IRB

RESEARCH CONSENT FORM

Title: AI Driven Personalization for Scalable Custom-Fit Footwear

Principal Investigator: Dr. Yi-Xian Qin

  Stony Brook University

  100 Nicolls Rd.

  Stony Brook, NY 11794

  U.S.A.

KEY INFORMATION

1. The information in this form is being used to seek your consent for a research study. Being in the study is voluntary. It is up to you.

2. This research is being done to find out how to develop an effective software tool for footwear fit analysis using a foot scanning mobile application. This study is being done in conjunction with IAMBIC, an AI-driven custom footwear brand. Participation will last up to 25 minutes for Part 1 and 12 weeks (20.6 hours maximum over the 12 week period) for Part 2. 

3. Overview of study procedures for this research study are: 

Part 1: One in-person session with an authorized research person.

1. Complete an intake questionnaire which asks participant-specific demographic information, past and existing foot issues, and footwear history

2. Foot scan (images and 360-degree videos) in sitting and standing positions using the mobile application.

Part 2: One initial in-person biomechanical evaluation followed by several   remote questionnaires and remote walking sessions.

1. Complete an evaluation of your foot (In-person) including the following:

1. 3D Foot scanning using Artec Space Spider handheld scanner in sitting and standing positions

2. Foot plantar pressure measurement using Moticon OpenGo insoles in standing and walking motions

3. Complete weekly timed walking sessions while wearing provided IAMBIC shoes (at home/remotely).

4. Complete virtual questionnaires which should be filled out after each walking session.

(4) Part 2 is OPTIONAL. Participants in Part 2 will consist of a subset of 50 participants    from Part 1. We may contact you to ask you to participate in Part 2 via email     (BoneEngineering@Stonybrook.edu) AFTER you have participated in Part 1. If you    decline to participate, no further emails will be sent to you. You will receive a gift card    at the end of Part 1 and are NOT required to participate in part 2 to receive the gift     card.

 

(5) The most likely risks to you of the research are:

• Discomfort while wearing IAMBIC shoes during the “break in” period (Part 2).

• Feeling uncomfortable while answering questions about foot issues or abnormalities.

See the RISKS AND DISCOMFORTS section of this form for a complete list of possible side effects

(6) The most likely benefits to you are: 

• It is not expected that you will personally benefit from this research. 

• Possible benefits to you and others include the development of a virtual smartphone-based fitting system for custom footwear. This may be available for consumers to use in the future to obtain custom footwear.

4. If you decide not to be in the research, your choices (if any) are: 

As this is not a treatment study, the alternative is to not participate.

You are being asked to be a volunteer in a research study. 

PURPOSE 

The purpose of this study is to develop and test an AI-driven virtual shoe fitting system for custom footwear.

You are eligible for this study if: 

• You are between the ages of 18 and 75.

• You do not have any physical abnormalities or conditions which affect you from walking normally.

• You do not have any physical abnormalities or amputations which cause you to have less than two feet.

• (Part 2 only) You do not have any physical abnormalities or conditions which prevent you from wearing sneakers or other similar footwear. 

• You do not have a unique/identifying birthmark or tattoo on your ankle/foot. (This is to ensure that no participant's identity is put at risk).

• You are not pregnant.

• You have Basic english speaking, reading, and listening skills to understand the consent form.

• You do not have peripheral vascular disease or diabetes mellitus
  
  

• Description of Study:

Most shoes on the market are made in standard sizes that do not accommodate individual differences in foot shape, often leading to discomfort and potential foot health issues. While custom-made shoes can provide a better fit, they are typically expensive ($3,000-$10,000) and not accessible to most people.

The purpose of this study is to develop an AI-driven virtual shoe fitting system that can analyze foot shape and personal footwear preferences for a custom-fit footwear. Using a smartphone-based scanning process, we will collect foot images, as well as foot, and footwear history. A machine learning model will then be trained on this data for custom-fit footwear design and manufacturing.

By participating in this research, you will help advance technology that aims to make custom-fit shoes more accessible and comfortable for a wider population. Your participation will involve a simple foot scan and may include a follow-up evaluation of biomechanics and footwear fit. 

• There will be 500 subjects in the study overall. 500 subjects will participate in Part 1 of this study. 50 of those 500 subjects will be asked to participate in part 2 of this study. A majority of the participants are expected to be a part of the Stony Brook University community.

PROCEDURES 

If you decide to be in this study, your part will involve participation in part 1 and possible participation in part 2: 

Part 1: Foot Scanning and Data Collection (One-Time Visit – 15-25 minutes)

• Consent Process: You will read and sign the consent form before any procedures begin.

• Demographic Questionnaire: You will answer a short questionnaire about your age, gender, foot health, and footwear preferences (5-10 minutes).

• Foot Scanning Using a Smartphone App:

• You will remove your shoes and socks and place your foot on a standard letter-sized piece of paper.

• A researcher will take 3 photos and a short video of each foot both while sitting and standing from different angles (10-15 minutes).

• The images and videos will be uploaded securely to a cloud-based system for analysis.

Part 2: Biomechanics Evaluation and Shoe Testing (Optional, 12 Weeks)

(Only a subset of 50 participants will take part in this phase.)

• One on site visit to Stony Brook University for a biomechanical evaluation of your feet. During this visit you will be given a pair of IAMBIC sneakers to wear for the duration of part 2.

The biomechanical evaluation will consist of:

• 3D Foot Scan: A high-accuracy 3D scanner will be used to capture detailed foot measurements. Device used will be the Artec Space Spider.

• A 3D scan of the feet using a handheld imaging, non-ionizing, visible light-based scanner (Artec ® Space Spider). You will be required to sit and stand in a comfortable position while an IAMBIC technical person will scan your feet

• Plantar Pressure Measurement: You will walk in a straight path while wearing pressure-sensing insoles to measure foot mechanics. The device used will be the Moticon OpenGo.

• An IAMBICtechnical person will replace the insoles in your personal favorite sneaker and your custom-fit personalized IAMBIC sneaker pairs, with the sensor-based insoles. You will then be required to walk in 5 loops at your normal and 1 loop at your fast walking pace at the IAMBIC site. Foot pressure and balance on the bottom will be automatically recorded and transmitted to the secure app via Bluetooth connection.

• Week 1-2:

• You will wear the IAMBIC shoes 5 days a week for between 20 and 30 minutes each day.

• You will fill out virtual questionnaires after each wearing session (5 times per week) to provide feedback on the fit and comfort of the shoes (5-10 mins).

• Week 3-12:
  
  

• You will be required to wear the shoes for at least one session per week and for at least 1 hour per session.

• You will complete one survey a week about the fit and comfort of the shoes (5-10 mins).

• End of Study (Final in-person visit):

• Plantar Pressure Measurement: You will walk in a straight path while wearing pressure-sensing insoles to measure foot mechanics. The device used will be the Moticon OpenGo (45 minutes-1 hour).

• You will leave the IAMBIC custom footwear with the study team for evaluation. Please bring an extra pair of your shoes to wear back from the study.

• You will complete a final comprehensive survey about your overall experience with the shoe fit and comfort of the shoes, and provide feedback for the future improvements. (10-15 mins).

Total Time Commitment

• Part 1: One-time, 15-25 minutes in total.

• Part 2 (Optional): 12 weeks total, with one on-site visit (45-60 minutes) and weekly virtual check-ins. Weeks 1-2 will take between 100-150 minutes per week for walking sessions and 25-50 minutes per week for surveys. Weeks 3-12 will take 1 hour per week for walking sessions and 5-10 minutes per survey. The final in-person visit will take 45 minutes to 1 hour for a biomechanical evaluation and 10-15 minutes to complete a final survey. This will be the end of Part 2 and the entire study for you.  A total of 20.6 hours maximum will be spent on part 2 over 12 weeks.

There are no clinical procedures involved in this study, and no medications or blood samples will be collected.

We will choose people for Part 2 out of the 500 participants from Part 1 to fulfill the following criteria for the group of 50 people:

• Equal parts men and women 

• Range of ages from 18-75

• Range of ethnicities

• Range of foot issues/pain points

There will be photos and videos taken of both your feet, but only for scanning purposes. Personal identifying features like your face, voice, or other defining features will not be included in the photos or videos. Only your foot and ankle will be included. These photos and videos will not be accessible to anyone outside of the research team and will be secured and de-identified to protect your privacy.

RISKS / DISCOMFORTS

The following risks/discomforts may occur as a result of you being in this study:

Part 1

• Disclosure of private information with foot images or videos through an unauthorized data breach or criminal activity (e.g., hacking).

• Feeling uncomfortable while answering questions about foot issues or abnormalities.

Part 2

• Tripping on an obstacle while walking barefoot or in the IAMBIC provided shoes may cause unknown discomfort or injury.

• Disclosure of private information with foot images or videos through an unauthorized data breach or criminal activity (e.g., hacking).

For the duration of the study, all communication between the research team and participants will be done via email. All email communications from the research team will be sent from the email BoneEngineering@stonybrook.edu. The only people with access to this email are PI and research personnel who are authorized users and directly related to the study.

BENEFITS 

There is no direct benefit expected as a result of you being in this study.

However, possible benefits in the future to you and others include a footwear fitting virtual system where consumers scan their feet and are fitted with a custom shoe. The custom shoes provided to part 2 participants for the 12-week period are not included as compensation in this study and will need to be returned to the study team for analysis when Part 2 ends.

PAYMENT TO YOU

You will receive a 15 dollar gift card for your participation in Part 1 of the study at the end and completion of your session. No further compensation will be given after the end of Part 2.

PAYMENT TO THE INSTITUTION 

This project is funded in part, by a contract from IAMBIC INC to the Research Foundation of Stony Brook University, in support of the Investigators' work on this study. The amount of payment from this sponsor is dependent upon approval and continuation of the IRB.

NOTICE OF INVESTIGATOR FINANCIAL CONFLICT OF INTEREST 

The Principal Investigator, Dr. Yi-Xian Qin, has no financial conflict of interest.

INVESTIGATOR’S PERSONAL INTEREST IN THIS STUDY 

The Principal Investigator, Dr. Yi-Xian Qin is interested in the use of AI technology to study and resolve musculoskeletal issues in humans. Dr. Qin has decades of biomedical research in the field of bone engineering and musculoskeletal diseases.

CONFIDENTIALITY  

We will take steps to help make sure that all the information we get about you is kept confidential. Your name will not be used wherever possible. We will use a code instead. All the study data that we get from you will be kept locked up. The code will be locked up too. If any papers and talks are given about this research, your name will not be used.

The videos, and photos taken of you in part 1 will not be deleted and will be shared with IAMBIC after the end of the study, as part of their machine learning model database. IAMBIC will remain in possession of the data even after the study ends. The videos and photos will be stored in a secure cloud which belongs to IAMBIC. Your identity will be protected by not associating your name to any videos or photos. Instead, any data collected from you will be associated with a unique 6-character identifier for data confidentiality. The 6-character identifier will be in the format “WAXXXX”, where WA is followed by a 4-digit number (e.g. WA2001, WA2002, etc.)

The photos and videos taken of your feet will only be used for the machine learning database. After the data is extracted from the images and videos they will be stored in a secure cloud owned by IAMBIC. They will not be deleted.

Your private information will not be shared outside Stony Brook University and IAMBIC. De-identified information will be shared with individuals and organizations that conduct or oversee this research.

We may publish the results of this research. However, we will keep your name and other identifying information confidential.

We protect your information from disclosure to others to the extent required by law. We cannot promise complete secrecy.

Data collected in this research might be deidentified and used for future research or distributed to another investigator for future research without your consent.

We want to make sure that this study is being done correctly and that your rights and welfare are being protected. For this reason, we will share the data we get from you in this study with the study team, the sponsor of the study (and those who work for them), Stony Brook University's Institutional Review Board, applicable Institutional officials, and certain federal offices, including the Office for Human Research Protections (OHRP), and, where applicable, the Food and Drug Administration (FDA). 

Data Management and Sharing

This study is collecting data from you. We would like to make your data available for other research studies performed that may be done in the future by the sponsor or other researchers. The research may be about similar conditions to this study. However, research could also be about unrelated diseases, conditions, or other types of research. These studies may be done by researchers at this institution or other institutions, including commercial entities. Our goal is to make more research possible. We plan to keep your data for 5 years. We do not plan to use your data for anything outside the scope of this research study and/or protocol.

Your data may be shared with researchers around the world. However, the decision to share your data is controlled by Stony Brook University and the sponsor. To get your data, future researchers must seek approval from Stony Brook University and the sponsor. The researchers must agree not to try to identify you. 

Your name and identifying information will be removed from any data you provide before they are shared with other researchers. Researchers cannot easily link your identifying information to the data and biospecimens.

If you no longer wish to have us store or share your data, you should contact yi-xian.qin@stonybrook.edu. We will do our best to honor your request and to retrieve any data that has been shared with other researchers. However, there may be times we cannot. For example, if we do not have a way to identify your data we will not be able to retrieve them. 

In addition, if the data has already been used for research, the information from that research may still be used. We will delete the virtual copies and destroy the physical copies of the data we have or are able to retrieve based on your request.

NOTE: However, if you tell us you are going to hurt yourself, hurt someone else, or if we believe the safety of a child is at risk, we will have to report this. 

In a lawsuit, a judge can make us give them the information we collected about you. 

We will protect your data by only associating it to a 6-character identifier. The 6-character identifier will be in the format “WAXXXX”, where WA is followed by a 4-digit number (e.g. WA2001, WA2002, etc.). Any data collected from you will not be associated with your name. All data will be stored in a secure cloud which is owned by IAMBIC.

This authorization for use and reporting of your health data will remain in effect unless and until you tell us otherwise. You have the right to stop allowing us to use or give out your data. You can do this at any time by writing to Dr. Yi-Xian Qin (Room 215

Bioengineering Bldg, Stony Brook, NY 11794-5281 . If you do this, we will stop collecting any new data from you. We will use any data we collected before you wrote your letter. When you sign the consent form at the end, it means: 

• That you have read this section. 

• That you will allow the use and reporting of your health data as described above. 

COSTS TO YOU  

There are no foreseeable monetary costs associated with participating in this study.

ALTERNATIVES 

Your alternative to being in this study is to simply not participate.

IN CASE OF INJURY 

If you are injured as a result of being in this study, please contact Dr. Yi-Xian Qin at telephone # 631-632-1481. The services of Stony Brook University Hospital will be open to you in case of such injury.

The research procedures contain minimal to no safety risk. However, if you are injured, directly or indirectly, when conducting research tasks, seek immediate medical treatment. Your insurance may be billed for this treatment, but no compensation will be routinely available from the study or sponsor. 

If you are injured as a result of being in this study you do not give up your right to pursue a claim through the legal system.

No additional financial compensation will be made available. 

CONSEQUENCES OF WITHDRAWING 

There are no consequences for choosing to withdraw from this study. If you would like to be withdrawn, please reach out to Dr. Qin and we will delete your data.

Note: If you choose to withdraw from the study after your images have already been used to train an analytical model, the following will occur:

• All raw data, including your images and survey responses, will be deleted.
  
  

• However, any insights or findings that have already been generated using your data will not be removed.
  
  

Please note that any data which cannot be deleted will be fully anonymized and will not be identifiable or traceable back to you in any way.

INFORMATION ABOUT DATA AND/OR SPECIMENS 

Identifiers might be removed from your identifiable private and after such removal, the information  may be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you or your legally authorized representative.

COMMERCIAL DEVELOPMENT 

Your data may be used for commercial profit and you will not share in any commercial profit.

REMOVAL FROM STUDY

The person in charge of this research can remove you from this research without your approval. Possible reasons for removal include:

• It is in your best interest.

• You have developed a foot pathology or have foot/leg trauma that prevents you from fulfilling the research tasks.

• The research is canceled by the funding agency or sponsor.

• You ask to be removed or refuse to comply with instructions related to this study.

Part 2 Specific:

• A participant misses more than 1 session per week for the first two weeks.

• A participant misses more than 2 weeks which are consecutive during weeks 3-10. If a participant must miss more than one session during weeks 3-10, the sessions must not be consecutive and the study team MUST be notified as soon as possible.

We will inform you of any new information that may affect your choice to stay in this research.

COMMERCIAL DEVELOPMENT 

Your data may be used for research and development that is indirectly used for commercial profit and you will not share in any commercial profit.

SUBJECT RESPONSIBILITIES

If you choose to participate and meet the study requirements to enroll in this study, you will have the following responsibilities: 

• Not sharing both your identifier AND name together with anyone other than the PI or study team member.

• Complete study visits

• Complete related questionnaires 

• Report any adverse events such as pain, reaction to the study procedures, hospitalizations, or ER visits.

• (Part 2 only) Complete a session including the survey without interruption. i.e., when performing the tasks at different points of the day (morning, afternoon, evening), complete both the study and follow up survey without considerable interruption. A delay of a few minutes (e.g. 5 minutes) for a personal matter will not be considered an interruption.

• (Part 2 only) You agree to come to the study site, located in the Bioengineering Building, Stony Brook, NY 11794-5200 USA, to take part in the biomechanics evaluation. The first evaluation will consist of 2 sections: 

• A 3D scan of the feet using a handheld imaging, non-ionizing, visible light-based scanner (Artec ® Space Spider). You will be required to sit and stand in a comfortable position while an IAMBIC technical person will scan your feet. 

• Foot plantar pressure measurement using wireless sensor-based insoles (Moticon ® OpenGo). An IAMBIC technical person will replace the insoles in your personal favorite sneaker and your made-to-fit personalized IAMBIC sneaker pairs, with the sensor-based insoles. You will then be required to walk in 5 loops at your normal and 1 loop at your fast walking pace at the IAMBIC site. Foot pressure and balance on the bottom will be automatically recorded and transmitted to the secure app via Bluetooth connection.

The second, and final in-person visit will consist of 2 sections:

• Plantar Pressure Measurement: You will walk in a straight path while wearing pressure-sensing insoles to measure foot mechanics. The device used will be the Moticon OpenGo (45 minutes-1 hour).

• You will complete a final comprehensive survey about your overall experience with the shoe fit and comfort of the shoes, and provide feedback for the future improvements. (10-15 mins).

• Bring back the pair of IAMBIC shoes to wear during the final in-person session of part 2 and return the shoes to the research team for evaluation.

• You will bring a secondary pair of shoes to wear as you leave the study, after returning the research study shoes.

• Make an effort to the best of your ability to follow instructions and provide accurate data.

• Inform the IAMBIC of any difficulties you face when using the app. You can communicate through the app feedback feature or an email to the study coordinator.

RIGHTS AS A RESEARCH SUBJECT  

• Your participation in this study is voluntary. You do not have to be in this study if you don't want to be.

• You have the right to change your mind and leave the study at any time without giving any reason, and without penalty.

• Any new information that may make you change your mind about being in this study will be given to you.

• You can request a digitally signed and dated copy of this consent form to keep.

• You do not lose any of your legal rights by signing this consent form.

QUESTIONS ABOUT THE STUDY AND YOUR RIGHTS AS A RESEARCH SUBJECT   

• If you have any questions, concerns, or complaints about the study, you may contact Dr. Yi-Xian Qin, at telephone # 631-632-1481 or by email at BoneEngineering@stonybrook.edu

• If you have any questions about your rights as a research subject or if you would like to obtain information or offer input, you may contact the Stony Brook University Research Subject Advocate, Ms. Lu-Ann Kozlowski, BSN, RN, (631) 632-9036, OR by email, lu-ann.kozlowski@stonybrook.edu

• Visit Stony Brook University’s Community Outreach page, https://www.stonybrook.edu/commcms/research-community-outreach/index.php

• For more information about participating in research, frequently asked questions, and an opportunity to provide feedback, comments, or ask questions related to your experience as a research subject.

If you check the box below, it means that you have read (or have had read to you) the information given in this consent form, and you would like to be a volunteer in this study.

Please mark the checkbox below to certify that you have read and understand the consent agreement and that you agree to take part in this study:

☐   I have read and understand the consent form and I agree to participate in this study.