- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06052657
Urdu Version of Identification of Functional Ankle Instability Questionnaire
Translation and Psychometric Properties of The Urdu Version of Identification of Functional Ankle Instability Questionnaire in Patients With Ankle Sprain
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 55150
- University of Lahore Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Identification of functional ankle instability
Time Frame: 1 week
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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.
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1 week
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Cumberland ankle instability tool
Time Frame: 1 week
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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
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1 week
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Ankle Instability Instrument (AII)
Time Frame: 1 week
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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.
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1 week
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hafiza Sana Ashraf, MSPT MSK, The University of Lahore
- Principal Investigator: Mehrooj Hanif, MSPT MSK, The University of Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-UOL-506-08-2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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