Ankle InjuriesNCT04816058
Turkish Version of the Ankle Instability Instrument
An observational study of Ankle Injuries, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to translate the Ankle Instability Instrument into Turkish language, to perform a cultural adaptation study and to evaluate its validity and reliability in the Turkish population. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Determining the level of ankle instability
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2021to 15 Jul 2023
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants with a history of ankle injury and healthy population.
Who may be able to join
- History of ankle injury or sprain at least one time
- Aged between 18 to 40 years
Who cannot join
- Neurological or orthopedic disorders that may affect ankle instability.
- Inclusion criteria for healthy population are; no history of ankle injury or sprain before and. aged between 18 to 40 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validity of the Turkish Version of the Ankle Instability Instrument
This study aimed to translate the Ankle Instability Instrument into Turkish language, to perform a cultural adaptation study and to evaluate its validity and reliability in the Turkish population. Ankle Instability Instrument was developed to determine the ankle instability level of individuals with a history of ankle injury. Assessment of ankle instability is particularly useful in determining the complaints and functional levels of individuals with a history of functional or chronic ankle instability. It is anticipated that introducing this scale to our language will contribute to other studies in this field.
- Conditions
- Ankle Injuries
- Being tested
- Determining the level of ankle instability
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determining the level of ankle instabilityBehavioural
Ankle instability
| Study group | Role | What they receive |
|---|---|---|
| Ankle Instability Group | Patients with a history of ankle instability or injury. Receives: Behavioral: Determining the level of ankle instability | |
| Healthy Group | Participants without a history of ankle injury Receives: Behavioral: Determining the level of ankle instability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Instability Instrument
The Ankle Instability Instrument includes 9 questions that can be answered with yes or no. The first version was developed with 21 questions and later modified into 9 questions. The Ankle Instability Instrument determines the development of functional ankle instability in individuals with an ankle injury. The International Ankle Consortium reported that answering yes to 5 of 9 questions will confirm the presence of functional ankle instability. There are French and Iran versions of the Ankle Instability Instrument.
Measured: 2 weeks
Cumberland Ankle Instability Tool
The ankle instability levels of the participants included in the study will be determined by the Cumberland Ankle Instability Tool. The Cumberland Ankle Instability Tool is a self-assessment scale that determines the presence of functional or chronic ankle instability and the severity of the instability. This scale consists of 9 items and the total score varies between 0 and 30. Lower scores indicate more severe instability.
Measured: 1 day
Secondary outcomes (1)
Short Form 12
Short Form 12 is a valid and reliable scale for determining the level of quality of life. This scale consists of 12 items and can be scored as 8 subscales. These subscales are; physical function, restricted roles due to physical problems, pain, general health, energy / vitality, social functions and mental health with restricted roles due to mental problems. All items are evaluated with a 5-point Likert-type scale, and higher scores indicate better quality of life while lower scores indicate poor quality of life. This scale is used to evaluate the quality of life of healthy individuals with any pathology. Short Form 12 can be scored between 0-100 for each domain.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start25 Mar 2021
- Primary completion1 Jul 2023
- Study completion15 Jul 2023
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 Acibadem 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816058
- Sponsor's protocol ID
- ATADEK-2021-05/09
- Status last verified
- Aug 2023
- First submitted
- 23 Mar 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Ankle Instability Instrument
- ClinicalTrials.gov ID
- NCT04816058
- Acronym / sponsor ID
- ATADEK-2021-05/09
- Conditions
- Ankle Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 25 Mar 2021 (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.
This study aimed to translate the Ankle Instability Instrument into Turkish language, to perform a cultural adaptation study and to evaluate its validity and reliability in the Turkish population. Ankle Instability Instrument was developed to determine the ankle instability level of individuals with a history of ankle injury. Assessment of ankle instability is particularly useful in determining the complaints and functional levels of individuals with a history of functional or chronic ankle instability. It is anticipated that introducing this scale to our language will contribute to other studies in this field.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankle Instability Group | – | Behavioral: Determining the level of ankle instabilityPatients with a history of ankle instability or injury. |
| Healthy Group | – | Behavioral: Determining the level of ankle instabilityParticipants without a history of ankle injury |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants with a history of ankle injury and healthy population.
Key inclusion criteria (2 listed)
- History of ankle injury or sprain at least one time
- Aged between 18 to 40 years
Key exclusion criteria (2 listed)
- Neurological or orthopedic disorders that may affect ankle instability.
- Inclusion criteria for healthy population are; no history of ankle injury or sprain before and. aged between 18 to 40 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determining the level of ankle instabilityAnkle instability | Behavioural | Ankle Instability Group, Healthy Group |
Primary outcome
Ankle Instability Instrument
Time frame: 2 weeks
The Ankle Instability Instrument includes 9 questions that can be answered with yes or no. The first version was developed with 21 questions and later modified into 9 questions. The Ankle Instability Instrument determines the development of functional ankle instability in individuals with an ankle injury. The International Ankle Consortium reported that answering yes to 5 of 9 questions will confirm the presence of functional ankle instability. There are French and Iran versions of the Ankle Instability Instrument.
Cumberland Ankle Instability Tool
Time frame: 1 day
The ankle instability levels of the participants included in the study will be determined by the Cumberland Ankle Instability Tool. The Cumberland Ankle Instability Tool is a self-assessment scale that determines the presence of functional or chronic ankle instability and the severity of the instability. This scale consists of 9 items and the total score varies between 0 and 30. Lower scores indicate more severe instability.
1 secondary outcome
Short Form 12
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Injuries, run by Acibadem University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 14 Aug 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle Instability Instrument (time frame: 2 weeks). The study lists 2 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 14 Aug 2023.