Evaluation of Ankle Propriocement and Stability

Ankle Sprains Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362488
• Other study ID #: 558/2018/Oss/IOR
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: November 11, 2023

Study information

• Verified date: December 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 11, 2023
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Instability, Joint
• Joint Instability

Intervention

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)
• 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)

Locations

Country	Name	City	State
Italy	Rizzoli Orthopaedic Institute	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	End of the study, 18 month from the beginning (04 August 2020)
Primary	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.	End of the study, 18 month from the beginning (04 August 2020)
Primary	American Orthopaedic Foot & Ankle score (AOFAs) questionnaire	AOFAs: values from 0 to 100 dependent on limitations in performing activities	End of the study, 18 month from the beginning (04 August 2020)
Primary	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.	End of the study, 18 month from the beginning (04 August 2020)
Primary	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	End of the study, 18 month from the beginning (04 August 2020)
Primary	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.	End of the study, 18 month from the beginning (04 August 2020)