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

TOPMED

Status: Completed

Conditions: High Arched Foot; Flat Feet

Treatments: Device: Foot orthoses for high arches feet; Device: Foot orthosis for flat feet

Study type: Interventional

Funder types: Other

Identifiers

NCT05163418

RD-19-0241_CrA_Valg

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

Flat feet

Experimental group

Description:

People with flat feet according to foot posture index (validated by clinical assessment)

Treatment:

Device: Foot orthoses for high arches feet

High arches feet

Experimental group

Description:

People with high arches feet according to foot posture index (validated by clinical assessment)

Treatment:

Device: Foot orthosis for flat feet

Normal arches feet (control group)

No Intervention group

Description:

Control group