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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Flat Feet; High Arched Foot
• Intervention / Treatment: Device: Foot orthoses for high arches feet; Device: Foot orthosis for flat feet

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yoann Dessery, PhD; Phone Number: 4187801301; Email: ydessery@topmed.ca
• Study Contact Backup: Name: Edith Martin, PhD; Phone Number: 4187801301; Email: emartin@topmed.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1S1C1
      • TOPMED

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: TOPMED
• Collaborators: Natural Sciences and Engineering Research Council, Canada; Cryos Technologies Inc.
• Investigators: Principal Investigator: Edith Martin, PhD, TOPMED

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Anticipated): June 15, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot; Talipes Cavus
• Other Study ID Numbers: RD-19-0241_CrA_Valg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No