The Advancement of a New Variable-Compliance Socket and Frame System for Transradial Amputees to Optimize Socket Fit and Upper Limb Function
VA Office of Research and Development
Summary
This research and development will improve upon and investigate the potential validity of an innovative new transradial socket and harness design (the KSH system) that offers an alternative to standard hard sockets and rubber liners with a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The project consists of designing, custom fitting and evaluating the function and comfort of the this new novel system. The study will take place in 3 phases; Phase 1, five experienced Veterans with transradial arm amputations will be recruited to provide guidance and to assist with the design and development. Experienced end-user Veterans and Clinical staff will work together to assist with design, develop the fitting process and working with engineers on the design of a completely digital fitting device for measuring the residual limb and locating bony prominences of the limb to inform the socket design. Phase 2, testing and assessment, the design and process validation will take place with the five Veteran upper transradial arm amputees Phase 3, an additional 20 Veterans with transradial arm amputations will be recruited and fit with the KSH system and undergo a series of evaluative tests. Veterans will perform a series of static and dynamic tasks to evaluate function, comfort and load bearing failure. The primary goal of this study is to improve upon the current preliminary prototype and to test it with a broader population of potential users to help advance the engineering and design, and to learn the potential to fit a range of Veterans with transradial amputations.
Description
Acceptance of prosthetic arms has long been a problem for clinical prosthetics, and recent studies indicate that recent advancements have done little to improve usage. Objections related to the fit and comfort of prosthetic arms remain the main reasons cited for the disuse of the devices, numbering nine of the top ten reasons cited for abandonment in a survey study. By addressing the literal point of pain for these users, the investigators hope to increase use and acceptance, allowing existing devices to have more positive impact on Veterans' lives. The breathability of composite sockets has b…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Unilateral transradial arm amputation * Possession of a functioning and wearable previously fit prosthetic arm of any type * Residual limb length of at least 4 inches from the lateral epicondyle to the distal tip * Residual limb length less than or equal to that allowing a clearance of 1.5 inches from a fitted wrist * Must have at least 5-years of prosthetic use experience (For Phase 1 \& 2) * Must have at least 1-year of prosthetic use experience (For Phase 3 only) Exclusion Criteria: * Current open sores or incisions, Heterotopic ossification (HO), traumatic neuromas…
Interventions
- DeviceK-Socket-Harness
A transradial socket and harness design that offers a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The KSH integrated socket, frame, and wrist, the "variable compliance prosthetic socket with breathable matrix," creates a dynamic and secure attachment with a combination of two lacing systems. The lacing systems lengthen and shorten six flexible hinges at the elbow, maintaining a secure attachment throughout the range of motion and accounting for volume changes in the soft tissue of the elbow that would otherwise restrict range of motion or cause the socket to separate from the residual limb.
Location
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburgh, Pennsylvania