Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to validate a new non-invasive clinical imaging system to evaluate the efficacy of plantar orthotics and to assess the biomechanical efficiency of plantar orthotics for people with flat or high arch feet. The Cryovizion system should detect changes in participants' posture with an accuracy of 95%, while orthotics should improve the body's postural symmetry index.

Official Title
-----------------
Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System

Conditions
-----------------
Flat Feet, High Arched Foot

Intervention / Treatment
-----------------
* Device: Foot orthosis for flat feet
* Device: Foot orthoses for high arches feet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI<30 No pain No musculoskeletal disorders No balance disorders No pathologies linked to the central nervous system No use of drugs affecting the balance Exclusion Criteria: People with foot pathology other than the arch; People with diabetes ; People with severe obesity ; People wearing high heel shoes regularly ; People with degenerative disease ; People with neuromuscular pathology ; People with a circulatory disorder ; People who have had major lower body surgery; Inability to walk 30 minutes continuously.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flat feet<br>People with flat feet according to foot posture index (validated by clinical assessment) | Device: Foot orthoses for high arches feet<br>* Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.<br>|
| Experimental: High arches feet<br>People with high arches feet according to foot posture index (validated by clinical assessment) | Device: Foot orthosis for flat feet<br>* Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.<br>|
| No Intervention: Normal arches feet (control group)<br>Control group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body's postural symmetry index at 2 months | Change in body's postural symmetry index at 2 months after the beginning of the intervention. This index is calculated based on the Cryovision topographic color imaging system. | Baseline and 2 months | 
| Change from baseline in body's postural symmetry index at 6 months | Change in body's postural symmetry index at 6 months after the beginning of the intervention. This index is calculated based on the Cryovision topographic color imaging system. | Baseline and 6 months | 
| Change from baseline in body's postural symmetry index at 12 months | Change in body's postural symmetry index at 12 months after the beginning of the intervention. This index is calculated based on the Cryovision topographic color imaging system. | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in flexion-extension angles of lower body joints during gait at 2 months | Change in anteroposterior range of motion of the ankle, knee and hip joints when walking measured with a Vicon motion capture system at 2 months. | Baseline and 2 months | 
| Change from baseline in flexion-extension angles of lower body joints during gait at 6 months | Change in anteroposterior range of motion of the ankle, knee and hip joints when walking measured with a Vicon motion capture system at 6 months. | Baseline and 6 months | 
| Change from baseline in flexion-extension angles of lower body joints during gait at 12 months | Change in anteroposterior range of motion of the ankle, knee and hip joints when walking measured with a Vicon motion capture system at 12 months. | Baseline and 12 months |