Status:
RECRUITING
Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Rutgers University
University of Rhode Island
Conditions:
Amputation, Lower Limb
Eligibility:
All Genders
18+ years
Phase:
NA
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. Piston...
Detailed Description
Individuals with lower extremity amputation (LEA) often experience relative motion between their residual limb and the prosthetic socket, such as vertical translation and axial rotation, which can cau...
Eligibility Criteria
Inclusion
- Unilateral transtibial amputation (any etiology)
- At least 18 years old
- At least 6-months post-amputation
- Current prosthetic users (at least 6 hours/day)
Exclusion
- 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
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05287646
Start Date
January 5 2024
End Date
March 31 2026
Last Update
July 15 2025
Active Locations (1)
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1
VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010-5011