Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate post-operatively the postural control through the Delos system with the Riva method of patients already treated surgically of external capsulo-ligament reconstruction due to ankle instability.

Detailed Description
-----------------
The patients will then be divided into two control groups: one group will undergo reconditioning through the Delos system and one group will undergo standard rehabilitation treatment. Primary outcome: improvement of joint stability and postoperative proprioception after reconditioning with the Delos system. Secondary outcomes: improvement of performance indicators and reduction of disability and satisfaction and assessment of long-term ankle stability after reconditioning with Delos system.

Official Title
-----------------
Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability

Conditions
-----------------
Ankle Sprains, Instability, Joint

Intervention / Treatment
-----------------
* Device: Delos instrument (computerized balance board)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients already undergoing surgery and with at least 4 months of follow-up; 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 the willingness to reach the Hospital to carry out the checks. Exclusion Criteria: patients with BMI> 30 kg / m2; patients with rheumatoid arthritis; patients with chronic inflammatory joint diseases; patients with pre-existing deambulation kinematics abnormalities (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 severe postural instability; patients with cognitive impairments; patients with concomitant neurological diseases.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Proprioceptive training, which will be carried out 1 session lasting one hour twice per week for 5 weeks using Delos instrument with Riva method | Device: Delos instrument (computerized balance board)<br>* Proprioceptive training using Delos instrument (computerized balance board). Static and dynamic evaluation through Delos with the Riva method; Physiatric visit; Clinical scores (AOFAs); Functional scores (SPPB); SF12 satisfaction.<br>|
| No Intervention: Control group<br>Normal physiotherapy performed according to standard protocols. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static and Dynamic Stability Index | Evaluation of proprioception and mechanical stability of the post-operative ankle undergoing to reconditioning with a Delos device through Static and Dynamic Stability Index. | 5 weeks from the start of rehabilitation treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal perception of the patient | Subjective perception of the patient evaluated by administering clinical questionnaires (AOFAS ankle hindfoot) | 5 weeks from the start of rehabilitation treatment | 
| Clinical test | Stability of the ankle operated evaluated by clinical test | 5 weeks from the start of rehabilitation treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankle instability, Stabilometry