Flat Feet Clinical Trial
Official title:
Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
Verified date | May 2024 |
Source | TOPMED |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | TOPMED | Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
TOPMED | Cryos Technologies Inc., Natural Sciences and Engineering Research Council, Canada |
Canada,
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 |
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