Junior LP Foot - Clinical Investigation Protocol

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.

User testing is needed to get data points for the stiffness curve of the foot. These datapoints are extrapolated from user testing and reduces the risk to design a too stiff or soft device.

Machine tests cannot replace user feedback. The user´s perception helps to detect performance deficits and address these in early stages of the design.

Walking performance may change if the foot is too stiff or too soft. Some of these changes can be spotted by observation through legal guardians or experienced prosthetists. Product changes may be justified based on the observations made by the child, legal guardian, Certified Prosthetist/Orthotist (CPO) or engineers specializing in foot design.

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.