Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05287646

Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray

Led by VA Office of Research and Development · Updated on 2026-04-22

21

Participants Needed

1

Research Sites

168 weeks

Total Duration

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Sponsors

V

VA Office of Research and Development

Lead Sponsor

R

Rutgers University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Different prosthetic suspension systems have been developed to decrease this motion, including elevated vacuum suspension, which utilizes a pump to draw air from the socket. However, scientific analyses to understand the movement between the limb and socket have yet to be performed with a high level of accuracy. This study will use a state-of-the art imaging technique, known as dynamic stereo x-ray, to quantify the 3D movement of the residual limb in the socket. It is hypothesized that dynamic stereo x-ray will be a sensitive method to measure differences in residual limb movement between 2 different socket suspension techniques: suction and elevated vacuum suspension. This information is critical for advancing prosthetic treatments to reduce secondary conditions and degenerative changes that result from poor prosthetic fit.

CONDITIONS

Official Title

Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Unilateral transtibial amputation (any cause)
  • At least 18 years old
  • At least 6 months since amputation
  • Current prosthetic user for at least 6 hours per day
Not Eligible

You will not qualify if you...

  • Unable to walk on a treadmill at low to moderate speed
  • Unable to tolerate the socket suspensions
  • Residual limb too short for socket fitting, imaging, or marker placement
  • Mental impairment affecting study compliance
  • Skin problems like burns or poor coverage, or severe contractures preventing prosthetic use
  • Severe neuropathy, uncontrolled diabetes, insensate foot, severe phantom pain, or history of skin ulcers
  • Any other serious medical condition interfering with the study
  • Severe circulatory issues including peripheral vascular disease or pitting edema
  • Cognitive or mental health issues limiting participation
  • Women who are pregnant or plan to become pregnant during the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

VA NY Harbor Healthcare System, New York, NY

New York, New York, United States, 10010-5011

Actively Recruiting

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Research Team

J

Jason Maikos, PhD

CONTACT

M

Michael J Hyre, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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