Clinical trial NCT03818438: Chronic Ankle Instability Diagnostic Tests Determining Underlying Deficits
Official title: Biomechanical Analysis, Complementary Examinations and Rehabilitative Management of Chronic Ankle Instability
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ankle Dislocation
Chronic Ankle Instability
Keywords: Chronic instability
Strength
Proprioception
Rehabilitation
Ankle
Balance
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2019-01-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Static balance tests
timeFrame: Baseline
measure: the Star Excursion Balance Test (SEBT)
timeFrame: Baseline
measure: Hop tests
timeFrame: Baseline
measure: Strength tests (both ankles tested)
timeFrame: Baseline
Secondary outcomes:
measure: Intra-class correlation coefficients (reproducibility test-retest)
timeFrame: Baseline and 1-4 weeks after baseline
Other outcomes:
Locations:
city: Saint-Omer
country: France
facility: CH Saint-Omer, institut audomarois de la chirurgie orthopédique et du sport
Study officials:
affiliation: University Hospital, Lille
name: Alexandre Arnould, MD
role: PRINCIPAL_INVESTIGATOR
References: