Each year, around 1500 Veterans join the 623,000 Americans who live with a lower limb amputation. Many of these Veterans choose the arduous path of rehabilitation to remain ambulatory, a process that includes the prescription of a lower limb prosthesis. Much relies on the goodness of fit of their prosthesis. A good fit feels comfortable and enables a variety of ambulatory activities. A poor fit results in discomfort, often accompanied by chronic skin issues, and activities of daily living are curtailed. Conventional prosthetic sockets are custom-built by a skilled prosthetist, carefully formed to fit the Veteran's residual limb, and good fits can usually be obtained. These sockets are rigid, fixed shape structures with the robustness of a bulldozer, built for sustained, heavy-duty action. Unfortunately, the shape of an individual's residual limb can change over time, such that a good fit eventually becomes poor. One estimate suggests a new below-knee socket is needed every three and a half years. The expense of replacing sockets that no longer fit is not insignificant. Medicare expenditures for replacement of existing below-knee sockets and associated components were estimated at $50M in 2017. Importantly, Medicare is estimated to be only 20% of the market, suggesting the estimated expenditure for the entire population with lower limb amputations is likely to be meaningfully larger. A good fitting prosthesis that maintains its fit over time would serve Veterans well. A potential solution that could make a good fit last longer is an adjustable prosthetic socket. While little evidence is available to support prescription practice, the Centers for Medicare and Medicaid Services (CMS) recently authorized reimbursement for adjustable prosthetic sockets, suggesting a compelling need for such a product. To investigate the potential for deleterious effects and how Veterans might use adjustable prosthetic sockets, the aim of this research is to determine the pressure applied to the residual limb by an adjustable prosthetic socket during activities of varying intensity and the activities that induce adjustments. A laboratory-based human subject experiment will be conducted using a custom sensor placed inside the adjustable panel of a study-provided adjustable prosthetic socket. Participants will acclimate to the adjustable prosthetic socket for two weeks in the field, then return to the laboratory to perform seven activities. The pressure inside the prosthesis will be measured during these activities. Participants will also report how tight their socket feels after each activity.
Age range
18 Years – 70 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Distal end pressure while seated (5 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
Distal end pressure while standing (1 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
Distal end pressure while walking at self-selected speed (1 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking up 10% slope at self-selected speed (1 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking down 10% slope at self-selected speed (1 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking 15% faster than self-selected speed (1 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking at self-selected speed (10 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while seated (5 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while standing (1 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking at self-selected speed (1 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking up 10% slope at self-selected speed (1 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking down 10% slope at self-selected speed (1 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking 15% faster than self-selected speed (1 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking at self-selected speed (10 min bout)
Timeframe: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.