NCT05163418

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

Completed NA Results posted Last updated 30 July 2025

What this trial tests

NA trial testing Foot orthosis for flat feet in Flat Feet in 65 participants. Completed in 2 February 2024.

Timeline

8 October 2021

Primary endpoint
2 February 2024

2 February 2024

Quick facts

Lead sponsor	TOPMED
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	8 October 2021
Primary completion	2 February 2024
Estimated completion	2 February 2024
Sites	1 location across Canada

Drugs / interventions tested

• Foot orthosis for flat feet
• Foot orthoses for high arches feet

Conditions studied

• Flat Feet — all drugs for Flat Feet →
• High Arched Foot — all drugs for High Arched Foot →

Sponsor

TOPMED

Who can join

Adults 18 to 50, any sex, with Flat Feet or High Arched Foot. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months Primary · Baseline and 2 months

Change in body's postural symmetry index(SSIM gray) at 2 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.

Group	Value	95% CI
Experimental: Flat Feet	-0.031	± 0.054
Experimental: High Arches Feet	0.010	± 0.061

Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months Primary · Baseline and 6 months

Change in body's postural symmetry index(SSIM gray) at 6 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.

Group	Value	95% CI
Experimental: Flat Feet	0.020	± 0.070
Experimental: High Arches Feet	-0.016	± 0.076

Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months Primary · Baseline and 12 months

Change in body's postural symmetry index(SSIM gray) at 12 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.

Group	Value	95% CI
Experimental: Flat Feet	0.041	± 0.079
Experimental: High Arches Feet	0.006	± 0.057

Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months Primary · Change between directly after 2 months of intervention and baseline values

Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 2 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.

Hip asymmetry

Group	Value	95% CI
Experimental: Flat Feet	0.04	± 0.97
Experimental: High Arches Feet	0.41	± 0.33

Knee asymmetry

Group	Value	95% CI
Experimental: Flat Feet	0.14	± 1.67
Experimental: High Arches Feet	0.33	± 0.81

Ankle asymmetry

Group	Value	95% CI
Experimental: Flat Feet	0.20	± 1.72
Experimental: High Arches Feet	0.28	± 1.85

Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months Primary · Change between directly after 6 months of intervention and baseline values

Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 6 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.

Hip asymmetry

Group	Value	95% CI
Experimental: Flat Feet	0.09	± 0.91
Experimental: High Arches Feet	0.43	± 0.51

Knee asymmetry

Group	Value	95% CI
Experimental: Flat Feet	0.27	± 1.68
Experimental: High Arches Feet	0.37	± 1.59

Ankle asymmetry

Group	Value	95% CI
Experimental: Flat Feet	0.79	± 1.81
Experimental: High Arches Feet	0.18	± 1.00

Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months Primary · Change between directly after 12 months of intervention and baseline values

Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 12 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.

Hip asymmetry

Group	Value	95% CI
Experimental: Flat Feet	-0.02	± 1.10
Experimental: High Arches Feet	0.28	± 0.60

Knee asymmetry

Group	Value	95% CI
Experimental: Flat Feet	0.10	± 0.94
Experimental: High Arches Feet	0.47	± 1.05

Ankle asymmetry

Group	Value	95% CI
Experimental: Flat Feet	-0.14	± 1.16
Experimental: High Arches Feet	0.92	± 1.87

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from baseline to 12 months visit for the groups with treatment(flat and high arches feet). No follow-up was done with the normal feet group therefore adverse event data was only collected for baseline visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Flat Feet

Serious: 0/34 (0%)

Deaths: 0/34

High Arches Feet

Serious: 0/11 (0%)

Deaths: 0/11

Normal Arches Feet (Control Group)

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	Flat Feet	High Arches Feet	Normal Arches Feet (Contro…
Foot pain	Musculoskeletal and connective tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT05163418 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.