Chronic Ankle Instability Diagnostic Tests Determining Underlying Deficits

Chronic Ankle Instability Clinical Trial

— CAIDiag  

Official title:

Biomechanical Analysis, Complementary Examinations and Rehabilitative Management of Chronic Ankle Instability

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03818438
• Other study ID #: 2017_09
• Secondary ID: 2018-A00102-53
• Status: Terminated
• Start date: October 24, 2019
• Est. completion date: October 25, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Dislocation
• Chronic Ankle Instability

Locations

Country	Name	City	State
France	CH Saint-Omer, institut audomarois de la chirurgie orthopédique et du sport	Saint-Omer

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline
Primary	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)	Baseline
Primary	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)	Baseline
Primary	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)	Baseline
Secondary	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	Baseline and 1-4 weeks after baseline