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Completed

NCT Number: NCT04362488

Evaluation of Ankle Propriocement and Stability

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

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Key information

Conditions

Ankle Sprains Ankle Injuries Instability, Joint Joint Diseases Joint Instability Leg Injuries Musculoskeletal Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rizzoli Orthopaedic Institute

Bologna, BO, 40126, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative evaluation

Procedure

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"

Postoperative evaluation

Procedure

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"

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: ANKLE-INT

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Apr 27, 2020
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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