Evaluation of Ankle Propriocement and Stability

Not Applicable

Completed

• Conditions: Ankle Sprains; Instability, Joint
• Interventions: Procedure: Preoperative evaluation; Procedure: Postoperative evaluation

• Registration Number: NCT04362488
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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

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)

Study Timeline

• Study Start: 2019-02-04
• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-27
• Primary Completion: 2022-02-01
• Study Completion: 2023-11-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with chronic post-traumatic lateral ankle instability	Preoperative evaluation	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)
Patients with chronic post-traumatic lateral ankle instability	Postoperative evaluation	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)

Primary Outcome Measures

Name	Time	Method
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire	End of the study, 18 month from the beginning (04 August 2020)	AOFAs: values from 0 to 100 dependent on limitations in performing activities
modified Star Excursional Balance Test (mSEBT) functional test	End of the study, 18 month from the beginning (04 August 2020)	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
Short Physical Performance Battery functional test	End of the study, 18 month from the beginning (04 August 2020)	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.
Delos (computerized oscillating platform)	End of the study, 18 month from the beginning (04 August 2020)	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.
Foot & Ankle Ability Measure (FAAM) questionnaire.	End of the study, 18 month from the beginning (04 August 2020)	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.
Short Form Health Survey - 12 questionnaire	End of the study, 18 month from the beginning (04 August 2020)	SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, BO, Italy