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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Sweden1 site
  • Sofia Ryman Augustsson

    Kalmar, 391 82

Other trials in Sweden

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).

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 groups in NCT05732168
Study groupRoleWhat they receive
Subjects with chronic ankle instabilityMen and women with recurrent unilateral ankle instability problems
Receives: Diagnostic Test: A test battery for evaluation of muscle strength, balance and functional performance
Control groupHealthy 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.

  1. Muscle strength measured in Newton

    Ankle inversion and eversion isometric muscle strength measured with a handheld dynometer and measured in Newton

    Measured: 1 day

  2. Balance

    Balance assessed by the Single-leg stance test (SLS) and measured in number of footlifts

    Measured: 1 day

  3. 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

  4. 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.

  1. First posted16 Feb 2023
  2. Study start1 Jan 2021
  3. Primary completion8 Dec 2022
  4. Study completion8 Dec 2022

Resources

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
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

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.

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