RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-05
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05287646

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unilateral transtibial amputation (any etiology)
  2. * At least 18 years old
  3. * At least 6-months post-amputation
  4. * Current prosthetic users (at least 6 hours/day)
  1. * Unable to ambulate on a treadmill at low to moderate speed
  2. * Inability to tolerate the socket suspensions
  3. * Length of the residual limb prohibits socket fitting, dynamic stereo x-ray data capture, or marker placement
  4. * Mental impairment that impedes study compliance
  5. * Skin conditions (i.e. burns or poor skin coverage) as well as those with severe contractures that prevent prior prosthetic wear
  6. * Severe neuropathy, uncontrolled diabetes, have insensate foot, severe phantom pain, or a significant history of skin ulcers
  7. * Any other significant comorbidity that would interfere with the study
  8. * Severe circulatory problems including peripheral vascular disease and pitting edema
  9. * Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
  10. * Women who are pregnant or who plan to become pregnant during the study

Contacts and Locations

Study Contact

Jason Maikos, PhD
CONTACT
(212) 686-7500
Jason.Maikos@va.gov
Michael J Hyre, MS
CONTACT
(212) 686-7500
michael.hyre@va.gov

Principal Investigator

Jason Maikos, PhD
PRINCIPAL_INVESTIGATOR
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Study Locations (Sites)

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jason Maikos, PhD, PRINCIPAL_INVESTIGATOR, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-05
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-01-05
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Prosthesis Fitting
  • Prosthetic Suspension Systems
  • Dynamic Stereo X-Ray
  • Biplanar Fluoroscopy
  • Transtibial Amputation
  • Pistoning
  • Elevated Vacuum Suspension
  • Suction Suspension
  • Lower Extremity Amputation

Additional Relevant MeSH Terms

  • Amputation, Lower Limb