N/A N=65 Treatment

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

Flat Feet · High Arched Foot

Bottom Line

View on ClinicalTrials.gov: NCT05163418 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months — -0.031; 0.010 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Foot orthosis for flat feet (Device); Foot orthoses for high arches feet (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: TOPMED
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months	-0.031; 0.010	—
PRIMARY Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months	0.020; -0.016	—
PRIMARY Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months	0.041; 0.006	—
PRIMARY Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months	0.04; 0.41; 0.14; 0.33; 0.20; 0.28	—
PRIMARY Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months	0.09; 0.43; 0.27; 0.37; 0.79; 0.18	—
PRIMARY Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months	-0.02; 0.28; 0.10; 0.47; -0.14; 0.92	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05163418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.