Evaluation of Ankle Propriocement and Stability (ANKLE-INT)

December 5, 2023 updated by: Istituto Ortopedico Rizzoli

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

The objective of the study is to evaluate the postural control and proprioception before and after external capsulo-ligament reconstruction for ankle instability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40126
        • Rizzoli Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with chronic post-traumatic lateral ankle instability

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)
Procedure: Preoperative evaluation

Preoperative evaluation using differents clinical evaluation 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)
Other Names:
  • Questionnaires: "FAAM", "AOFAs", "SF12"
  • Instrument: "Delos computerized oscillating platform"
  • Tests: "mSEBT", "SPPB"
Procedure: Postoperative evaluation

Postoperative evaluation at 4 months of follow up after surgery using differents clinical evaluation 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)
Other Names:
  • Questionnaires: "FAAM", "AOFAs", "SF12"
  • Instrument: "Delos computerized oscillating platform"
  • Tests: "mSEBT", "SPPB"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
End of the study, 18 month from the beginning (04 August 2020)
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.
End of the study, 18 month from the beginning (04 August 2020)
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
End of the study, 18 month from the beginning (04 August 2020)
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.
End of the study, 18 month from the beginning (04 August 2020)
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
End of the study, 18 month from the beginning (04 August 2020)
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.
End of the study, 18 month from the beginning (04 August 2020)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Massimiliano Mosca, Rizzoli Orthopaedic Istitute, Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2019

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

November 11, 2023

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 558/2018/Oss/IOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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