Clinical trial NCT06052657: Urdu Version of Identification of Functional Ankle Instability Questionnaire
Official title: Translation and Psychometric Properties of The Urdu Version of Identification of Functional Ankle Instability Questionnaire in Patients With Ankle Sprain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Sprains
Instability, Joint
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ankle Sprain

Brief 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. 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Identification of functional ankle instability
timeFrame: 1 week
measure: Cumberland ankle instability tool
timeFrame: 1 week
measure: Ankle Instability Instrument (AII)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Mehrooj Hanif, MSPT MSK
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Lahore
name: Hafiza Sana Ashraf, MSPT MSK
role: STUDY_DIRECTOR
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