Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray
Recruiting now · Not applicable
Conditions studied: Amputation, Lower Limb
In brief
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.
Key facts
- Study ID
- NCT05287646
- Run by
- VA Office of Research and Development
- People needed
- 21
- Starts
- 2024-01-05
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Unilateral transtibial amputation (any etiology)
- At least 18 years old
- At least 6-months post-amputation
- Current prosthetic users (at least 6 hours/day)
You may not qualify if…
- Unable to ambulate on a treadmill at low to moderate speed
- Inability to tolerate the socket suspensions
- Length of the residual limb prohibits socket fitting, dynamic stereo x-ray data capture, or marker placement
- Mental impairment that impedes study compliance
- Skin conditions (i.e. burns or poor skin coverage) as well as those with severe contractures that prevent prior prosthetic wear
- Severe neuropathy, uncontrolled diabetes, have insensate foot, severe phantom pain, or a significant history of skin ulcers
- Any other significant comorbidity that would interfere with the study
- Severe circulatory problems including peripheral vascular disease and pitting edema
- Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
- Women who are pregnant or who plan to become pregnant during the study
Where it is running
- VA NY Harbor Healthcare System, New York, NY — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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