Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty - Ankle Go Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Patients with chronic ankle instability, operated or not, contralateral
- •Patients under legal protection
结局指标
主要结局
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
时间窗: 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)
次要结局
- Reproductibility of the composite score(At 6 months with interval of + 24 hours)
- 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)
- Discriminating ability of the composite score(At 6 months post-intervention)