Chronic Ankle InstabilityNCT05732168
A Test Battery for Evaluation of Muscle Strength, Balance and Functional Performance in Subjects With Chronic Ankle Instability
An observational study of Chronic Ankle Instability, run by Linnaeus University at 1 site in Sweden.
Trial summary
Purpose: The primary aim of this study was to investigate subjects with chronic ankle instability regarding strength, balance and functional performance with an easily used test battery that required minimal equipment. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- A test battery for evaluation of muscle strength, balance and functional performance
- How many people
- 35 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2021to 8 Dec 2022
- How long will I take part?
- 1 Day
- 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 15 to 40 years
- All sexes
- Child, Adult
Study population: A total of 27 CAI received an invitation to participate. Four subjects were excluded due to newly injured ankle, two due to bilateral ankle instability and one because of previous problems but not in the past year. Finally, 20 CAI subjects were included in the analysis (Table 1). The subjects were involved in floorball (n=8), running (n=5), football (n=5), equestrian sports (n=1) and gymnastics (n=1). In addition, a convenience sample of 15 healthy subjects were also recruited in order to establish the specificity and accuracy of the test battery.
Who may be able to join
- Unilateral ankle problems
- Aged 15-40 years
- Minimum three recurrent sprains in the past year
Who cannot join
- previous ankle fracture with internal fixation surgery
- disease / illness that could have a general effect on the balance or strength
- newly sprained/injured in the current ankle within a period of eight weeks before the test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Test Battery for Evaluation of Muscle Strength, Balance and Functional Performance in Subjects With Chronic Ankle Instability: a Cross-sectional Study
Purpose: The primary aim of this study was to investigate subjects with chronic ankle instability regarding strength, balance and functional performance with an easily used test battery that required minimal equipment. A second aim was to evaluate which of these tests that has the highest ability to discriminate impaired function between injured and non-injured ankle in CAI subjects.
Methods: This study was conducted with a cross-sectional design. A total of 20 (11 women) CAI subjects, engaged in sports, were tested for assessment of strength, balance and functional performance using the following tests; isometric strength in inversion and eversion, the single leg stance test (SLS), single leg hop for distance (SLHD) and side hop test. Additionally, 15 healthy subjects were tested with the same test battery for the evaluation of
Read the detailed description
Study design and procedure Data for cross-sectional study, adhering to the STROBE statement were collected during 2021-2022 where subjects with chronic ankle instability (CAI) were evaluated with tests of strength, balance and functional performance.
Outcome measures The primary outcome was ankle function, in subjects with CAIs, which was assessed by a test battery consisting of two muscle strength tests, one balance test and two functional performance tests.
Muscle strength Ankle inversion and eversion isometric muscle strength were assessed using hand-held dynamometry, MicroFET2 (Hoggan Health Industries, Inc., Draper, UT). The subjects were examined in a lying in a prone position with the feet outside the edge with one test leader stabilizing the subject's lower leg. Before the test, the subjects tried the directions against the test leader's hand. Three maximal isometric contractions, measured in Newton (N) with 15 secs of rest between each contraction, were measured and the best attempt was used for further analysis. Five minutes of rest was used when changing test direction.
The single leg stance test (SLS) Balance was measured with the Single-leg stance test (SLS). The test began with the subject standing on one leg, with his arms straight down, and the other leg held against the calf of the standing leg. When standing steadily, the subject was asked to close their eyes and maintain balance without using opposite legs or arms. The number of times the subject corrected his balance, during 30 sec, was documented as part foot lifts. Part foot lift was defined as all parts of the foot that left the surface, e.g. toes, outside foot, heel. Putting down the opposite leg also counted as part foot lift. The total number of part foot lifts constituted a score that was used as a result.
Functional performance Functional performance was assessed by the Single-leg hop for distance (SLHD) and the 30-sec timed side hop test. Before each test, the subject had to perform three submaximal test jumps.
For the SLHD, the subject was standing on one leg with the other leg lifted from the floor. Free leg swing was allowed but the hands was placed behind the back. The subject jumped forward as far as possible, taking off and landing on same foot with a controlled landing. The subject had to maintain balance on landing until the test leader had registered the landing position, approximately (2-3 s). The distance was measured in centimeters from the toe at the push-off to the heel where the subject landed.
For the side hop test, the subject stood on the test leg, with the other leg lifted from the floor, and hands placed behind the back. Two parallel strips of tape, placed 40 cm apart on the floor was used and the subject jumped from side to side as many times as possible during a period of 30 s. The number of successful jumps performed, without touching the tape, was recorded and will be used for further analysis.
Sample size calculation Based on a power of 0.80 (α =0.05), approximately 18 CAI subjects would be required to detect a 20 % difference between injured and non-injured ankle in the balance test score. Twenty percent was considered as a minimal clinically relevant difference. Therefore, this study was planned to recruit a minimum of 25 CAI subjects with regard for potential dropouts.
Statistical analysis plan Statistics will be calculated using IBM SPSS (IBM SPSS Statistics for Windows, Version 27.0. IBM, Armonk, NY). Differences in strength, balance and functional performance, between injured and non-injured ankle, will be analyzed with the Wilcoxon rank test. The Spearman's correlation coefficient will be used to analyze the association between the different tests.
The limb symmetry index (LSI) will be calculated to determine whether a side-to-side lower limb difference could be classified as normal or abnormal. The LSI is defined as the ratio of the score of the injured ankle and the score of the non-injured ankle, expressed in percent (injured/non-injured x 100 = LSI).
- Conditions
- Chronic Ankle Instability
- Being tested
- A test battery for evaluation of muscle strength, balance and functional performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A test battery for evaluation of muscle strength, balance and functional performanceDiagnostic test
Subjects with chronic ankle instability (CAI) were evaluated with five tests of strength, balance and functional performance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with chronic ankle instability | Men and women with recurrent unilateral ankle instability problems Receives: Diagnostic Test: A test battery for evaluation of muscle strength, balance and functional performance | |
| Control group | Healthy men and women without ankle problems Receives: Diagnostic Test: A test battery for evaluation of muscle strength, balance and functional performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength measured in Newton
Ankle inversion and eversion isometric muscle strength measured with a handheld dynometer and measured in Newton
Measured: 1 day
Balance
Balance assessed by the Single-leg stance test (SLS) and measured in number of footlifts
Measured: 1 day
Functional performance assessed with the SLHD test measured in centimeters
Functional performance assessed with the SLHD test measured in centimeters for the total distance. The athlete stands on one leg and then jump as far as possible and land on the same leg. The best of three attempts will be used for further analysis.
Measured: 1 day
Functional performance assessed with the side hop test and measured as the number of repetitions
Functional performance assessed with the side hop test and measured as the number of repetitions. Two parallel strips of tape is placed 40 cm apart on the floor. The athlete stands on one leg, with the hands behind the back, and jumps from side to side between the two strips. The athlete jumps as many times as possible during a period of 30 s. The number of successful jumps performed, without touching the tape, is recorded.
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 posted16 Feb 2023
- Study start1 Jan 2021
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
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 Chronic Ankle InstabilityStudies 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
- 35 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Linnaeus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Ryman Ryman Augustsson, Linnaeus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732168
- Sponsor's protocol ID
- EPK 676 - 2021
- Status last verified
- Mar 2023
- First submitted
- 24 Jan 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ryman Augustsson S, Sjostedt E. A test battery for evaluation of muscle strength, balance and functional performance in subjects with chronic ankle instability: a cross-sectional study. BMC Sports Sci Med Rehabil. 2023 Apr 13;15(1):55. doi: 10.1186/s13102-023-00669-5.
PubMed 37055818
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Test Battery for Evaluation of Muscle Strength, Balance and Functional Performance in Subjects With Chronic Ankle Instability: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05732168
- Acronym / sponsor ID
- EPK 676 - 2021
- Conditions
- Chronic Ankle Instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Linnaeus UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 16 Feb 2023 (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.
Purpose: The primary aim of this study was to investigate subjects with chronic ankle instability regarding strength, balance and functional performance with an easily used test battery that required minimal equipment. A second aim was to evaluate which of these tests that has the highest ability to discriminate impaired function between injured and non-injured ankle in CAI subjects.
Methods: This study was conducted with a cross-sectional design. A total of 20 (11 women) CAI subjects, engaged in sports, were tested for assessment of strength, balance and functional performance using the following tests; isometric strength in inversion and eversion, the single leg stance test (SLS), single leg hop for distance (SLHD) and side hop test. Additionally, 15 healthy subjects were tested with the same test battery for the evaluation of
Detailed description
Study design and procedure Data for cross-sectional study, adhering to the STROBE statement were collected during 2021-2022 where subjects with chronic ankle instability (CAI) were evaluated with tests of strength, balance and functional performance.
Outcome measures The primary outcome was ankle function, in subjects with CAIs, which was assessed by a test battery consisting of two muscle strength tests, one balance test and two functional performance tests.
Muscle strength Ankle inversion and eversion isometric muscle strength were assessed using hand-held dynamometry, MicroFET2 (Hoggan Health Industries, Inc., Draper, UT). The subjects were examined in a lying in a prone position with the feet outside the edge with one test leader stabilizing the subject's lower leg. Before the test, the subjects tried the directions against the test leader's hand. Three maximal isometric contractions, measured in Newton (N) with 15 secs of rest between each contraction, were measured and the best attempt was used for further analysis. Five minutes of rest was used when changing test direction.
The single leg stance test (SLS) Balance was measured with the Single-leg stance test (SLS). The test began with the subject standing on one leg, with his arms straight down, and the other leg held against the calf of the standing leg. When standing steadily, the subject was asked to close their eyes and maintain balance without using opposite legs or arms. The number of times the subject corrected his balance, during 30 sec, was documented as part foot lifts. Part foot lift was defined as all parts of the foot that left the surface, e.g. toes, outside foot, heel. Putting down the opposite leg also counted as part foot lift. The total number of part foot lifts constituted a score that was used as a result.
Functional performance Functional performance was assessed by the Single-leg hop for distance (SLHD) and the 30-sec timed side hop test. Before each test, the subject had to perform three submaximal test jumps.
For the SLHD, the subject was standing on one leg with the other leg lifted from the floor. Free leg swing was allowed but the hands was placed behind the back. The subject jumped forward as far as possible, taking off and landing on same foot with a controlled landing. The subject had to maintain balance on landing until the test leader had registered the landing position, approximately (2-3 s). The distance was measured in centimeters from the toe at the push-off to the heel where the subject landed.
For the side hop test, the subject stood on the test leg, with the other leg lifted from the floor, and hands placed behind the back. Two parallel strips of tape, placed 40 cm apart on the floor was used and the subject jumped from side to side as many times as possible during a period of 30 s. The number of successful jumps performed, without touching the tape, was recorded and will be used for further analysis.
Sample size calculation Based on a power of 0.80 (α =0.05), approximately 18 CAI subjects would be required to detect a 20 % difference between injured and non-injured ankle in the balance test score. Twenty percent was considered as a minimal clinically relevant difference. Therefore, this study was planned to recruit a minimum of 25 CAI subjects with regard for potential dropouts.
Statistical analysis plan Statistics will be calculated using IBM SPSS (IBM SPSS Statistics for Windows, Version 27.0. IBM, Armonk, NY). Differences in strength, balance and functional performance, between injured and non-injured ankle, will be analyzed with the Wilcoxon rank test. The Spearman's correlation coefficient will be used to analyze the association between the different tests.
The limb symmetry index (LSI) will be calculated to determine whether a side-to-side lower limb difference could be classified as normal or abnormal. The LSI is defined as the ratio of the score of the injured ankle and the score of the non-injured ankle, expressed in percent (injured/non-injured x 100 = LSI).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with chronic ankle instability | – | Diagnostic Test: A test battery for evaluation of muscle strength, balance and functional performanceMen and women with recurrent unilateral ankle instability problems |
| Control group | – | Diagnostic Test: A test battery for evaluation of muscle strength, balance and functional performanceHealthy men and women without ankle problems |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- A total of 27 CAI received an invitation to participate. Four subjects were excluded due to newly injured ankle, two due to bilateral ankle instability and one because of previous problems but not in the past year. Finally, 20 CAI subjects were included in the analysis (Table 1). The subjects were involved in floorball (n=8), running (n=5), football (n=5), equestrian sports (n=1) and gymnastics (n=1). In addition, a convenience sample of 15 healthy subjects were also recruited in order to establish the specificity and accuracy of the test battery.
Key inclusion criteria (3 listed)
- Unilateral ankle problems
- Aged 15-40 years
- Minimum three recurrent sprains in the past year
Key exclusion criteria (3 listed)
- previous ankle fracture with internal fixation surgery
- disease / illness that could have a general effect on the balance or strength
- newly sprained/injured in the current ankle within a period of eight weeks before the test
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 |
|---|---|---|
| A test battery for evaluation of muscle strength, balance and functional performanceSubjects with chronic ankle instability (CAI) were evaluated with five tests of strength, balance and functional performance. | Diagnostic test | Control group, Subjects with chronic ankle instability |
Primary outcome
Muscle strength measured in Newton
Time frame: 1 day
Ankle inversion and eversion isometric muscle strength measured with a handheld dynometer and measured in Newton
Balance
Time frame: 1 day
Balance assessed by the Single-leg stance test (SLS) and measured in number of footlifts
Functional performance assessed with the SLHD test measured in centimeters
Time frame: 1 day
Functional performance assessed with the SLHD test measured in centimeters for the total distance. The athlete stands on one leg and then jump as far as possible and land on the same leg. The best of three attempts will be used for further analysis.
Functional performance assessed with the side hop test and measured as the number of repetitions
Time frame: 1 day
Functional performance assessed with the side hop test and measured as the number of repetitions. Two parallel strips of tape is placed 40 cm apart on the floor. The athlete stands on one leg, with the hands behind the back, and jumps from side to side between the two strips. The athlete jumps as many times as possible during a period of 30 s. The number of successful jumps performed, without touching the tape, is recorded.
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 6 Mar 2023.
- Derived from this study: PubMed 37055818Ryman Augustsson S, Sjostedt E. A test battery for evaluation of muscle strength, balance and functional performance in subjects with chronic ankle instability: a cross-sectional study. BMC Sports Sci Med Rehabil. 2023 Apr 13;15(1):55. doi: 10.1186/s13102-023-00669-5.
- Individual participant dataSharing planned: No
Related trials for Chronic Ankle Instability
Recruiting
Neurocognitive Enrichment During Functional Performance Testing in Chronic Ankle Instability
Chronic Ankle Instability, CAI
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
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 Chronic Ankle Instability, run by Linnaeus University at 1 site in Sweden.
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 3 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 6 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 Sweden. 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?
Muscle strength measured in Newton (time frame: 1 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?
On the ClinicalTrials.gov record for NCT05732168, 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 6 Mar 2023.