Junior LP Foot - Clinical Investigation Protocol

Össur Iceland ehf13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Amputation

Interventions

Prosthetic FootDEVICE

Stiffness Testing Procedure: * Potential subjects identified, fitting inclusion/exclusion criteria, by Principle Investigator (PI). * Informed consent obtained from participant if applicable, legal guardian or both. * Subject (legal guardian) signs Informed Consent Form (ICF) * Subject ambulates on their current prescribed foot for observation - Questions administered, by PI or delegated by PI * Subject fitted with investigational device, by PI * Subject ambulates in the investigational device for observation - Questions administered, by PI or delegated by PI * Subject is fitted back to their prescribed prosthesis, by PI

Eligibility

Sex: ALLMin age: 5 YearsMax age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Overall Prosthetic Foot Stiffness

User perception of provided prosthetic foot stiffness. Too soft good Too stiff

Time frame: 2 hours

Secondary Outcomes

Overall Prosthetic Foot Performance

User perception of provided prosthetic foot performance.

Time frame: 2 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.