CompletedNot Applicable

Evaluation of Ankle Propriocement and Stability

Italy23 participantsStarted 2019-02-04

Plain-language summary

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

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Delos (computerized oscillating platform)

Timeframe: End of the study, 18 month from the beginning (04 August 2020)

Foot & Ankle Ability Measure (FAAM) questionnaire.

Timeframe: End of the study, 18 month from the beginning (04 August 2020)

American Orthopaedic Foot & Ankle score (AOFAs) questionnaire

Timeframe: End of the study, 18 month from the beginning (04 August 2020)

Short Form Health Survey - 12 questionnaire

Timeframe: End of the study, 18 month from the beginning (04 August 2020)

modified Star Excursional Balance Test (mSEBT) functional test

Timeframe: End of the study, 18 month from the beginning (04 August 2020)

Short Physical Performance Battery functional test

Timeframe: End of the study, 18 month from the beginning (04 August 2020)

Trial details

NCT IDNCT04362488

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-01

View on ClinicalTrials.gov More Ankle Sprains trials

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Delos (computerized oscillating platform)

Timeframe: End of the study, 18 month from the beginning (04 August 2020)

Foot & Ankle Ability Measure (FAAM) questionnaire.

Timeframe: End of the study, 18 month from the beginning (04 August 2020)

American Orthopaedic Foot & Ankle score (AOFAs) questionnaire

Timeframe: End of the study, 18 month from the beginning (04 August 2020)

Short Form Health Survey - 12 questionnaire

Timeframe: End of the study, 18 month from the beginning (04 August 2020)

modified Star Excursional Balance Test (mSEBT) functional test

Timeframe: End of the study, 18 month from the beginning (04 August 2020)

Short Physical Performance Battery functional test

Timeframe: End of the study, 18 month from the beginning (04 August 2020)