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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic post-traumatic lateral ankle instability | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative evaluation | Procedure | Preoperative evaluation using differents clinical evaluation tests, questionnaires, and instrument:
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| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimiliano Mosca | Rizzoli Orthopaedic Istitute, Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rizzoli Orthopaedic Institute | Bologna | BO | 40126 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 | Feb 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D007593 | Joint Instability |
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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
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| Postoperative evaluation | Procedure | Postoperative evaluation at 4 months of follow up after surgery using differents clinical evaluation tests, questionnaires, and instrument:
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| 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) |