Ankle SprainsNCT06052657
Urdu Version of Identification of Functional Ankle Instability Questionnaire
An observational study of Ankle Sprains and Instability, Joint, run by University of Lahore at 1 site in Pakistan.
Trial summary
Functional instability should be considered as a potential cause of residual ankle impairment and instability. Even if neuromuscular anomalies are detected, the precise cause of injury and the most efficient prevention strategies remain uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprains, Instability, Joint
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Dec 2022to 25 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ankle Sprain
Who may be able to join
- Individuals who were 18 years of age or older.
- Participants of both genders: male and female.
- Those diagnosed with ankle instability.
- Individuals who had experienced an ankle sprain for a minimum duration of one month.
- Participants who did not receive any medical treatment or physical therapy during the course of the study.
Who cannot join
- Participants who displayed rheumatic or arthritic degenerative changes.
- Those with a history of trauma, such as incidents from road traffic accidents.
- Individuals who had undergone surgery on their lower extremities.
- Participants who had an ongoing history of cancer.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province, 55150
About this study
Official title: Translation and Psychometric Properties of The Urdu Version of Identification of Functional Ankle Instability Questionnaire in Patients With Ankle Sprain
Functional instability should be considered as a potential cause of residual ankle impairment and instability. Even if neuromuscular anomalies are detected, the precise cause of injury and the most efficient prevention strategies remain uncertain. The use of standardized and validated research instruments is strongly advocated. This is due in part to the idea that it allows for international and cross-national comparison of results. Another assumption is that utilizing validated tools increases confidence that they are measuring what they are intended to measure. However, a previously validated tool does not guarantee its applicability in a new period, culture, or setting. The rationale of study is to provide a valid and reliable tool translated into native language of Urdu speaking populations so that self-evaluation of ankle instability can be assessed and re-assessed over the time. The questionnaire is translated into various languages including; French, Japanese, Brazilian, Persian, Thai, Malay, Greek, Chinese, Korean, Turkish and Spanish; whereas, Pakistani Urdu version has not yet studied. The present study fills this literature gap and serves a large proportion of Urdu community around the globe; specially, Pakistan. By measuring the psychometric properties of this scale in Urdu version, quantitatively strengthens up the evidence and patients themselves can report their exact level of disorder by answering a set of questions in their own language.
Read the detailed description
Functional instability should be considered as a potential cause of residual ankle impairment and instability. Even if neuromuscular anomalies are detected, the precise cause of injury and the most efficient prevention strategies remain uncertain. The use of standardized and validated research instruments is strongly advocated. This is due in part to the idea that it allows for international and cross-national comparison of results. Another assumption is that utilizing validated tools increases confidence that they are measuring what they are intended to measure. However, a previously validated tool does not guarantee its applicability in a new period, culture, or setting. The rationale of study is to provide a valid and reliable tool translated into native language of Urdu speaking populations so that self-evaluation of ankle instability can be assessed and re-assessed over the time. The questionnaire is translated into various languages including; French, Japanese, Brazilian, Persian, Thai, Malay, Greek, Chinese, Korean, Turkish and Spanish; whereas, Pakistani Urdu version has not yet studied. The present study fills this literature gap and serves a large proportion of Urdu community around the globe; specially, Pakistan. By measuring the psychometric properties of this scale in Urdu version, quantitatively strengthens up the evidence and patients themselves can report their exact level of disorder by answering a set of questions in their own language.
For this purpose, the research conducted was a Cross-Sectional Validation Study involving 100 patients who had experienced ankle sprains. This study took place at the Department of Physical Therapy within the University of Lahore Teaching Hospital, situated on Defence Road in Lahore, spanning a nine-month duration following synopsis approval. The researchers employed a purposive sampling technique. Inclusion criteria encompassed individuals aged 18 and above, of both genders, diagnosed with ankle instability, and who had suffered from an ankle sprain for at least one month without receiving medical or physical therapy intervention during the study. Exclusions were made for participants displaying rheumatic or arthritic degenerative changes, those with a history of traumatic incidents like road accidents, individuals who had undergone lower extremity surgery, and participants with a current history of cancer. Ethical considerations were met as all participants provided written informed consent, and approval was obtained from the University of Lahore's Ethics Committee. Data collection involved using the translated Urdu version of Identification of Functional Ankle Instability Questionnaire Urdu Version (IDFAI-U).
- Conditions
- Ankle Sprains, Instability, Joint
- Medical subject headings
- Ankle Injuries, Joint Instability
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of functional ankle instability
Functional ankle instability (FAI) is the tendency of the foot to 'give way'. Identification of Functional Ankle Instability questionnaire (IdFAI) is a newly developed questionnaire to detect whether individuals meet the minimum criteria necessary for inclusion in an FAI population. IdFAI consists of 3 factors or domains: First factor focuses on the history of ankle sprain, second factor focuses on the initial ankle sprain, and the third factor focuses on the instability during ADL. Out of total 36 score, a score of 10 or lower indicates that the participant is unlikely to have FAI, whereas a total score of 11 or higher indicates that a participant is likely to have FAI.
Measured: 1 week
Cumberland ankle instability tool
The Cumberland ankle instability tool (CAIT) is a 9-item scale measuring the severity of functional ankle instability. The total score of CAIT ranges from 0 to 30. Items focus on the degree of difficulty in performing different physical activities per ankle. The CAIT has the ability to discriminate between stable and unstable ankles and measures the severity of experienced functional instability, with a cut-off value of 27.5 points
Measured: 1 week
Ankle Instability Instrument (AII)
The Ankle Instability Instrument (AII) was designed specifically to determine ankle instability. It captures the severity of the initial injury, history of ankle instability, and instability during activities of daily living (ADLs). It consists of 12 items related to the individual's perception of ankle instability and its impact on their daily life. Each item is scored on a 0 to 100 scale, with higher scores indicating less perceived instability and better ankle function.
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 posted25 Sep 2023
- Study start21 Dec 2022
- Primary completion10 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehrooj Hanif, MSPT MSK, Principal investigator, University of LahoreHafiza Sana Ashraf, MSPT MSK, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052657
- Sponsor's protocol ID
- REC-UOL-506-08-2023
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 25 Sep 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 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Psychometric Properties of The Urdu Version of Identification of Functional Ankle Instability Questionnaire in Patients With Ankle Sprain
- ClinicalTrials.gov ID
- NCT06052657
- Acronym / sponsor ID
- REC-UOL-506-08-2023
- Conditions
- Ankle Sprains, Instability, Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 25 Sep 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.
Functional instability should be considered as a potential cause of residual ankle impairment and instability. Even if neuromuscular anomalies are detected, the precise cause of injury and the most efficient prevention strategies remain uncertain. The use of standardized and validated research instruments is strongly advocated. This is due in part to the idea that it allows for international and cross-national comparison of results. Another assumption is that utilizing validated tools increases confidence that they are measuring what they are intended to measure. However, a previously validated tool does not guarantee its applicability in a new period, culture, or setting. The rationale of study is to provide a valid and reliable tool translated into native language of Urdu speaking populations so that self-evaluation of ankle instability can be assessed and re-assessed over the time. The questionnaire is translated into various languages including; French, Japanese, Brazilian, Persian, Thai, Malay, Greek, Chinese, Korean, Turkish and Spanish; whereas, Pakistani Urdu version has not yet studied. The present study fills this literature gap and serves a large proportion of Urdu community around the globe; specially, Pakistan. By measuring the psychometric properties of this scale in Urdu version, quantitatively strengthens up the evidence and patients themselves can report their exact level of disorder by answering a set of questions in their own language.
Detailed description
Functional instability should be considered as a potential cause of residual ankle impairment and instability. Even if neuromuscular anomalies are detected, the precise cause of injury and the most efficient prevention strategies remain uncertain. The use of standardized and validated research instruments is strongly advocated. This is due in part to the idea that it allows for international and cross-national comparison of results. Another assumption is that utilizing validated tools increases confidence that they are measuring what they are intended to measure. However, a previously validated tool does not guarantee its applicability in a new period, culture, or setting. The rationale of study is to provide a valid and reliable tool translated into native language of Urdu speaking populations so that self-evaluation of ankle instability can be assessed and re-assessed over the time. The questionnaire is translated into various languages including; French, Japanese, Brazilian, Persian, Thai, Malay, Greek, Chinese, Korean, Turkish and Spanish; whereas, Pakistani Urdu version has not yet studied. The present study fills this literature gap and serves a large proportion of Urdu community around the globe; specially, Pakistan. By measuring the psychometric properties of this scale in Urdu version, quantitatively strengthens up the evidence and patients themselves can report their exact level of disorder by answering a set of questions in their own language.
For this purpose, the research conducted was a Cross-Sectional Validation Study involving 100 patients who had experienced ankle sprains. This study took place at the Department of Physical Therapy within the University of Lahore Teaching Hospital, situated on Defence Road in Lahore, spanning a nine-month duration following synopsis approval. The researchers employed a purposive sampling technique. Inclusion criteria encompassed individuals aged 18 and above, of both genders, diagnosed with ankle instability, and who had suffered from an ankle sprain for at least one month without receiving medical or physical therapy intervention during the study. Exclusions were made for participants displaying rheumatic or arthritic degenerative changes, those with a history of traumatic incidents like road accidents, individuals who had undergone lower extremity surgery, and participants with a current history of cancer. Ethical considerations were met as all participants provided written informed consent, and approval was obtained from the University of Lahore's Ethics Committee. Data collection involved using the translated Urdu version of Identification of Functional Ankle Instability Questionnaire Urdu Version (IDFAI-U).
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ankle Sprain
Key inclusion criteria (5 listed)
- Individuals who were 18 years of age or older.
- Participants of both genders: male and female.
- Those diagnosed with ankle instability.
- Individuals who had experienced an ankle sprain for a minimum duration of one month.
- Participants who did not receive any medical treatment or physical therapy during the course of the study.
Key exclusion criteria (4 listed)
- Participants who displayed rheumatic or arthritic degenerative changes.
- Those with a history of trauma, such as incidents from road traffic accidents.
- Individuals who had undergone surgery on their lower extremities.
- Participants who had an ongoing history of cancer.
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
Identification of functional ankle instability
Time frame: 1 week
Functional ankle instability (FAI) is the tendency of the foot to 'give way'. Identification of Functional Ankle Instability questionnaire (IdFAI) is a newly developed questionnaire to detect whether individuals meet the minimum criteria necessary for inclusion in an FAI population. IdFAI consists of 3 factors or domains: First factor focuses on the history of ankle sprain, second factor focuses on the initial ankle sprain, and the third factor focuses on the instability during ADL. Out of total 36 score, a score of 10 or lower indicates that the participant is unlikely to have FAI, whereas a total score of 11 or higher indicates that a participant is likely to have FAI.
Cumberland ankle instability tool
Time frame: 1 week
The Cumberland ankle instability tool (CAIT) is a 9-item scale measuring the severity of functional ankle instability. The total score of CAIT ranges from 0 to 30. Items focus on the degree of difficulty in performing different physical activities per ankle. The CAIT has the ability to discriminate between stable and unstable ankles and measures the severity of experienced functional instability, with a cut-off value of 27.5 points
Ankle Instability Instrument (AII)
Time frame: 1 week
The Ankle Instability Instrument (AII) was designed specifically to determine ankle instability. It captures the severity of the initial injury, history of ankle instability, and instability during activities of daily living (ADLs). It consists of 12 items related to the individual's perception of ankle instability and its impact on their daily life. Each item is scored on a 0 to 100 scale, with higher scores indicating less perceived instability and better ankle function.
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 25 Sep 2023.
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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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.
Mehrooj Hanif, MSPT MSK principal investigator
University of Lahore
Hafiza Sana Ashraf, MSPT MSK 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 Ankle Sprains and Instability, Joint, 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 5 inclusion and 4 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 25 Sep 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?
Identification of functional ankle instability (time frame: 1 week). The study lists 3 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 25 Sep 2023.