Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
Primary Purpose
Flat Feet, High Arched Foot
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Foot orthosis for flat feet
Foot orthoses for high arches feet
Sponsored by
About this trial
This is an interventional treatment trial for Flat Feet
Eligibility Criteria
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.
Sites / Locations
- TOPMED
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Flat feet
High arches feet
Normal arches feet (control group)
Arm Description
People with flat feet according to foot posture index (validated by clinical assessment)
People with high arches feet according to foot posture index (validated by clinical assessment)
Control group
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05163418
First Posted
December 15, 2021
Last Updated
March 2, 2023
Sponsor
TOPMED
Collaborators
Cryos Technologies Inc., Natural Sciences and Engineering Research Council, Canada
1. Study Identification
Unique Protocol Identification Number
NCT05163418
Brief Title
Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
Official Title
Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TOPMED
Collaborators
Cryos Technologies Inc., Natural Sciences and Engineering Research Council, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flat Feet, High Arched Foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flat feet
Arm Type
Experimental
Arm Description
People with flat feet according to foot posture index (validated by clinical assessment)
Arm Title
High arches feet
Arm Type
Experimental
Arm Description
People with high arches feet according to foot posture index (validated by clinical assessment)
Arm Title
Normal arches feet (control group)
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Device
Intervention Name(s)
Foot orthosis for flat feet
Intervention Description
Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.
Intervention Type
Device
Intervention Name(s)
Foot orthoses for high arches feet
Intervention Description
Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.
Primary Outcome Measure Information:
Title
Change from baseline in body's postural symmetry index at 2 months
Description
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.
Time Frame
Baseline and 2 months
Title
Change from baseline in body's postural symmetry index at 6 months
Description
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.
Time Frame
Baseline and 6 months
Title
Change from baseline in body's postural symmetry index at 12 months
Description
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.
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Change from baseline in flexion-extension angles of lower body joints during gait at 2 months
Description
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.
Time Frame
Baseline and 2 months
Title
Change from baseline in flexion-extension angles of lower body joints during gait at 6 months
Description
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.
Time Frame
Baseline and 6 months
Title
Change from baseline in flexion-extension angles of lower body joints during gait at 12 months
Description
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.
Time Frame
Baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edith Martin, PhD
Organizational Affiliation
TOPMED
Official's Role
Principal Investigator
Facility Information:
Facility Name
TOPMED
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S1C1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
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