The purpose of the following study is of exploratory nature to provide design input for a prosthetic foot under development for children with lower limb loss, amputation or deficiency.
Who can participate
Age range
5 Years – 21 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:
* Cognitive ability to understand all instructions and questionnaires in the study (adapted to kids).
* Active prosthesis user
* Transtibial or transfemoral amputation, limb loss or similar level congenital limb deficiency.
* Age 5 or older.
o Age 5-12 years preferred.
* 15 kg \< Body weight \< 55 kg
* 16 ≤ Foot size ≤ 24
* Clearance: Size 16 \> 50mm, Sizes 17-19 \> 60mm, Sizes 20-24 \> 70mm
* Willing and able to participate in the study and follow the protocol, including consent to participate from legal guardian if under 16 years old.
Exclusion Criteria:
* Users with severe residual limb pain or socket problems, which have negative impact on testing and outcome.
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.