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
N/A
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
Researchers are studying how different stiffness levels of prosthetic feet affect people with unilateral transtibial amputation who use either a bone-anchored limb or a standard socket prosthesis. The trial aims to understand how foot stiffness impacts bone-implant loading, function, pain, biomechanics, sensitivity, balance, and fall risk. It also seeks to identify the best foot stiffness to optimize joint loading and reduce energy use during daily activities. Participants will test three types of prosthetic feet: their usual prescribed foot, a foot two stiffness categories softer, and a foot two stiffness categories stiffer, while completing activities of daily living. The study uses a cross-over design with two groups—those with bone-anchored limbs and those with socket prostheses—to compare effects across different foot stiffnesses. Each participant will attend three laboratory visits over about 6 to 8 weeks, each lasting around 4 hours. During these visits, they will undergo motion capture, physical function tests, sensory assessments, and various biomechanical and balance measurements. Researchers will monitor bone-implant stress, gait speed, postural control, and other outcomes to evaluate the impact of prosthetic foot stiffness on daily function and safety.
CONDITIONS
Brief 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
- More than 12 months since bone-anchored limb implantation surgery (Bone Anchored Limb group)
- More than 12 months since limb amputation (Socket Control group)
- Non-vascular amputation cause
- Uses a low profile prosthetic foot (nominal)
- Can walk unassisted for at least 5 minutes
- 18 years of age or older
You will not qualify if you...
- Major amputation on the opposite limb
- Vascular cause of amputation
- Neurologic conditions affecting coordination or balance
- Regular use of assistive devices for community walking
- Inflammatory diseases or diabetes
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 8 weeks
Participants use three different prosthetic foot stiffness conditions in a randomized cross-over design: their currently prescribed foot, a foot two stiffness categories softer, and a foot two stiffness categories stiffer. They complete motion capture collections, physical function tests, and sensory tests under each condition.
3 laboratory visits, each lasting approximately 4 hours
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
N
Natalie Harpenau, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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