Ankle InjuriesThe CAITNCT06927557
The Applicability of the Cumberland Ankle Instability Tool in Basketball Athletes.
An observational study of Ankle Injuries and Ankle Sprains, run by Hacettepe University.
Trial summary
The aim of our study is to evaluate the applicability, validity, and reliability of the Cumberland Ankle Instability Tool (CAIT) in basketball athletes. Given that a significant proportion of injuries in basketball occur in the ankle, our study holds importance for instability assessments conducted in this population. Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries, Ankle Sprains
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 20 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Basketball athletes with a history of ankle sprain, at least one year of basketball experience, and who participate in basketball training at least once per week.
Who may be able to join
- Age between 16 and 45
- History of ankle sprain
- Participation in basketball training at least once per week
Who cannot join
- Participation in basketball training at least once per week
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Applicability of the Cumberland Ankle Instability Tool in Basketball Athletes: Validity and Reliability Study
The aim of our study is to evaluate the applicability, validity, and reliability of the Cumberland Ankle Instability Tool (CAIT) in basketball athletes. Given that a significant proportion of injuries in basketball occur in the ankle, our study holds importance for instability assessments conducted in this population. If the Cumberland Ankle Instability Tool is found to be applicable in basketball athletes, it may be utilized in future research.
Read the detailed description
The aim of our study is to evaluate the applicability, validity, and reliability of the Cumberland Ankle Instability Tool (CAIT) in basketball athletes. Since most injuries in basketball occur in the ankle, our study is significant for assessing instability in this population. If the Cumberland Ankle Instability Tool is found to be applicable in basketball athletes, it may be utilized in future research.
Hypotheses:
H₀ (Null Hypothesis): The Cumberland Ankle Instability Tool is not applicable, valid, or reliable in basketball athletes.
H₁ (Alternative Hypothesis): The Cumberland Ankle Instability Tool is applicable, valid, and reliable in basketball athletes.
The demographic information of the athletes, including height, age, weight, and years of sports experience, will be recorded. The Cumberland Ankle Instability Tool (CAIT) will be created using Google Forms and distributed to the athletes online.
To assess the reliability of the questionnaire, it will be administered twice to the athletes within a 3 to 7-day interval. The following reliability parameters will be calculated:
Internal consistency, Test-retest reliability, Standard error of measurement (SEM), Minimal detectable change (MDC). For validity assessment, the relationship between the Cumberland Ankle Instability Tool (CAIT) and the Foot and Ankle Ability Measure (FAAM) as well as the Identification of Functional Ankle Instability (IdFAI) will be analyzed.
- Conditions
- Ankle Injuries, Ankle Sprains
- Keywords
- ankle instability, validity study, reliability study
- 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 CAIT, a 9-item scale, was developed by Hiller et al., in 2006 to assess ankle instability. It encompasses aspects such as ankle pain, instability during activities of daily living, foot adaptation during physical movements, and the perception of spatial awareness in the foot (Hiller et al., 2006). The questionnaire is designed to capture the feeling of instability across various activities, including running, walking, jumping, and descending stairs. Scores on the scale range from 0 to 30, with higher scores indicating greater ankle stability and 0 representing the worst possible score indicating severe instability.
Measured: Baseline and after one week
Secondary outcomes (2)
Foot and Ankle Ability Measure (FAAM)
The Foot and Ankle Ability Measure (FAAM) is a self-reported questionnaire designed to assess functional limitations in individuals with foot and ankle disorders. It evaluates a patient's ability to perform daily and sports-related activities.
Structure of FAAM:
FAAM consists of two subscales:
Activities of Daily Living (ADL) Subscale - Includes 21 items assessing functional abilities in everyday activities.
Sports Subscale - Includes 8 items evaluating performance in sports-related movements.
Each item is scored using a 5-point Likert scale, ranging from 4 (No difficulty) to 0 (Unable to do it).
Scoring:
Each subscale score is calculated as a percentage of the total possible score. Higher scores indicate better foot and ankle function, while lower scores suggest greater disability.
Measured: Baseline
The Identification of Functional Ankle Instability (IdFAI)
The Identification of Functional Ankle Instability (IdFAI) is a self-reported questionnaire designed to assess the presence and severity of functional ankle instability (FAI) in individuals with a history of ankle sprains or instability.
Structure of IdFAI:
The questionnaire consists of 10 items that evaluate:
History of ankle sprains Perceived ankle instability Functional limitations during daily and sports activities Each item is scored on a weighted scale, with higher scores indicating a greater degree of functional ankle instability.
Scoring:
The total IdFAI score ranges from 0 to 37. Scores ≥ 11 indicate the presence of functional ankle instability. Higher scores suggest greater severity of instability.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start20 May 2025 (estimated)
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Sakarya Applied Sciences University
- Responsible party
- Principal investigator, Birgül Dıngırdan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927557
- Sponsor's protocol ID
- SUBU 3
- Other IDs
- 13.03.2025- 54/20
- Acronym
- The CAIT
- Status last verified
- Apr 2025
- First submitted
- 18 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Applicability of the Cumberland Ankle Instability Tool in Basketball Athletes: Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT06927557
- Acronym / sponsor ID
- The CAIT / SUBU 3
- Conditions
- Ankle Injuries, Ankle Sprains
- Keywords
- ankle instability, validity study, reliability study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Sakarya Applied Sciences University
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 15 Apr 2025 (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 aim of our study is to evaluate the applicability, validity, and reliability of the Cumberland Ankle Instability Tool (CAIT) in basketball athletes. Given that a significant proportion of injuries in basketball occur in the ankle, our study holds importance for instability assessments conducted in this population. If the Cumberland Ankle Instability Tool is found to be applicable in basketball athletes, it may be utilized in future research.
Detailed description
The aim of our study is to evaluate the applicability, validity, and reliability of the Cumberland Ankle Instability Tool (CAIT) in basketball athletes. Since most injuries in basketball occur in the ankle, our study is significant for assessing instability in this population. If the Cumberland Ankle Instability Tool is found to be applicable in basketball athletes, it may be utilized in future research.
Hypotheses:
H₀ (Null Hypothesis): The Cumberland Ankle Instability Tool is not applicable, valid, or reliable in basketball athletes.
H₁ (Alternative Hypothesis): The Cumberland Ankle Instability Tool is applicable, valid, and reliable in basketball athletes.
The demographic information of the athletes, including height, age, weight, and years of sports experience, will be recorded. The Cumberland Ankle Instability Tool (CAIT) will be created using Google Forms and distributed to the athletes online.
To assess the reliability of the questionnaire, it will be administered twice to the athletes within a 3 to 7-day interval. The following reliability parameters will be calculated:
Internal consistency, Test-retest reliability, Standard error of measurement (SEM), Minimal detectable change (MDC). For validity assessment, the relationship between the Cumberland Ankle Instability Tool (CAIT) and the Foot and Ankle Ability Measure (FAAM) as well as the Identification of Functional Ankle Instability (IdFAI) will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Basketball athletes with a history of ankle sprain, at least one year of basketball experience, and who participate in basketball training at least once per week.
Key inclusion criteria (3 listed)
- Age between 16 and 45
- History of ankle sprain
- Participation in basketball training at least once per week
Key exclusion criteria (1 listed)
- Participation in basketball training at least once per week
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: Baseline and after one week
The CAIT, a 9-item scale, was developed by Hiller et al., in 2006 to assess ankle instability. It encompasses aspects such as ankle pain, instability during activities of daily living, foot adaptation during physical movements, and the perception of spatial awareness in the foot (Hiller et al., 2006). The questionnaire is designed to capture the feeling of instability across various activities, including running, walking, jumping, and descending stairs. Scores on the scale range from 0 to 30, with higher scores indicating greater ankle stability and 0 representing the worst possible score indicating severe instability.
2 secondary outcomes
Foot and Ankle Ability Measure (FAAM)
Time frame: Baseline
The Identification of Functional Ankle Instability (IdFAI)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Injuries and Ankle Sprains, run by Hacettepe University.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birgül Dıngırdan (05444694932, birguldingirdan@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: Baseline and after one week). 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 15 Apr 2025.