NCT05732168

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

January 24, 2023

Last Update Submit

March 2, 2023

Conditions

Chronic Ankle Instability

Outcome Measures

Primary Outcomes (4)

  • Muscle strength measured in Newton

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

    1 day

  • Balance

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

    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.

    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.

    1 day

Study Arms (2)

Subjects with chronic ankle instability

Men and women with recurrent unilateral ankle instability problems

Diagnostic Test: A test battery for evaluation of muscle strength, balance and functional performance

Control group

Healthy men and women without ankle problems

Diagnostic Test: A test battery for evaluation of muscle strength, balance and functional performance

Interventions

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.

Control groupSubjects with chronic ankle instability

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Unilateral ankle problems
  • Aged 15-40 years
  • Minimum three recurrent sprains in the past year

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sofia Ryman Augustsson

Kalmar, 391 82, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 37055818DERIVED

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 16, 2023

Study Start

January 1, 2021

Primary Completion

December 8, 2022

Study Completion

December 8, 2022

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)