Ankle SprainsNCT05412186
Urdu Version Of Cumberland Ankle Instability Tool: Reliability And Validity Study
An observational study of Ankle Sprains, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprains
- How many people
- 125 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2021to 12 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study subjects of this research will be the general population of having ankle sprain.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ripah International University
Faisalabad, Punjab Province, 38000
Muhammad Kashif, 0418777210, kashif.shaffi@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle Sprains
- Keywords
- Cumberland Ankle Instability Tool, Urdu Version, Reliability, Validity, Ankle Sprains, Ankle Instability
- Medical subject headings
- Ankle Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1st day
Lower Extremity Functional Scale
The lower extremity functional scale is a well-known and validated patient-rated outcome measure for measuring lower extremity function
Measured: 1st day
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.
Measured: 1st day
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.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start30 May 2021
- Primary completion10 Aug 2022 (estimated)
- Study completion12 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412186
- Sponsor's protocol ID
- REC-FSD-00277
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Reliability and Validity of Urdu Version of Cumberland Ankle Instability Tool Among Pakistani Patients Complaining for Ankle Sprain
- ClinicalTrials.gov ID
- NCT05412186
- Acronym / sponsor ID
- REC-FSD-00277
- Conditions
- Ankle Sprains
- Keywords
- Cumberland Ankle Instability Tool, Urdu Version, Reliability, Validity, Ankle Sprains, Ankle Instability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 10 Aug 2022 (estimated)
- Study completion
- 12 Aug 2022 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study subjects of this research will be the general population of having ankle sprain.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Sprains, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Kashif (+92418777210, kashif.shaffi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumberland Ankle Instability Tool (time frame: 1st day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.