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Evaluation of Ankle Propriocement and Stability (ANKLE-INT)

I

Istituto Ortopedico Rizzoli

Status

Completed

Conditions

Ankle Sprains
Instability, Joint

Treatments

Procedure: Preoperative evaluation
Procedure: Postoperative evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT04362488
558/2018/Oss/IOR

Details and patient eligibility

About

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

Full 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)

Enrollment

23 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

Patients with chronic post-traumatic lateral ankle instability
Experimental group
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)
Treatment:
Procedure: Preoperative evaluation
Procedure: Postoperative evaluation

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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