Urdu Version Of Cumberland Ankle Instability Tool: Reliability And Validity Study

June 6, 2022 updated by: Riphah International University

Assessment of Reliability and Validity of Urdu Version of Cumberland Ankle Instability Tool Among Pakistani Patients Complaining for Ankle Sprain

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 38000
        • Recruiting
        • ripah international university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study subjects of this research will be the general population of having ankle sprain.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cumberland Ankle Instability Tool
Time Frame: 1st day
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
Lower Extremity Functional Scale
Time Frame: 1st day
The lower extremity functional scale is a well-known and validated patient-rated outcome measure for measuring lower extremity function
1st day
Visual Analogue Scale
Time Frame: 1st day
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
Short Form Health Survey - 36
Time Frame: 1st day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC-FSD-00277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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