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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Mar 9, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how movement occurs between the residual limb (the part of the leg remaining after amputation) and the prosthetic socket in individuals who have had a transtibial amputation (below the knee). Researchers want to understand how different types of prosthetic suspension systems – specifically suction and elevated vacuum – affect this movement. By using a special imaging technique called dynamic stereo x-ray, they aim to measure the three-dimensional movement of the limb in the socket accurately. This information is important for improving prosthetic designs and ensuring better comfort, stability, and health for users.

To participate in this study, individuals must be at least 18 years old, have had a unilateral transtibial amputation for at least six months, and currently use a prosthetic for at least six hours a day. Participants will undergo imaging tests to capture how their limb moves with different socket types. It's important to note that certain health conditions, such as severe skin issues or mental impairments, may prevent someone from taking part in the study. Overall, this research could help lead to better fitting and functioning prosthetics, making daily life easier for amputees.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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