Junior LP Foot - Clinical Investigation Protocol
NCT06156839 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2026-06-16
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
Interventions
- 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
Sponsors & Collaborators
-
Shriners Hospitals for Children
collaborator OTHER -
Össur Iceland ehf
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 5 Years
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-08
- Primary Completion
- 2024-04-15
- Completion
- 2024-12-10
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