Chronic Ankle Instability Diagnostic Tests Determining Underlying Deficits

NCT ID: NCT03818438

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-24
• Study Completion Date: 2021-10-25

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.

Conditions

Ankle Dislocation; Chronic Ankle Instability

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Healthy subjects

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Arnould, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

CH Saint-Omer, institut audomarois de la chirurgie orthopédique et du sport

Saint-Omer, , France

Countries

France

Other Identifiers

2018-A00102-53

Identifier Type: OTHER

Identifier Source: secondary_id

2017_09

Identifier Type: -

Identifier Source: org_study_id