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TerminatedNCT03818438CAIDiagUpdated May 31, 2022

Chronic Ankle Instability Diagnostic Tests Determining Underlying Deficits

An observational study in Ankle Dislocation and Chronic Ankle Instability, sponsored by University Hospital, Lille. Terminated at 1 site in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-31.

Sponsored by University Hospital, Lille · Observational

Why this study was terminated
insufficiency inclusion; covid crisis ; sponsor decision
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
4
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Chronic ankle instability is a common condition in the active adult population and characterized by the occurrence of repeated giving way and/or recurrent ankle sprains. Multiple underlying deficits have been proposed, among which ankle muscle strength deficits, proprioception deficits, ( static and dynamic balance disorders, and articular laxity. Unfortunately, no consensus exists on which clinical tests should be realized to determine if one of these underlying deficits is predominant and as a result could guide the rehabilitation process. The study hypothesis is that people with chronic ankle instability might be heterogenous and could be divided in different subgroups as a function of underlying deficits. Therefore, this study aims to evaluate the capacity of different clinical tests to differentiate people with chronic ankle instability from healthy people as well as between each other.

02

Conditions studied

  • Ankle Dislocation
  • Chronic Ankle Instability

Keywords

  • Chronic instability
  • Strength
  • Proprioception
  • Rehabilitation
  • Ankle
  • Balance
03

In context

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults (18-45 yrs) living in the northern part of France close to or in Lille, Saint-Omer and Amiens

Inclusion criteria

  • Case subject : at least one initial lateral ankle sprain more than 12 months before inclusion
  • Case subject : at least one residual symptom among (1) giving way, (2) sensation of instability, (3) recurrent ankle sprain. This item is confirmed by a score inferior than 24 on the Chronic Ankle Instability Tool (CAIT)
  • Case subject : Impact on activities of daily living and sport, confirmed by a score of less than 90% on the Foot and Ankle Ability Measure (FAAM) and less than 80% on FAAM-- - -- Control subject : matched by age and sex to case subjects

Exclusion criteria

Exclusion Criteria:

  • Surgery of one of the lower limbs less than 3 years ago
  • Presence of heavy pain (EVA > 8) regardless of its origin
  • Acute lateral ankle sprain less than 4 months before inclusion
  • Neurological disorders of any kind
  • Medical treatment (drugs) interfering with muscle tone, balance and proprioception disorders
  • Pregnant or breastfeeding women
  • Body mass index > 30
  • Bilateral chronic ankle instability
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
4 participants (actual)
Patient registry
No

Groups and cohorts

  • Case subjects adult patients with chronic ankle instability

    Male or female subjects aged 18-45, presenting : * at least one acute lateral ankle sprain (i.e. initial ankle sprain more than 12 months before inclusion), * at least one residual symptom (giving way OR sensation of instability OR recurrent ankle sprain), confirmed by a score \< 24 on the Chronic Ankle Instability Tool (CAIT) * Impact on activities of daily living and sport, score \< 90% on Foot and Ankle Ability Measure (FAAM) and \< 80% on FAAM-sport Case subjects are free of any other lower extremity pathologies or pain Subjects presenting bilateral chronic ankle instability are excluded

  • Healthy subjects

    Male or female subjects aged 18-45 (matched with case Healthy subjects), without any lower extremity pathologies

06

What researchers measure

Primary outcomes

  1. Static balance tests

    Static balance tests ( DLS and SLS (both ankles tested) ; Stabilometry) are composite measure * Centre of Pressure (COP) displacement (mm) ; * COP velocity (mm/s) * COP area (mm²) * COP time-to-boundary (TTB) (s) * Number of foot lifts (integer)

    Time frame: Baseline

  2. the Star Excursion Balance Test (SEBT)

    Dynamic balance test : SEBT (both ankles tested) : are composite measure * Distance reached in anterior direction (% leg length) * Distance reached in posteromedial direction (% leg length) * Distance reached in posterolateral direction (% leg length) * Time used to reach (s) * COP displacement (mm) * COP velocity (s) * COP area (mm²) * COP time-to-boundary (TTB) (s)

    Time frame: Baseline

  3. Hop tests

    Hop tests (both ankles tested) : SLHD et SH ; are composite measure * Distance reached (m) * Max inversion angle ankle joint (°) * Max internal rotation angle ankle joint (°) * Max vertical Ground Reaction Force (GRF) at landing (N) * Max lateral GRF (N) * Time used to complete 10 hops (s)

    Time frame: Baseline

  4. Strength tests (both ankles tested)

    Isokinetic strength tests (both ankles tested) : * Plantar flexor peak torque (Nm) * Dorsiflexor peak torque (Nm) * Inversion peak torque (Nm) * Eversion Peak torque (Nm)

    Time frame: Baseline

Secondary outcomes

  1. Intra-class correlation coefficients (reproducibility test-retest)

    Intra-class correlation coefficients (reproducibility test-retest) calculated on the subset of the parameters identified by the main analysis. Recyclability of the functional clinical tests : Normality testing /Sample comparison

    Time frame: Baseline and 1-4 weeks after baseline

07

Study locations

1 site
  • CH Saint-Omer, institut audomarois de la chirurgie orthopédique et du sport
    Saint-Omer, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03818438
Lead sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
Jan 28, 2019
Start date
Oct 24, 2019
Primary completion
Oct 25, 2021
Completion
Oct 25, 2021
Last update
May 31, 2022

Study contacts

Alexandre Arnould, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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