NCT05331365

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Elsan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Ankle Sprains
• Ligament Sprain

Interventions

Type	Name	Description
OTHER	Construction 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

Timeline

• Start date: 2022-05-12
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2022-04-15
• Last updated: 2024-03-29

Locations

1 site across 1 country: France