Clinical trial NCT04362488: Evaluation of Ankle Propriocement and Stability
Official title: Evaluation of Ankle Propriocement and Stability in Patients Affected by Traumatic Lateral Ankle Instability Before and After External Ankle Ligament Recontruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprains
Instability, Joint
Keywords: sprain
Brostrom
ankle instability
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: DIAGNOSTIC

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Delos (computerized oscillating platform)
timeFrame: End of the study, 18 month from the beginning (04 August 2020)
measure: Foot & Ankle Ability Measure (FAAM) questionnaire.
timeFrame: End of the study, 18 month from the beginning (04 August 2020)
measure: American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
timeFrame: End of the study, 18 month from the beginning (04 August 2020)
measure: Short Form Health Survey - 12 questionnaire
timeFrame: End of the study, 18 month from the beginning (04 August 2020)
measure: modified Star Excursional Balance Test (mSEBT) functional test
timeFrame: End of the study, 18 month from the beginning (04 August 2020)
measure: Short Physical Performance Battery functional test
timeFrame: End of the study, 18 month from the beginning (04 August 2020)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
state: BO
Study officials:
affiliation: Rizzoli Orthopaedic Istitute, Bologna
name: Massimiliano Mosca
role: PRINCIPAL_INVESTIGATOR
References: