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

NCT ID: NCT05163418

Last Updated: 2025-07-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-08

Study Completion Date

2024-02-02

Brief Summary

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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

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Conditions

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Flat Feet High Arched Foot

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flat feet

People with flat feet according to foot posture index (validated by clinical assessment)

Group Type EXPERIMENTAL

Foot orthoses for high arches feet

Intervention Type DEVICE

Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.

High arches feet

People with high arches feet according to foot posture index (validated by clinical assessment)

Group Type EXPERIMENTAL

Foot orthosis for flat feet

Intervention Type DEVICE

Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.

Normal arches feet (control group)

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cryos Technologies Inc.

UNKNOWN

Sponsor Role collaborator

Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

TOPMED

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edith Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

TOPMED

Locations

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TOPMED

Québec, Quebec, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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RD-19-0241_CrA_Valg

Identifier Type: -

Identifier Source: org_study_id

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