NCT06052657

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

September 18, 2023

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    1 week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ankle Sprain

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 55150, Pakistan

Location

MeSH Terms

Conditions

Ankle InjuriesJoint Instability

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Mehrooj Hanif, MSPT MSK

    University of Lahore

    PRINCIPAL INVESTIGATOR
  • Hafiza Sana Ashraf, MSPT MSK

    University of Lahore

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 25, 2023

Study Start

December 21, 2022

Primary Completion

August 10, 2023

Study Completion

August 25, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations