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

NCT05163418 | Completed Results

• 1 other identifier: RD-19-0241_CrA_Valg
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Flat Feet; High Arched Foot

Outcome Measures

Primary Outcomes (6)

• Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 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.

  Baseline and 2 months

• Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 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.

  Baseline and 6 months

• Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 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.

  Baseline and 12 months

• Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months

  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.

  Change between directly after 2 months of intervention and baseline values

• Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months

  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.

  Change between directly after 6 months of intervention and baseline values

• Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months

  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.

  Change between directly after 12 months of intervention and baseline values

Study Arms (3)

Flat feet

EXPERIMENTAL

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

Device: Foot orthoses for high arches feet

High arches feet

EXPERIMENTAL

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

Device: Foot orthosis for flat feet

Normal arches feet (control group)

NO INTERVENTION

Control group

Interventions

Foot orthosis for flat feet DEVICE

Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.

High arches feet

Foot orthoses for high arches feet DEVICE

Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.

Flat feet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TOPMED: lead
• Cryos Technologies Inc.: collaborator
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

TOPMED

Québec, Quebec, G1S1C1, Canada

Location

MeSH Terms

Conditions

Flatfoot; Talipes Cavus

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Limitations and Caveats

Target number of participants needed to achieve target power was not reached for all groups. Drop outs were not evenly distributed in between groups.

Results Point of Contact

• Title: Edith Martin
• Organization: Topmed

emartin@topmed.ca

418 683-2104

Study Officials

• Edith Martin, PhD

  TOPMED

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 20, 2021
• Study Start: October 8, 2021
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)