Junior LP Foot - Clinical Investigation Protocol

NCT06156839 | Completed Results

• 1 other identifier: CIP2023101939
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Amputation

Keywords

Prosthetic Device

Outcome Measures

Primary Outcomes (1)

• Overall Prosthetic Foot Stiffness

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

  2 hours

Secondary Outcomes (1)

• Overall Prosthetic Foot Performance

  2 hours

Study Arms (1)

Prosthetic Foot - Stiffness Testing

EXPERIMENTAL

Test prosthetic feet with different stiffness properties.

Device: Prosthetic Foot

Interventions

Prosthetic Foot DEVICE

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

Prosthetic Foot - Stiffness Testing

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• kg \< Body weight \< 55 kg
• ≤ 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.

You may not qualify if:

• Users with severe residual limb pain or socket problems, which have negative impact on testing and outcome.

Sponsors & Collaborators

• Össur Iceland ehf: lead
• Shriners Hospitals for Children: collaborator

Results Point of Contact

• Title: Volker Nissels
• Organization: Össur Iceland ehf.

vnissels@ossur.com

+49 15111324706

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 5, 2023
• Study Start: January 8, 2024
• Primary Completion: April 15, 2024
• Study Completion: December 10, 2024
• Last Updated: June 16, 2026
• Results First Posted: June 16, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share