K-Socket-Harness for Amputees
(KSH Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRory A Cooper, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Rory A Cooper, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility Criteria

This trial is for Veterans with a single below-elbow amputation who have used any prosthetic arm for at least one year, or five years for early phases. They must have a residual limb of at least 4 inches long but short enough to allow 1.5 inches clearance from a fitted wrist device.

Inclusion Criteria

My residual limb is at least 4 inches long.

I have used a prosthetic for at least 5 years.

I have used a prosthetic for at least 1 year.

See 3 more

Exclusion Criteria

My residual limb is shorter than 4 inches.

I don't have open wounds or conditions that stop me from wearing a prosthetic.

My residual limb allows for more than 1.5 inches clearance from a fitted wrist.

Treatment Details

Interventions

K-Socket-Harness (Procedure)

Trial OverviewThe study tests the K-Socket-Harness (KSH) system, which uses advanced shoe technology for better fit and function in prosthetic arms. It involves design collaboration with Veterans, digital fitting tools, and evaluation through tasks assessing comfort and functionality.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Verify performance gains for the innovative KSH system that can be delivered to Veterans. The new deExperimental Treatment1 Intervention

The investigators will perform several functional tests of the both the KSH system and the standard of care prosthesis: tensile static load bearing capacity before failure, test rowing ergometer 10-minute test before failure measured using strokes per minute, power in Watts, distance in meters, maximal force, and time before failure, range of motion in flexion/extension, and donning/doffing time.

Group II: Verify functionality of the KSH system through testing with end-users.Experimental Treatment1 Intervention

The investigators will use System Usability Scale (SUS) to assess high usability with setup and operation of the device. The investigators will assess Comfort Scores (SCS), evaluate weight and correlate it with user satisfaction. The investigators will report selection outcome between new design and current design. The investigators will asses 1) functional status, (2) health- related quality of life, and (3) satisfaction with services and (4) device scores through the Orthotics and Prosthetics User Survey (OPUS).