Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty

Study Overview
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Brief Summary
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The goal of this prospective, open label study is the construction and the evaluation of a composite score evaluating the residual instability in patients who have undergone an ankle's ligamentoplasty (the Ankle Go Test score). The main hypothesis of this study is based on the fact that the composite score Ankle Go Test would allow a global validation of all the criteria of scores of 4 tests and 2 questionnaires, which are performed in common pratice, evaluating the instability of the ankle after an ankle ligamentoplasty. Participants will have to complete 2 questionnaires (FAAM, ALR RS) and to undergoe 4 tests (Single Leg Stance Test, Side Hop Test, Start Excursion Balance Test, La figure of 8), at 4, 6 and 12 months post surgery. Researchers will compare the group of participants who undergone ankle's ligamentoplasty with a group of healthy volunteers to assess the discriminant validity of the Ankle Go Test score

Official Title
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Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty - Ankle Go Study

Conditions
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Ankle Sprains, Ligament Sprain

Intervention / Treatment
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* Other: Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients who underwent arthroscopic ankle ligamentoplasty or healthy volunteers with no previous knee or ankle history. Age ≥ 18 years Patients who's been informed about the study and who didn't express their opposition to participate Exclusion Criteria: Patients with chronic ankle instability, operated or not, contralateral Patients under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who have undergone ankle ligamentoplasty 4 months ago will be included in the study. Healthy volunteers will be selected on a voluntary basis at the request of the investigators in the population of patients undergoing rehabilitation by physiotherapists at the investigation sites and with no history of knee or ankle problems.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group of the construction of the composite Ankle go score and internal validations<br>50 patients will be include for the construction of the composite score and its internal validations. They will complete questionnaires (FAAM, ALR-RSI) and undergo tests (SLSTS, SHTS, SEBT and Figure of 8) 4 months after ankle's surgery (visit 1), 6 months after surgery (visit 2) and 12 months post surgery | Other: Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests<br>* Four tests and two questionnaires, each evaluating specific physical or psychological dimensions will be used to construct the composite score Ankle Go Test composite score: Foot and Ankle Ability Measure Questionnaire (FAAM) Ankle ligament reconstruction-return to sport after injury Questionnaire(ALR-RSI) Single Leg Stance Test (SLST) Side Hop Test (SHT) Star Excursion Balance Test (SEBT) Figure-of-8<br>|
| Experimental: group of the external validation stage of the composite score<br>50 additional patients for the external validation stage of the composite score. They will complete questionnaires (FAAM, ALR-RSI) and undergo tests (SLSTS, SHTS, SEBT and Figure of 8) 4 months after ankle's surgery (visit 1) and 6 months after surgery (visit 2) | Other: Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests<br>* Four tests and two questionnaires, each evaluating specific physical or psychological dimensions will be used to construct the composite score Ankle Go Test composite score: Foot and Ankle Ability Measure Questionnaire (FAAM) Ankle ligament reconstruction-return to sport after injury Questionnaire(ALR-RSI) Single Leg Stance Test (SLST) Side Hop Test (SHT) Star Excursion Balance Test (SEBT) Figure-of-8<br>|
| No Intervention: Group allowing the assessment of the score's ability to discriminate<br>30 healthy volunteers (who did not undergone an ankle's surgery) will be included in the study to analyze the ability of composite score to discriminate. The healthy population will perform the same physical and psychological tests as Group allowing the construction of the composite Ankle go score and internal validations | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The construction of the  Ankle Go Test , composed of the scores obtained from the 4 tests and 2 questionnaires perfomed 6 months post ankle's surgery | Three steps will be required to construct the Ankle Go Test: Determining how much information the tests and questionnaires will contribute to the overall composite score (step 1) Construction of the score itself and extraction of a residual instability cut-off by the patient at 6 months post-intervention (step 2). Confirmation of the weighting and validation of the composite score and the cut-off using an external population (external validation; step 3) | At 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite score's sensibility to change (ability of the composite score to measure patients' progress) | The ability of the composite score to measure patients' progress will be measured by analysis of composite score results at 4 months, 6 months and 1 year post surgery | At 4 months, 6 months and 1 year post-intervention | 
| Reproductibility of the composite score | The reproductibility of the composite score will be measured by Analysis of composite score results at 24 hours interval. | At 6 months with interval of + 24 hours | 
| Discriminating ability of the composite score | Discriminating ability of the composite score will be measured by the Comparison of the composite score's results in post-operative patients to composite score's results in healthy volunteers | At 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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score, ligamentoplasty, chronic ankle instability