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

Flat Feet Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05163418
• Other study ID #: RD-19-0241_CrA_Valg
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 8, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: TOPMED
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: July 1, 2024
• Est. primary completion date: March 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flat Feet
• Flatfoot

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	TOPMED	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
TOPMED	Cryos Technologies Inc., Natural Sciences and Engineering Research Council, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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