Junior LP Foot - Clinical Investigation Protocol

Exploratory Testing of a Pediatric Foot

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.

Study Overview

• Status: Completed
• Conditions: Amputation
• Intervention / Treatment: Device: Prosthetic Foot

Detailed Description

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
• Enrollment (Actual): 13

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prosthetic Foot - Stiffness Testing; Test prosthetic feet with different stiffness properties.

Device: Prosthetic Foot; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Prosthetic Foot Stiffness	User perception of provided prosthetic foot stiffness. Too soft good Too stiff	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Prosthetic Foot Performance	User perception of provided prosthetic foot performance.	2 hours

Collaborators and Investigators

• Sponsor: Össur Iceland ehf
• Collaborators: Shriners Hospitals for Children

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Prosthetic Device
• Other Study ID Numbers: CIP2023101939

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO