Flat FeetNCT05163418

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

A study testing Foot orthosis for flat feet and Foot orthoses for high arches feet in people with Flat Feet and High Arched Foot, run by TOPMED at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Flat Feet, High Arched Foot
What is being tested?: Foot orthosis for flat feet and Foot orthoses for high arches feet
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteCanada
Study dates: 8 Oct 2021to 2 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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 ;

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People with a circulatory disorder ;
People who have had major lower body surgery;
Inability to walk 30 minutes continuously.

Trial locations and contacts

1 site in 1 country.

Canada1 site

TOPMED
Québec, Quebec, G1S1C1

Other trials in Canada

About this study

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.

Conditions: Flat Feet, High Arched Foot
Being tested: Foot orthosis for flat feet, Foot orthoses for high arches feet
Medical subject headings: Flatfoot, Talipes Cavus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Foot orthosis for flat feetDevice
Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.
Foot orthoses for high arches feetDevice
Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.

Study groups in NCT05163418
Study group	Role	What they receive
Flat feet	Experimental	People with flat feet according to foot posture index (validated by clinical assessment) Receives: Device: Foot orthoses for high arches feet
High arches feet	Experimental	People with high arches feet according to foot posture index (validated by clinical assessment) Receives: Device: Foot orthosis for flat feet
Normal arches feet (control group)	No intervention	Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months
Change in body's postural symmetry index(SSIM gray) at 2 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.
Measured: Baseline and 2 months
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months
Change in body's postural symmetry index(SSIM gray) at 6 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.
Measured: Baseline and 6 months
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months
Change in body's postural symmetry index(SSIM gray) at 12 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.
Measured: Baseline and 12 months
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months
Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 2 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.
Measured: Change between directly after 2 months of intervention and baseline values
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months
Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 6 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.
Measured: Change between directly after 6 months of intervention and baseline values
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months
Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 12 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.
Measured: Change between directly after 12 months of intervention and baseline values

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 20212 Feb 2024

First posted20 Dec 2021
Study start8 Oct 2021
Primary completion2 Feb 2024
Study completion2 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Flat FeetStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05163418
Sponsor's protocol ID: RD-19-0241_CrA_Valg
Status last verified: Jul 2025
First submitted: 15 Dec 2021
Last updated: 30 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Flat Feet trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
ClinicalTrials.gov ID: NCT05163418
Acronym / sponsor ID: RD-19-0241_CrA_Valg
Conditions: Flat Feet, High Arched Foot
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: TOPMEDUniversity, hospital or other
Collaborators: Cryos Technologies Inc., Natural Sciences and Engineering Research Council, Canada
Study start: 8 Oct 2021 (actual)
Primary completion: 2 Feb 2024 (actual)
Study completion: 2 Feb 2024 (actual)
First posted: 20 Dec 2021 (actual)
Results: Posted 30 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Flat feet	Experimental	Device: Foot orthoses for high arches feetPeople with flat feet according to foot posture index (validated by clinical assessment)
High arches feet	Experimental	Device: Foot orthosis for flat feetPeople with high arches feet according to foot posture index (validated by clinical assessment)
Normal arches feet (control group)	No intervention	–Control group

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

BMI<30
No pain
No musculoskeletal disorders
No balance disorders
No pathologies linked to the central nervous system

Key exclusion criteria (9 listed)

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 ;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Foot orthosis for flat feetPlantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.	Device	High arches feet
Foot orthoses for high arches feetPlantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.	Device	Flat feet

Primary outcome

Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months
Time frame: Baseline and 2 months
Change in body's postural symmetry index(SSIM gray) at 2 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months
Time frame: Baseline and 6 months
Change in body's postural symmetry index(SSIM gray) at 6 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months
Time frame: Baseline and 12 months
Change in body's postural symmetry index(SSIM gray) at 12 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months
Time frame: Change between directly after 2 months of intervention and baseline values
Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 2 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months
Time frame: Change between directly after 6 months of intervention and baseline values
Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 6 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months
Time frame: Change between directly after 12 months of intervention and baseline values
Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 12 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.

Results and safety

Results posted to the registry on 30 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Flat Feet	34	23
High Arches Feet	11	7
Normal Arches Feet (Control Group)	20	20

Primary outcome: Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months

Time frame: Baseline and 2 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Experimental: Flat Feet n = 22	Experimental: High Arches Feet n = 7	Normal Arches Feet (Control Group) n = 0
Value	-0.031 (0.054)	0.010 (0.061)	–

Population analysed: The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.

Primary outcome: Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Experimental: Flat Feet n = 22	Experimental: High Arches Feet n = 7	Normal Arches Feet (Control Group) n = 0
Value	0.020 (0.070)	-0.016 (0.076)	–

Population analysed: The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.

Primary outcome: Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months

Time frame: Baseline and 12 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Experimental: Flat Feet n = 22	Experimental: High Arches Feet n = 7	Normal Arches Feet (Control Group) n = 0
Value	0.041 (0.079)	0.006 (0.057)	–

Population analysed: The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.

Primary outcome: Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months

Time frame: Change between directly after 2 months of intervention and baseline values. Mean (Standard Deviation). Unit: degrees

Measure	Experimental: Flat Feet n = 23	Experimental: High Arches Feet n = 7	Normal Arches Feet (Control Group) n = 0
Hip asymmetry	0.04 (0.97)	0.41 (0.33)	–
Knee asymmetry	0.14 (1.67)	0.33 (0.81)	–
Ankle asymmetry	0.20 (1.72)	0.28 (1.85)	–

Population analysed: Participants who completed the overall study.

Adverse events

Time frame: Adverse event data was collected from baseline to 12 months visit for the groups with treatment(flat and high arches feet). No follow-up was done with the normal feet group therefore adverse event data was only collected for baseline visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flat Feet	0 of 34 (0%)	4 of 34 (11.8%)	0 of 34
High Arches Feet	0 of 11 (0%)	4 of 11 (36.4%)	0 of 11
Normal Arches Feet (Control Group)	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): Target number of participants needed to achieve target power was not reached for all groups. Drop outs were not evenly distributed in between groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Edith Martin, PhD principal investigator

TOPMED

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Foot orthosis for flat feet and Foot orthoses for high arches feet in people with Flat Feet and High Arched Foot, run by TOPMED at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months (time frame: Baseline and 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05163418.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.