Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
Phase: NA
Conditions: Flat Feet, High Arched Foot
Sponsor: TOPMED

 
Validation protocol of foot orthoses for abnormal plantar arch using 
a new non-invasive clinical imaging system 
 
 
 
 
 
 
 
 
 
Presented to the Véritas IRB Research Ethics Committee 
 
 
 
 
 
 
TOPMED  
 
 
 Version 02 
Approved in french on September 23rd 2022 
Translated on June 26th 2025 
NCT05163418 
 
 

 
 
 
SCHEDULED START AND END DATES 
September 2021 to June 2023 
 
RESEARCH PROJECT DESCRIPTION 
 
Issues 
Plantar arch deviations, flat feet or hollow feet, are common problems that lead to loss of stability, poor 
posture and gait, and are thus at the root of many ailments and injuries. Cryos Technologies Inc. is a Quebec-
based company specializing in the development of custom-made 3D foot orthotics, as well as equipment to 
promote the efficient production and fitting of these orthotics. 
State of knowledge and project relevance  
Made up of 26 bones and supporting up to 70kg/cm2, the foot is the foundation of the body. It holds the 
whole in balance thanks to just three points of support. Any misalignment, however minor, has 
repercussions for the whole body. The abnormal tension caused by this imbalance is amplified from one 
joint to the next. Ankles, knees and hips, as well as muscular chains, can be disrupted, resulting in a change 
in the person's overall posture and potentially causing pain. 
Foot orthotics, regardless of how they are produced (molded or 3D printed), are the standard in the 
treatment of foot pain and pathologies, including hollow feet and flat feet. A foot orthosis is a custom-made 
orthopedic insole that fits into a shoe and is applied to all or part of the plantar surface. By restoring balance 
between the foot's three support points, the foot orthosis helps stabilize joints and rebalance muscular 
tension. 
Cryos' unique process, from digital impression taking to software design to orthotic printing, offers the 
many advantages of digital methods over conventional manual methods: speed of execution, elimination of 
consumables (space saving, no waste production, no water use), reproducibility, precision and reliability of 
volumetrics. The Cryos global system, which combines the Cryovizion posture analysis system with the 
production of Cryos foot orthotics, is already in use in several podiatry establishments, but has never been 
formally validated in terms of the effect of manufactured orthotics and postural analysis. 
Research objectives 
The aim of this project will be to validate a new non-invasive clinical imaging system for assessing the 
effectiveness of foot orthoses and to evaluate the biomechanical effectiveness of foot orthoses for flat-footed 
and hollow-footed people. The cryovizion system should detect changes in participants' posture with 95% 
accuracy, while the orthoses should improve the body's postural symmetry index. 
Financing 
The project was funded by NSERC's Strengthening College and Community Innovation program in 
partnership with Cryos Technologies Inc. 
 
Partner company 
Cryos Technologies Inc. 
Philippe Légaré, Technical Manager 

 
385 rue de Salaberry, Joliette, Qc, J6E 4G4 
450-753-3704 
plegare@cryos.com 
 
RESEARCH METHODOLOGY 
Research location 
On TOPMED's premises at Collège Mérici, 755 Grande-Allée Ouest, Quebec City. 
 
Type of test 
Repeated measurements on a single group with pre-tests and follow-up at 2, 6 and 12 months. 
 
Measurement, assessment and data collection tools  
Assessment : 
An orthotist will take measurements and photos of the participants' feet, and assess their range of motion. 
Scanning : 
A Cryoscan 3D optical scanner (https://www.cryos.com/en/professionals/cryoscan-3d/) will be used to 
generate digital impressions of the participants' feet. These prints will be used to extract statistical data on 
morphological proportions and to model custom orthotics. This measurement system is non-invasive and 
harmless to health. 
Analysis of walking pattern : 
The Vicon motion capture system will provide more precise data as participants walk. The system consists 
of 8 infrared cameras that triangulate the exact spatial position of the sensors, which will be strategically 
positioned at anatomical landmarks on the participants' lower limbs. (https://www.vicon.com/about-
us/what-is-motion-capture/). This validation system is non-invasive and harmless to health. 
Load 
distribution between 
the 
legs 
will be 
analyzed using 
two 
AMTI force 
platforms 
(https://amti.biz/AMTIpibrowser.aspx). 
Assessment of body symmetry will be performed using Cryovizion©, a non-invasive medical imaging tool 
(https://www.cryos.com/produits/cryovizion/). The Cryovizion imaging system uses LED light technology 
combined with a soft-tissue reflection enhancement filter following primary imaging, which generates a 
secondary image where color tones on skin surfaces vary according to distance from the camera. During 
image capture, subjects are instructed to stand up straight, wearing their underwear. Images are acquired 
from the front, side and back, from head to toe. 
Questionnaires : 
Subjective questionnaires and a logbook will be completed by participants to validate comfort when 
wearing the orthosis, and to target the extent to which and how pain is reduced. 
 
Estimated duration of participants' activities 
People with normal arches 

 
1st session :  
2h 
People with flat or hollow feet 
1st session :  
1h to 1h30 
2nd session :  
2h 
12-month trial phase 
Telephone call (2 weeks): 5 minutes 
3rd session (2months) : 1h30 to 2h 
4th session (6 months) : 1h30 to 2h 
5th session (12 months) : 1h30 to 2h 
 
PARTICIPATION OF LIVE HUMAN, ANIMAL OR MATERIAL PARTICIPANTS  
80 human participants aged between 18 and 50 will be recruited. Participants will be divided into three 
distinct groups: 20 participants with feet having a normal arch (control group), 30 participants with flat 
feet and 30 participants with hollow feet. The first session will be devoted to taking anthropometric 
measurements of the limb to be instrumented. The second session will be used to try on and adjust the 
orthoses, and to take pre-test biomechanical data. The following three sessions will be follow-up visits, and 
will consist in taking biomechanical data 
Inclusion criteria   
- 
Common 
o Between the ages of 18 and 50 
o BMI<30 
o No pain 
o No musculoskeletal problems 
o No balance problems 
o No central nervous system pathologies 
o No drugs that affect balance 
- 
Participants with flat feet 
o Flat feet according to foot posture index 6 (FPI6, confirmed by clinical assessment) 
- 
Participants with hollow feet 
o Hollow feet according to foot posture index 6 (FPI6, confirmed by clinical assessment) 
Exclusion criteria 
- 
Common 
o People with foot pathologies other than arch pathologies; 
o Diabetics ; 
o Severely obese people ; 
o People who regularly wear high-heeled shoes; 
o People with degenerative diseases ; 
o People with neuromuscular pathologies ; 
o People with circulatory disorders ; 
o People who have had major lower-body surgery. 
o Inability to walk for 30 minutes continuously. 

 
 
SCIENTIFIC JUSTIFICATION FOR USING LIVE SUBJECTS 
The participation of human participants representative of the clientele is essential for validation of the 
imaging system and evaluation of the foot orthoses. The acquisition of comparison data with a validated 
system will enable us to validate the biomechanical effects of the orthoses observed thanks to the 
Cryovizion system, and follow-up over several months will also enable us to determine the biomechanical 
effect of the orthoses over the medium term. 
 
RECRUITMENT 
Postings will be made in private orthotics and prosthetics laboratories, in traditional media, on social media 
and on the Collège Mérici bulletin boards. Candidates can express their interest by calling or writing to 
TOPMED. A member of the project team will be able to answer questions, assess eligibility, send 
documentation and/or arrange a telephone appointment at a later date. 
 
RISKS AND DRAWBACKS, AND PROPOSED MITIGATION MEASURES  
An allergic skin reaction (redness) due to wearing the brace is a potential injury. The participant should 
stop wearing the brace, if necessary.  
Ecchymosis or phlyctena may appear at certain pressure points due to poor orthosis fit or incorrect 
placement. A follow-up telephone call will be made after 2 weeks' wear to ensure that the participant is 
comfortable with the fit. If any subsequent discomfort is experienced, the participant should stop wearing 
the brace and contact the orthotist. 
No potential damage when capturing data with the Cryovizion system. 
 
ADVANTAGES AND BENEFITS  
The advantage of their participation is that it will provide empirical data on the system and on orthotic 
wear. This is an advantage for Cryos Technologies Inc. 
 
FREE AND INFORMED CONSENT  
The consent form will be provided and explained to them when they make the appointment for the 1st 
session. A period of two (2) weeks, or more if necessary, will be allowed to give the participant time to read 
and reflect. At the 1st session, a paper consent form will be handed out and explained point by point by the 
orthotist, before the participants decide whether or not to sign it. 
 
CONFIDENTIALITY AND PROTECTION OF PERSONAL INFORMATION  
The information collected in the questionnaires, the video captures by the Vicon system, the photos and the 
biomechanical data collected are confidential and will only be used in the context of this research project, 
unless otherwise agreed by the participant. All data, notes and computer recordings (including the 
Cryovizion system, photos, Vicon motion capture and foot scans) are encrypted on servers. Unless required 
by law, no information that could directly or indirectly reveal their identity will be released or published 
without their prior explicit consent. 

 
The data will be kept for a period of five (5) years, then anonymized in a database for retention for a period 
of ten (10) years for the purpose of reference statistics.  
Surnames, first names, telephone numbers and/or e-mail addresses will be collected for communication 
purposes exclusively related to this project. Participants will not be identified by name in trial 
documentation. They will be assigned a number, relative to the order of their recruitment, which will be 
used to reference the data collected. The list of codes linking a name to a research file will be kept in the 
office of the responsible researcher, in a locked filing cabinet at TOPMED at Mérici Collégial Privé, 755 
Grande Allée Ouest, Québec, Qc, G1S 1C1.  
Any scientific publication resulting from this research project will present statistical data only, and under 
no circumstances will the names of the participants be published or divulged to anyone. 
 
CONTINUOUS EXAMINATION 
Should any inconvenience arise following the completion of the prototype validation test, participants will 
be promptly notified. 
 
DISSEMINATING RESULTS 
No disclosure to patients will be made following the trials. 
Results will not be published. 
 
COMPENSATION  
No remuneration will be paid. If necessary, a parking sticker will be provided to participants during their 
sessions. Compensation of $25 per participant in the control group. A compensation of $200 per participant 
for the hollow/flat feet group will be given for their full participation in the validation protocol. This amount 
will be distributed over the last four sessions ($30 at the 2nd session, $40 at the 3rd session, $50 at the 4th 
session and $80 at the 5th session). In addition, participants in the hollow/flat foot group will be able to 
keep their foot orthotics if they complete all sessions. 
 
RESPONSIBILITY 
The legal rights of each participant will be maintained. 
 
PROTOCOL SEQUENCE  
 
Display 
 
Postings in private orthotics and prosthetics labs, traditional and social media, on our 
website and on Mérici College bulletin boards 
0241_CrA_Recrutement_Affichage_Normaux_V2 
0241_CrA_Recrutement_Affichage_PlatsCreux_V4 
Admission  
 
Validation by e-mail or telephone. 

 
 
 
0241_CrA_Recrutement_Formulaire_Admission_VF 
Appointment: 2 weeks (or more if necessary) between delivery of consent form and first 
session. 
 
Sending documents : 
▪ 
Hygiene_clinical measures 
▪ 
Self-evaluation_visitor form 
Sending documents and explanations : 
▪ 
0241_CrA_Rencontre1_Consent_form_VF 
COVID call 
 
A self-assessment confirmation will be issued 24 hours before each session. 
 
 

 
Sessions schedule 
 
The following abbreviations stand for the different conditions under which measurements are 
taken: PN = barefoot; SO = shod without orthotics; AO = shod with orthotics. 
 
 
Control 
flat/hollow 
documentation 
Session 1 
FPI6 
Joint assessment 
Cryovizion PN+ SO 
Vicon PN+ SO 
FPI6 
Joint assessment 
Cryoscan3D 
(impression) 
Cryoscan2D 
Cryovizion PN 
0241_CrA_Rencontre1_Consent_form_VF 
Compensation $25 for inspection only 
Session 2 
(Day 0) 
No session for this 
group 
OP delivery 
Cryovizion SO+ 
AO 
Vicon SO+ AO 
Compensation $30 
12-month 
trial phase 
No session for this 
group 
Telephone 
follow-up after 2 
weeks 
0241_CrA_Rencontre2_Journal_VF 
Session 3 (2 
months) 
 
No session for this 
group 
 
Cryovizion SO+ 
AO+ PN 
Vicon SO+ AO+ 
PN 
Compensation $40 
0241_CrA_QuestionnaireSession345_VF 
0241_CrA_Rencontre2_Journal_VF (Verification) 
Session 4 (6 
months) 
No session for this 
group 
Cryovizion SO + 
AO + PN 
Vicon SO + AO + 
PN 
Compensation $50 
0241_CrA_Questionnaire_Rencontre345_VF 
0241_CrA_Rencontre2_Journal_VF (Verification) 
Session 5 (12 
months) 
 
No session for this 
group 
 
Cryovizion SO + 
AO + PN 
Vicon SO + AO + 
PN 
Compensation $80 
0241_CrA_QuestionnaireSession345_VF 
0241_CrA_Rencontre2_Journal_VF (Verification) 
 

 
The orthoses are modeled and manufactured by 3D SLS printing for plat/creux 
participants only, with data from encounter 1 by partner company Cryos. They are then sent to 
Topmed. 
 
Data processing 
 
Biomechanical data processing. 
Cryovizion data processing 
 
Data recording: Questionnaires.