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At a glance

ClinicalIndex Comparison Record
N/ACompleted· 130 enrolled
Drug / intervention
Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical testsother
Likely dose
Not stated in record
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Search/NCT05331365
NCT05331365N/ACompleted

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

Elsan·interventional·Posted Apr 15, 2022·Updated Mar 29, 2024

In Brief

A clinical study evaluating Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests for Ankle Sprains and Ligament Sprain. Completed, enrolled 130 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 15, 2022
Enrollment StartMay 12, 2022
Primary CompletionMar 1, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.2 years ago

Interventions

Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical testsother

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