Actively Recruiting
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Led by University of Colorado, Denver · Updated on 2026-04-21
60
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic foot stiffness categories to complete the following 4 Specific Aims: 1) Determine the influence of prosthetic foot stiffness on dynamic bone-implant loading, 2) Determine how prosthetic foot stiffness influences function, pain, and multi-joint biomechanics outcomes, 3) Establish how prosthetic foot stiffness influences osseoperception and fall risk, and 4) Establish target ranges of optimal foot stiffness based on the sensitivity biomechanical outcomes to variability in foot stiffness.
CONDITIONS
Official Title
Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral transtibial amputation due to traumatic, congenital, or cancer-related causes
- Bone-anchored limb implantation surgery at least 12 months ago (Bone Anchored Limb group)
- Limb amputation at least 12 months ago (Socket Control group)
- Non-vascular cause of amputation
- Use of a low profile prosthetic foot (nominal)
- Ability to walk unassisted for 5 minutes
- Age over 18 years
You will not qualify if you...
- Major amputation on the opposite limb
- Vascular cause of amputation
- Neurologic conditions that affect coordination or balance
- Regular use of assistive devices needed for community walking
- Inflammatory diseases or diabetes
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States, 80045-2559
Actively Recruiting
Research Team
B
Brecca Gaffney, PhD
CONTACT
N
Natalie Harpenau, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here