Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray
1 other identifier
interventional
21
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2022
CompletedFirst Posted
Study publicly available on registry
March 18, 2022
CompletedStudy Start
First participant enrolled
January 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
April 22, 2026
April 1, 2026
3.2 years
March 9, 2022
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in dynamic residual tibia kinematics between suspension techniques
To evaluate the 6 degree of freedom kinematics of the residual limb within the socket, participants with transtibial amputation will walk on a treadmill at a self-selected speed, at a speed 10% faster than their self-selected speed, and also perform a step-down task from an 18 cm high platform. These movement tasks will be completed under 2 conditions: with the elevated suspension active and with the elevated system inactive (traditional suction). Up to 4 trials of dynamic stereo x-ray will be conducted for each task for each socket condition. For each task, dynamic stereo x-ray data will be collected and analyzed to determine underlying bone movement with respect to the socket. Six degree of freedom residual tibia rotations and translations relative to the prosthetic socket will be measured.
4 weeks post socket fit
Changes in dynamic skin deformation of the residual limb between suspension techniques
Radio-opaque markers will be placed on the residual limb in specific patterns. Participants will walk on a treadmill at a self-selected speed, at a speed 10% faster than their self-selected speed, and also perform a step-down task from an 18 cm high platform. These movement tasks will be completed under 2 conditions: with the elevated suspension active and with the elevated system inactive (traditional suction). Up to 4 trials of dynamic stereo x-ray will be conducted for each task for each socket condition. For each task, dynamic stereo x-ray data will be collected and analyzed to determine underlying skin deformation. The radio-opaque markers on the skin will be tracked during the dynamic trials, and their trajectories in the socket coordinate system will define the motion of the skin relative to the socket. Shear, defined as the change in angle between the markers, and compression, defined as the change in distance between markers and a neutral position, will be calculated.
4 weeks post socket fit
Study Arms (2)
Suction Suspension First
ACTIVE COMPARATORThe residual limb will be imaged during dynamic activities while participants use suction suspension first, then while participants use elevated vacuum suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting.
Elevated Vacuum Suspension First
ACTIVE COMPARATORThe residual limb will be imaged during dynamic activities while participants use elevated vacuum suspension first, then while participants use suction suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting.
Interventions
Participants will be fit with a socket capable of being suspended by both traditional suction and elevated vacuum. Participants will be assessed first with the elevated vacuum system inactive (traditional suction). Residual limb kinematics and skin deformation during movement tasks will be evaluated utilizing dynamic stereo x-ray. The evaluation will then be repeated with the elevated vacuum system active.
Participants will be fit with a socket capable of being suspended by both traditional suction and elevated vacuum. Participants will be assessed first with the elevated vacuum system active. Residual limb kinematics and skin deformation during movement tasks will be evaluated utilizing dynamic stereo x-ray. The evaluation will then be repeated with the elevated vacuum system inactive.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- Rutgers Universitycollaborator
- University of Rhode Islandcollaborator
Study Sites (1)
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011, United States
Related Publications (1)
Paglia DN, Chomack JM, Herlihy DV, Wetterstrand C, Kadkoy Y, Duchnycz R, Kelly P, O'Connor JP, D'Andrea SE, Maikos JT. Mitigation of image distortion during mechanical testing within a dynamic stereo x-ray system. Front Bioeng Biotechnol. 2025 May 19;13:1571639. doi: 10.3389/fbioe.2025.1571639. eCollection 2025.
PMID: 40458257DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Maikos, PhD
VA NY Harbor Healthcare System, New York, NY
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The statistician will be masked to the intervention order.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2022
First Posted
March 18, 2022
Study Start
January 5, 2024
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After study completion
De-identified individual participant data will be stored in a curated data repository that makes the data underlying scientific publications discoverable, freely usable, and citable, while promoting openly available research integrated with scholarly literature.