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Clinical Trials/NCT06090357
NCT06090357
Recruiting
N/A

Biomechanical Functional Evaluation of Plantar Pressures After Foot and Ankle Surgeries

Istituto Ortopedico Rizzoli1 site in 1 country100 target enrollmentJuly 10, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Plantar Pressure
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
100
Locations
1
Primary Endpoint
Visual Analogue Scale
Status
Recruiting
Last Updated
9 months ago

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
July 10, 2021
End Date
May 31, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Visual Analogue Scale

Time Frame: 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).

Study Sites (1)

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