Ankle SprainsNCT05441319
Effect of Chronic Ankle Instability on Core Stabilization, Dynamic Balance and Agility
An observational study of Ankle Sprains and Ankle Injuries, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
Ankle sprains are the most common injury in basketball, especially involving repetitive maneuvers such as acceleration, deceleration, jumping, and landing. The incidence of ankle sprain is 40% in female basketball players and 75% in male basketball players. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Sprains, Ankle Injuries, Chronic Ankle Instability
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2022to 1 Jan 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: It is planned to include athletes aged 18-25, who play in university basketball teams, with and without chronic ankle instability in our study. It will include students between the ages of 18-25 who study at Yeditepe University and play in Yeditepe University basketball teams.
Who may be able to join
- To be a voluntary participant in the research.
- To be between the ages of 18-25.
- Experiencing recurrent sprains with inflammatory symptoms (pain, swelling) for individuals in the study group whose initial history of sprains was at least 1 year prior to the study.
- Playing in the basketball team for at least 1 season.
- Having a "feeling of insecurity" and instability in the injured ankle as verified by the Cumberland Ankle Instability Tool (CAIT) score of ≤25 for individuals in the research group.
- For the individuals in the research group, not having experienced an ankle sprain in the last 1 month.
Who cannot join
- History of surgery for musculoskeletal structures in both lower extremities
- History of fracture in both lower extremities
- Acute injury of the musculoskeletal structures of other joints of the lower extremity affecting joint function and integrity in the last 3 months
- Presence of bilateral ankle instability
- Balance or vestibular disorder
- Abdominal surgery history
- To have had a musculoskeletal injury of the waist, back and neck in the last 3 months.
- To have experienced an ankle injury in the last 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Chronic Ankle Instability on Core Stabilization, Dynamic Balance and Agility in Basketball Players of an University
Ankle sprains are the most common injury in basketball, especially involving repetitive maneuvers such as acceleration, deceleration, jumping, and landing. The incidence of ankle sprain is 40% in female basketball players and 75% in male basketball players. It is also known that chronic ankle instability (CAI) develops in 20-40% of cases. The effects of chronic ankle instability on core stabilization, dynamic balance and agility in basketball players have been investigated in the literature, and it has been stated that more studies are needed on the subject.
The aim of this study is to examine the effects of chronic ankle instability on core stabilization, dynamic balance and agility in basketball players playing in the university team.
The hypothesis of the study is that there is a difference between core stabilization, dynamic balance and agility values of basketball players playing in the university team with and without chronic ankle instability.
Read the detailed description
Approximately 10% to 28% of all sports injuries are ankle sprains. Ankle sprains are the most common injury in basketball, especially involving repetitive maneuvers such as acceleration, deceleration, jumping, and landing. The incidence of ankle sprain is 40% in female basketball players and 75% in male basketball players. It is also known that chronic ankle instability (CAI) develops in 20-40% of cases. People with CAI have several types of deficits, including decreased ankle range of motion, decreased ankle arthrokinematic quality of movement, problems with postural control and strength, impaired proprioception and neuromuscular control, and altered gait patterns. These problems can cause loss of matches, increase in health expenditures and future injuries in athletes. Postural control disorders that play a role in the regulation of balance have been shown to be common in people with CAI and after acute lateral ankle sprain. Postural control requires somatosensory, visual and vestibular stimuli and appropriate motor response to generate the appropriate balance response. In individuals with CAI, the ankle joint and postural control mechanisms that cannot receive appropriate afferent stimulation and cannot reveal the correct efferent stimulation from the central nervous system are impaired.
Agility, the ability to make rapid changes in the direction of movement, is widely regarded as an important criterion for success in basketball. Agility tests require rapid deceleration, change of direction, and reacceleration during movements. Such activities put athletes in a condition that can force the ankle complex into excessive inversion and plantar flexion, which often causes ankle sprain.
The relationship between chronic ankle instability and athletic performance parameters has been investigated in previous studies. However, the relationship between chronic ankle instability and athletic performance parameters has not yet been fully explained, and it has been stated that more studies are needed on the subject.
Core stability is the motor control and muscle capacity of the lumbopelvic complex. Studies have shown that weakness in the core musculature can predispose an athlete to injury, including ankle sprains. Subjects with a history of lower extremity injuries require more trunk muscle contractions to stabilize the body during dynamic tasks compared to healthy subjects. Therefore, core muscles are an important element to be evaluated in athletes with chronic ankle instability. Although the relationship between chronic ankle instability and the strength of the core muscles has been examined in the literature, the relationship between them has not been fully explained.
In this study, the relationship between chronic ankle instability and core stabilization, dynamic balance and agility in Yeditepe University basketball players will be discussed and the results will be presented.
The power analysis of the research was made using the G*Power 3.1 program. The power of the study was determined as 80%. In a similar study, the mean of the Y balance test in individuals with chronic ankle instability was reported as 86.61, standard deviation of 3.98, and standard deviation of 9.51 in individuals without chronic ankle instability. Based on these values, power analysis was made with the G*Power 3.1 program. As a result of the analysis made with 80% power, the number of participants in the experimental and control groups was determined as 10 for each group.
SPSS (version 22.0) will be used in the data analysis of our research. Quantitative data to be obtained from the research will be shown as mean and standard deviation. Kolmogorov-Smirnov test will be used to test numerical variables for normality. According to the conformity of the obtained data to the normal distribution; If the data is normally distributed (parametric), Independent Sample t-test will be used to compare the two groups. If the data are not normally distributed, the Mann-Whitney U test will be used to compare the two groups. Qualitative data of the groups will be displayed with frequency and percentage values. The statistical significance level will be accepted as p<0.05.
- Conditions
- Ankle Sprains, Ankle Injuries, Chronic Ankle Instability
- Keywords
- chronic ankle instability, ankle instability, core stability, agility, dynamic balance, balance
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic ankle instability group | After completing the evaluation form containing the demographic and clinical characteristics of all participants at their first visit, the Cumberland Ankle Instability Questionnaire (CAIT) scale will be completed and athletes with a CAIT score ≤ 25 will be assigned to the Chronic Ankle Instability Group; | |
| Control group | Athletes with a score > 25 in the Cumberland Ankle Instability Questionnaire (CAIT) will be included in the Control Group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core stabilization- McGill Trunk Muscle Endurance Test.
It will be measured with the McGill Trunk Muscle Endurance Test. The McGill Trunk Muscle Endurance Test consists of 4 different positions: trunk anterior flexor test, right and left lateral plank, and trunk posterior extensor test. Before starting the test, participants are given a practice test in which they try to position the correct position for a few seconds, and a practice test in which they try to stay maximally static in each position. The investigator visually determines the end of all tests to ensure test reliability. This researcher uses the "start" and "stop" commands to start and end the test, while the co-investigator records times using a stopwatch.
Measured: 8 weeks
Dynamic balance- Y Balance Test
It will be measured with the Y Balance Test. The test apparatus is placed by measuring 90 degrees and 135 degrees in 3 directions, anterior, posteromedial and posterolateral.Before starting the test, subjects will be allowed to try each aspect 3 times.
Participants are asked to reach as far as they can without losing their balance. Distances will then be noted. The test is repeated 3 times in each direction. Participants will be given a 15-second rest period after each direction attempt. The average of the 3 repetitions reached for each of the three directions will be recorded. Normalized reach distances for all directions will be calculated by dividing the mean of the 3 measured replicates by the measured lower extremity length extending from the participants' SIAS to the distal apex of the medial malleolus and multiplying by 100.
Measured: 8 weeks
Agility- T Test
It will be measured with the T Test. The T-test consists of 4 contact points formed in a T-shape in an area 10 m long and 10 m wide. It is aimed to complete a series that requires the person to move in different directions and in different ways between these contact points as soon as possible. After three applications, the best test result is recorded in seconds.
Measured: 8 weeks
Secondary outcomes (1)
Physical functions of athletes with chronic ankle instability
It will be assessed with the The Foot and Ankle Ability Measure (FAAM). The Foot and Ankle Ability Measure will be used to measure the physical functions of athletes with chronic ankle instability. The FAAM consists of 29 items that present two separate subscales: "Activity of Daily Living" consisting of 21 questions and "Sports" consisting of 8 questions. Each question is rated from 0 to 4 with 0 "I can't" and 4 "no difficulty". Each subscale has a maximum potential score (84 ADL and 32 Sports subscales). The score for each subscale is divided by the maximum potential score for the subscale and multiplied by 100 to get a percentage. Therefore, the Foot and Ankle Usability Criterion has two subscales (ADL and Sport) with values ranging from 0 to 100, where higher values mean more physical function.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start5 Dec 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Urhun, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441319
- Sponsor's protocol ID
- yeditepe12
- Status last verified
- Mar 2023
- First submitted
- 28 Jun 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Urhun E, Develi E. Investigation of the effect of chronic ankle instability on core stabilization, dynamic balance and agility among basketball players of a university. J Bodyw Mov Ther. 2024 Oct;40:332-338. doi: 10.1016/j.jbmt.2024.04.036. Epub 2024 Apr 20.
PubMed 39593606
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Chronic Ankle Instability on Core Stabilization, Dynamic Balance and Agility in Basketball Players of an University
- ClinicalTrials.gov ID
- NCT05441319
- Acronym / sponsor ID
- yeditepe12
- Conditions
- Ankle Sprains, Ankle Injuries, Chronic Ankle Instability
- Keywords
- chronic ankle instability, ankle instability, core stability, agility, dynamic balance, balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 1 Jul 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.
Ankle sprains are the most common injury in basketball, especially involving repetitive maneuvers such as acceleration, deceleration, jumping, and landing. The incidence of ankle sprain is 40% in female basketball players and 75% in male basketball players. It is also known that chronic ankle instability (CAI) develops in 20-40% of cases. The effects of chronic ankle instability on core stabilization, dynamic balance and agility in basketball players have been investigated in the literature, and it has been stated that more studies are needed on the subject.
The aim of this study is to examine the effects of chronic ankle instability on core stabilization, dynamic balance and agility in basketball players playing in the university team.
The hypothesis of the study is that there is a difference between core stabilization, dynamic balance and agility values of basketball players playing in the university team with and without chronic ankle instability.
Detailed description
Approximately 10% to 28% of all sports injuries are ankle sprains. Ankle sprains are the most common injury in basketball, especially involving repetitive maneuvers such as acceleration, deceleration, jumping, and landing. The incidence of ankle sprain is 40% in female basketball players and 75% in male basketball players. It is also known that chronic ankle instability (CAI) develops in 20-40% of cases. People with CAI have several types of deficits, including decreased ankle range of motion, decreased ankle arthrokinematic quality of movement, problems with postural control and strength, impaired proprioception and neuromuscular control, and altered gait patterns. These problems can cause loss of matches, increase in health expenditures and future injuries in athletes. Postural control disorders that play a role in the regulation of balance have been shown to be common in people with CAI and after acute lateral ankle sprain. Postural control requires somatosensory, visual and vestibular stimuli and appropriate motor response to generate the appropriate balance response. In individuals with CAI, the ankle joint and postural control mechanisms that cannot receive appropriate afferent stimulation and cannot reveal the correct efferent stimulation from the central nervous system are impaired.
Agility, the ability to make rapid changes in the direction of movement, is widely regarded as an important criterion for success in basketball. Agility tests require rapid deceleration, change of direction, and reacceleration during movements. Such activities put athletes in a condition that can force the ankle complex into excessive inversion and plantar flexion, which often causes ankle sprain.
The relationship between chronic ankle instability and athletic performance parameters has been investigated in previous studies. However, the relationship between chronic ankle instability and athletic performance parameters has not yet been fully explained, and it has been stated that more studies are needed on the subject.
Core stability is the motor control and muscle capacity of the lumbopelvic complex. Studies have shown that weakness in the core musculature can predispose an athlete to injury, including ankle sprains. Subjects with a history of lower extremity injuries require more trunk muscle contractions to stabilize the body during dynamic tasks compared to healthy subjects. Therefore, core muscles are an important element to be evaluated in athletes with chronic ankle instability. Although the relationship between chronic ankle instability and the strength of the core muscles has been examined in the literature, the relationship between them has not been fully explained.
In this study, the relationship between chronic ankle instability and core stabilization, dynamic balance and agility in Yeditepe University basketball players will be discussed and the results will be presented.
The power analysis of the research was made using the G*Power 3.1 program. The power of the study was determined as 80%. In a similar study, the mean of the Y balance test in individuals with chronic ankle instability was reported as 86.61, standard deviation of 3.98, and standard deviation of 9.51 in individuals without chronic ankle instability. Based on these values, power analysis was made with the G*Power 3.1 program. As a result of the analysis made with 80% power, the number of participants in the experimental and control groups was determined as 10 for each group.
SPSS (version 22.0) will be used in the data analysis of our research. Quantitative data to be obtained from the research will be shown as mean and standard deviation. Kolmogorov-Smirnov test will be used to test numerical variables for normality. According to the conformity of the obtained data to the normal distribution; If the data is normally distributed (parametric), Independent Sample t-test will be used to compare the two groups. If the data are not normally distributed, the Mann-Whitney U test will be used to compare the two groups. Qualitative data of the groups will be displayed with frequency and percentage values. The statistical significance level will be accepted as p<0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic ankle instability group | – | –After completing the evaluation form containing the demographic and clinical characteristics of all participants at their first visit, the Cumberland Ankle Instability Questionnaire (CAIT) scale will be completed and athletes with a CAIT score ≤ 25 will be assigned to the Chronic Ankle Instability Group; |
| Control group | – | –Athletes with a score > 25 in the Cumberland Ankle Instability Questionnaire (CAIT) will be included in the Control Group. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- It is planned to include athletes aged 18-25, who play in university basketball teams, with and without chronic ankle instability in our study. It will include students between the ages of 18-25 who study at Yeditepe University and play in Yeditepe University basketball teams.
Key inclusion criteria (6 listed)
- To be a voluntary participant in the research.
- To be between the ages of 18-25.
- Experiencing recurrent sprains with inflammatory symptoms (pain, swelling) for individuals in the study group whose initial history of sprains was at least 1 year prior to the study.
- Playing in the basketball team for at least 1 season.
- Having a "feeling of insecurity" and instability in the injured ankle as verified by the Cumberland Ankle Instability Tool (CAIT) score of ≤25 for individuals in the research group.
Key exclusion criteria (8 listed)
- History of surgery for musculoskeletal structures in both lower extremities
- History of fracture in both lower extremities
- Acute injury of the musculoskeletal structures of other joints of the lower extremity affecting joint function and integrity in the last 3 months
- Presence of bilateral ankle instability
- Balance or vestibular disorder
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
Core stabilization- McGill Trunk Muscle Endurance Test.
Time frame: 8 weeks
It will be measured with the McGill Trunk Muscle Endurance Test. The McGill Trunk Muscle Endurance Test consists of 4 different positions: trunk anterior flexor test, right and left lateral plank, and trunk posterior extensor test. Before starting the test, participants are given a practice test in which they try to position the correct position for a few seconds, and a practice test in which they try to stay maximally static in each position. The investigator visually determines the end of all tests to ensure test reliability. This researcher uses the "start" and "stop" commands to start and end the test, while the co-investigator records times using a stopwatch.
Dynamic balance- Y Balance Test
Time frame: 8 weeks
It will be measured with the Y Balance Test. The test apparatus is placed by measuring 90 degrees and 135 degrees in 3 directions, anterior, posteromedial and posterolateral.Before starting the test, subjects will be allowed to try each aspect 3 times. Participants are asked to reach as far as they can without losing their balance. Distances will then be noted. The test is repeated 3 times in each direction. Participants will be given a 15-second rest period after each direction attempt. The average of the 3 repetitions reached for each of the three directions will be recorded. Normalized reach distances for all directions will be calculated by dividing the mean of the 3 measured replicates by the measured lower extremity length extending from the participants' SIAS to the distal apex of the medial malleolus and multiplying by 100.
Agility- T Test
Time frame: 8 weeks
It will be measured with the T Test. The T-test consists of 4 contact points formed in a T-shape in an area 10 m long and 10 m wide. It is aimed to complete a series that requires the person to move in different directions and in different ways between these contact points as soon as possible. After three applications, the best test result is recorded in seconds.
1 secondary outcome
Physical functions of athletes with chronic ankle instability
Time frame: 8 weeks
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 31 Mar 2023.
- Derived from this study: PubMed 39593606Urhun E, Develi E. Investigation of the effect of chronic ankle instability on core stabilization, dynamic balance and agility among basketball players of a university. J Bodyw Mov Ther. 2024 Oct;40:332-338. doi: 10.1016/j.jbmt.2024.04.036. Epub 2024 Apr 20.
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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 Sprains and Ankle Injuries, run by Yeditepe 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 6 inclusion and 8 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 31 Mar 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?
Core stabilization- McGill Trunk Muscle Endurance Test. (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05441319, which also lists 1 linked publication.
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 31 Mar 2023.