Evaluation of Ankle Propriocement and Stability
- Conditions
- Ankle SprainsInstability, Joint
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rizzoli Orthopaedic Institute
🇮🇹Bologna, BO, Italy
Rizzoli Orthopaedic Institute🇮🇹Bologna, BO, Italy