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Recruiting Not applicable

Biomechanical Functional Evaluation of Plantar Pressures After Foot and Ankle Surgeries

NCT06090357 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2021-07-10
Last updated
2025-07-18

Condition(s) studied

Plantar Pressure

Investigational drug(s) / intervention(s)

Plantar pressure

Plantar pressure: Biomechanical functional assessments investigate specific variables: gait analysis, stabilometry, kinematics and kinetics of joint movements, activation, and strength of specific muscle groups.

Study summary

The described surgical techniques for the treatment of foot and ankle pathologies are numerous. In order to objectively assess the outcomes of these procedures, evaluation methods are typically used, primarily considering pain symptoms, residual functionality, the correction of any deformities achieved, and radiographic parameters. Conversely, assessments of plantar pressures, as a potential indicator of functional and biomechanical recovery, are still not widely utilized. Biomechanical functional assessments examine specific variables, including gait analysis, stabilometry, kinematics and kinetics of joint movements, and the activation and strength of particular muscle groups. These assessments can be conducted by specialized personnel using dedicated equipment such as a baropodometric platform and inertial sensors.

This study aims to, for the first time in the literature, present the results related to plantar pressures from different surgical treatments of the foot and ankle

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Patients who need to undergo surgical intervention * Patients of both sexes aged between 18-75 years * Patients who have provided their written informed consent to participate in the study * Patients who have expressed their willingness to attend the Institute for the 6-month follow-up Exclusion Criteria: * Patients with severe postural instability * Patients with cognitive deficits

Primary outcome measure(s)

  • Visual Analogue Scale — At baseline (day 0)
    Visual Analogue Scale (VAS) is one of the pain rating scales. It is unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).
  • Visual Analogue Scale — After 6 months
    Visual Analogue Scale (VAS) is one of the pain rating scales. It is unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).

Trial sites (1)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06090357 on ClinicalTrials.gov ↗ ← All trials in Italy