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Evaluation of Ankle Propriocement and Stability

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04362488
Acronym
ANKLE-INT
Enrollment
23
Registered
2020-04-27
Start date
2019-02-04
Completion date
2023-11-11
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprains, Instability, Joint

Keywords

sprain, Brostrom, ankle instability

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)

Interventions

PROCEDUREPreoperative 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)

PROCEDUREPostoperative 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)

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Delos (computerized oscillating platform)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.
Foot & Ankle Ability Measure (FAAM) questionnaire.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.
American Orthopaedic Foot & Ankle score (AOFAs) questionnaireEnd of the study, 18 month from the beginning (04 August 2020)AOFAs: values from 0 to 100 dependent on limitations in performing activities
Short Form Health Survey - 12 questionnaireEnd 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.
modified Star Excursional Balance Test (mSEBT) functional testEnd 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
Short Physical Performance Battery functional testEnd 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026