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

Not Applicable

Active, not recruiting

• Conditions: Flat Feet; High Arched Foot
• Interventions: Device: Foot orthosis for flat feet; Device: Foot orthoses for high arches feet

• Registration Number: NCT05163418
• Lead Sponsor: TOPMED

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-08
• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2021-12-20
• Primary Completion: 2024-03-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High arches feet	Foot orthosis for flat feet	People with high arches feet according to foot posture index (validated by clinical assessment)
Flat feet	Foot orthoses for high arches feet	People with flat feet according to foot posture index (validated by clinical assessment)

Primary Outcome Measures

Name	Time	Method
Change from baseline in body's postural symmetry index at 2 months	Baseline and 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.
Change from baseline in body's postural symmetry index at 12 months	Baseline and 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.
Change from baseline in body's postural symmetry index at 6 months	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in flexion-extension angles of lower body joints during gait at 2 months	Baseline and 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.
Change from baseline in flexion-extension angles of lower body joints during gait at 6 months	Baseline and 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.
Change from baseline in flexion-extension angles of lower body joints during gait at 12 months	Baseline and 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.

Trial Locations

Locations (1)

TOPMED; 🇨🇦 Québec, Quebec, Canada