Evaluation of Ankle Propriocement and Stability

Study Overview
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Brief Summary
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The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability.

Detailed Description
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The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability using differents tests, questionnaires and instrument: Delos system (computerized oscillating platform) Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)

Official Title
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Evaluation of Ankle Propriocement and Stability in Patients Affected by Traumatic Lateral Ankle Instability Before and After External Ankle Ligament Recontruction

Conditions
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Ankle Sprains, Instability, Joint

Intervention / Treatment
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* Procedure: Preoperative evaluation
* Procedure: Postoperative evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who must undergo surgery; patients of both sexes aged between 18-40 years; patients who have given their informed written consent to participate in the study; patients who have given their consent to reach the Hospital to perform the 4-month check-up Exclusion Criteria: patients with BMI> 30 kg / m2; patients with rheumatoid arthritis; patients with chronic inflammatory joint diseases; patients with pre-existing abnormalities of the ambulatory kinematics (amputations, neuro-muscular diseases, polio, hip dysplasias); patients with Severe arthrosis of the ankle (Kellgren-Lawrence> 3); patients with Severe knee arthritis (Kellgren-Lawrence> 3); patients with ACL injury; patients with severe postural instability; patients with cognitive impairments; patients with concomitant neurological diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All patients who undergo surgery for a ankle lateral ligament reconstruction from 4th Febbruary 2019 till to the end of the study on 4th August 2020
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with chronic post-traumatic lateral ankle instability<br>The study population consists in patients affected by chronic post-traumatic lateral ankle instability who must undergo surgical intervention of ankle external ligament reconstruction. The patients will be analyzed pre and postoperatively using differents tests, questionnaires, instrument and clinical evaluation: Delos system (computerized oscillating platform) Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB) | Procedure: Preoperative evaluation<br>* Preoperative evaluation using differents clinical evaluation tests, questionnaires, and instrument: Delos system (computerized oscillating platform) Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)<br>* Other names: Tests: mSEBT, SPPB;Procedure: Postoperative evaluation<br>* Postoperative evaluation at 4 months of follow up after surgery using differents clinical evaluation tests, questionnaires, and instrument: Delos system (computerized oscillating platform) Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)<br>* Other names: Tests: mSEBT, SPPB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delos (computerized oscillating platform) | The patients will be analyzed pre and postoperatively using a computerized oscillating platform that shows the response of the foot as an adaptation to the ground. The result is expressed through stability index (%) compared to the average of the population. | End of the study, 18 month from the beginning (04 August 2020) | 
| Foot & Ankle Ability Measure (FAAM) questionnaire. | FAAM: expresses the personal evaluation of the patient on his difficulty in performing activities using 5 values for each question: no difficulty, slight difficulty, moderate difficulty, extreme difficulty, inability. | End of the study, 18 month from the beginning (04 August 2020) | 
| American Orthopaedic Foot & Ankle score (AOFAs) questionnaire | AOFAs: values from 0 to 100 dependent on limitations in performing activities | End of the study, 18 month from the beginning (04 August 2020) | 
| Short Form Health Survey - 12 questionnaire | SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question. | End of the study, 18 month from the beginning (04 August 2020) | 
| modified Star Excursional Balance Test (mSEBT) functional test | mSEBT: best value resulting from the 3 equilibrium tests standardized for the length of the limb. The tests consist in reaching the greater distance with a foot along three (inverted Y-shaped) axes with between them an angle of 90 ° (rear) and two of 135 ° (antero-medial and anterior-lateral) while the opposite foot remains still on the ground | End of the study, 18 month from the beginning (04 August 2020) | 
| Short Physical Performance Battery functional test | The SPPB scale is a short battery of tests designed to evaluate the functionality of the lower limbs. This battery consists of 3 different sections. The total score of the scale has a range from 0 to 12. | End of the study, 18 month from the beginning (04 August 2020) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sprain, Brostrom, ankle instability