CompletedNot Applicable

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

Canada65 participantsStarted 2021-10-08

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline and 2 months

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

Timeframe: Baseline and 6 months

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Change between directly after 12 months of intervention and baseline values

Trial details

NCT IDNCT05163418

SponsorTOPMED

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-02

Results submitted2025-04-17

View on ClinicalTrials.gov More Flat Feet trials