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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05412186
Other study ID # REC-FSD-00277
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 30, 2021
Est. completion date August 12, 2022

Study information

Verified date June 2022
Source Riphah International University
Contact Muhammad Kashif
Phone +92418777210
Email kashif.shaffi@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to check reliability and validity, of translated Urdu version of the Cumberland Ankle Instability Tool develop and test its psychometric properties and responsiveness in Urdu speaking population in Pakistan endure with Ankle sprain and ankle instability complaints.


Description:

The Urdu version of the Cumberland Ankle Instability Tool will be translated and dignified for internal reliability test-retest consistency and cross cultural guidelines of self-reported measures, to evaluate validity (convergent and discrimination)of the sample of 125 participants who experience ankle sprain, participants choose by convenience sampling technique reinforced on already elaborated inclusion/exclusion criteria.Evaluation Form will be filled by a patient twice an day by observer for inter observer assessment , with an interval of 30 minutes to 2 hours between the first and second application. Third assessment will be carried out after 7 days obtained by 1st Observer (re-testing),they completed Cumberland Ankle Instability Tool Urdu version who had ankle sprain in past 3 months and also its correlation checked with lower extremity functional scale, visual analogue scale, and Short Form - 36 short form health survey participant also completed these scales, In general population with ankle sprain and ankle instability in this study we intended to translate the original version of Cumberland Ankle Instability Tool into Urdu cross- culturally adaptation and examine psychometric properties and cut-off score of the Cumberland Ankle Instability Tool Urdu version.


Recruitment information / eligibility

Status Recruiting
Enrollment 125
Est. completion date August 12, 2022
Est. primary completion date August 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants who are 18 years of age and - Participants who were able to understand and complete the self-reported questionnaires (native Urdu speakers, with at least 8 years of education). Exclusion Criteria: - People who have ankle sprain episode and/or lower extremity injury within the last 2 months and/or any neurological or neuromuscular disease. - Participants were also excluded if they did not fill out 2 or more questions of the Urdu Version Of Cumberland Ankle Instability Tool

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Pakistan Ripah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumberland Ankle Instability Tool The Cumberland Ankle Instability Tool is combined of 9 items with multiple options decrease patient obligation and increase reliability, related to different aspects of Cumberland Ankle Instability such as ankle pain, daily sports physical activities may cause Ankle sprain, subjective instability, and the response of the ankle to episodes of generous means.The instrument extent sum scores from 0 (severe instability) to 30 (ankle totally stable). 1st day
Primary Lower Extremity Functional Scale The lower extremity functional scale is a well-known and validated patient-rated outcome measure for measuring lower extremity function 1st day
Primary Visual Analogue Scale A Visual Analogue Scale is a measurement tool that attempts to quantify a feature or attitude that is thought to range throughout a continuum of values but is difficult to measure directly. 1st day
Primary Short Form Health Survey - 36 The Short form health survey is a 36-question multipurpose short-form health assessment. It produces an 8-scale score profile as well as summary metrics. It's a broad measure of health rather than one that focuses on a specific age, condition, or treatment group. It produces an eight-scale profile of scores as well as summary indicators of physical and mental health. 1st day
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