains 8 activity related items. It assesses more difficult tasks that are essential to sport. The FADI Sport is unique in that it is a population-specific subscale designed for athletes. It is designed to address this need by detecting deficits in higher functioning subjects.
Foot and ankle ability measure (FAAM)
Time frame: at Day 7
The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. It is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.
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 15 Aug 2023.
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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.
Saira Akbar Bodla, MS-SPT principal investigator
Riphah International University
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 Ankle Disorders Injuries, run by Sehat Medical Complex 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 6 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 15 Aug 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?
Urdu version of Foot and Ankle Disability Index (time frame: at Day 7). 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?
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 15 Aug 2023.