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Clinical Trials/NCT04362488
NCT04362488
Completed
N/A

Evaluation of Ankle Propriocement and Stability in Patients Affected by Traumatic Lateral Ankle Instability Before and After External Ankle Ligament Recontruction

Istituto Ortopedico Rizzoli1 site in 1 country23 target enrollmentFebruary 4, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ankle Sprains
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
23
Locations
1
Primary Endpoint
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
Status
Completed
Last Updated
2 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
February 4, 2019
End Date
November 11, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

American Orthopaedic Foot & Ankle score (AOFAs) questionnaire

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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.

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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