Ankle Sprains, Ligament Sprain
Conditions
Keywords
ligamentoplasty, chronic ankle instability, score
Brief summary
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
Interventions
OTHERConstruction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests
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
Sponsors
Elsan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male and female patients who underwent arthroscopic ankle ligamentoplasty or healthy volunteers with no previous knee or ankle history. 2. Age ≥ 18 years 3. Patients who's been informed about the study and who didn't express their opposition to participate
Exclusion criteria
1. Patients with chronic ankle instability, operated or not, contralateral 2. Patients under legal protection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At 6 months post-intervention | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The composite score's sensibility to change (ability of the composite score to measure patients' progress) | At 4 months, 6 months and 1 year post-intervention | 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 |
| Reproductibility of the composite score | At 6 months with interval of + 24 hours | The reproductibility of the composite score will be measured by Analysis of composite score results at 24 hours interval. |
| Discriminating ability of the composite score | At 6 months post-intervention | 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 |
Countries
France
Outcome results
None listed