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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
TOPMED
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flat Feet

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
December 15, 2021
Last Updated
March 2, 2023
Sponsor
TOPMED
Collaborators
Cryos Technologies Inc., Natural Sciences and Engineering Research Council, Canada
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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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