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Evaluation of Ankle Propriocement and Stability (ANKLE-INT)

Primary Purpose

Ankle Sprains, Instability, Joint

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Preoperative evaluation
Postoperative evaluation
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
February 8, 2019
Last Updated
August 23, 2023
Sponsor
Istituto Ortopedico Rizzoli
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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
End of the study, 18 month from the beginning (04 August 2020)
Title
Foot & Ankle Ability Measure (FAAM) questionnaire.
Description
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.
Time Frame
End of the study, 18 month from the beginning (04 August 2020)
Title
American Orthopaedic Foot & Ankle score (AOFAs) questionnaire
Description
AOFAs: values from 0 to 100 dependent on limitations in performing activities
Time Frame
End of the study, 18 month from the beginning (04 August 2020)
Title
Short Form Health Survey - 12 questionnaire
Description
SF12: personal assessment of one's state of health using multiple-answer questions with different values for each question.
Time Frame
End of the study, 18 month from the beginning (04 August 2020)
Title
modified Star Excursional Balance Test (mSEBT) functional test
Description
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
Time Frame
End of the study, 18 month from the beginning (04 August 2020)
Title
Short Physical Performance Battery functional test
Description
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.
Time Frame
End of the study, 18 month from the beginning (04 August 2020)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimiliano Mosca
Organizational Affiliation
Rizzoli Orthopaedic Istitute, Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rizzoli Orthopaedic Institute
City
Bologna
State/Province
BO
ZIP/Postal Code
40126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Ankle Propriocement and Stability

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