Evaluation of Ankle Propriocement and Stability - Clinical Trial for Ankle Sprains | NCT04362488

Back to results

Primary Purpose

Status

Active

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Preoperative evaluation

Postoperative evaluation

About this trial

This is an interventional diagnostic trial for Ankle Sprains focused on measuring sprain, Brostrom, ankle instability

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rizzoli Orthopaedic Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with chronic post-traumatic lateral ankle instability

Arm Description

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)

Outcomes

Primary Outcome Measures

Delos (computerized oscillating platform)

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.

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.

American Orthopaedic Foot & Ankle score (AOFAs) questionnaire

AOFAs: values from 0 to 100 dependent on limitations in performing activities

Short Form Health Survey - 12 questionnaire

SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.

modified Star Excursional Balance Test (mSEBT) functional test

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04362488

First Posted

February 8, 2019

Last Updated

August 23, 2023

Sponsor

Istituto Ortopedico Rizzoli

1. Study Identification

Unique Protocol Identification Number

NCT04362488

Brief Title

Evaluation of Ankle Propriocement and Stability

Acronym

ANKLE-INT

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 4, 2019 (Actual)

Primary Completion Date

February 1, 2022 (Actual)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Sprains, Instability, Joint

Keywords

sprain, Brostrom, ankle instability

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with chronic post-traumatic lateral ankle instability

Arm Type

Experimental

Arm Description

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)

Intervention Type

Procedure

Intervention Name(s)

Preoperative evaluation

Other Intervention Name(s)

Questionnaires: "FAAM", "AOFAs", "SF12", Instrument: "Delos computerized oscillating platform", Tests: "mSEBT", "SPPB"

Intervention Description

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)

Intervention Type

Procedure

Intervention Name(s)

Postoperative evaluation

Other Intervention Name(s)

Questionnaires: "FAAM", "AOFAs", "SF12", Instrument: "Delos computerized oscillating platform", Tests: "mSEBT", "SPPB"

Intervention Description

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)

Primary Outcome Measure Information:

Title

Delos (computerized oscillating platform)

Description

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.

Time Frame