Improving Prosthetic Arms for Amputee: A Better Fit and More Functionality

NCT05990062 | Recruiting

• 1 other identifier: A4257-R
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation, Surgical

Keywords

function; breathability; comfort; transradial

Outcome Measures

Primary Outcomes (8)

• Static tensile load bearing capacity to reach a 50-pound load on an industrial scale

  We will test tensile static load bearing capacity up to a 50 -pound load or to failure. The Veteran will stand safely on an industrial scale with the arm extended at their side and weight will be added to the distal end of the prosthesis until the goal is met or the prosthesis fails. We will perform the task on both the KSH socket and the standard socket.

  20 minutes

• Elbow range of motion in flexion/extension

  We will measure range of motion (in degrees) in flexion/extension with a standard goniometer. We will perform the task on both the KSH socket and the standard socket.

  30 minutes

• Donning/doffing prosthesis

  We will record the time it takes to donn/doff each prosthesis for both the KSH socket and the standard socket.

  30 minutes

• Power in Watts generated on rowing machine

  We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test before failure, as measured using power in Watts. We will perform the task on both the KSH socket and the standard socket.

  10 minutes

• Strokes per 10-minute period

  We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test before failure, as measured using strokes per minute. We will perform the task on both the KSH socket and the standard socket.

  10 minutes

• Distance rowed in meters

  We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test measuring distance in meters before failure or to time expiration. We will perform the task on both the KSH socket and the standard socket.

  10 minutes

• Maximal force before failure

  We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test measuring maximal force (Newton) before failure. We will perform the task on both the KSH socket and the standard socket.

  10 minutes

• Total time before failure

  We will test tensile loads in a dynamic environment before failure. We will test the performance on a rowing ergometer 10-minute test recording the time (in minutes and seconds) before failure. We will perform the task on both the KSH socket and the standard socket.

  10 minutes

Secondary Outcomes (5)

• Usability of prosthesis using the System Usability Score (SUS) on scale from 0-100

  15 minutes

• Socket Comfort Scores (SCS) on a scale from 0-10

  30 minutes

• Weight of device in pounds

  30 minutes

• Participant preference

  10 minutes

• Orthotics and Prosthetics User Survey (OPUS)

  1 hour

Study Arms (2)

Verify performance gains for the innovative KSH system that can be delivered to Veterans. The new de

EXPERIMENTAL

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.

Device: K-Socket-Harness

Verify functionality of the KSH system through testing with end-users.

EXPERIMENTAL

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).

Device: K-Socket-Harness

Interventions

K-Socket-Harness DEVICE

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.

Also known as: KSH System

Verify functionality of the KSH system through testing with end-users.; Verify performance gains for the innovative KSH system that can be delivered to Veterans. The new de

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Current open sores or incisions, Heterotopic ossification (HO), traumatic neuromas, or any other condition preventing the wearing of a prosthetic socket
• Residual limb length less than 4 inches
• Residual limb length greater than that allowing 1.5 inches clearance from a fitted wrist.
• The investigators will make every effort to recruit Veterans. If its found that it is not possible to recruit enough Veterans, the investigators will perform a non-Veteran amendment to this protocol.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Stumpworx LLC: collaborator

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

Related Publications (6)

• Salminger S, Stino H, Pichler LH, Gstoettner C, Sturma A, Mayer JA, Szivak M, Aszmann OC. Current rates of prosthetic usage in upper-limb amputees - have innovations had an impact on device acceptance? Disabil Rehabil. 2022 Jul;44(14):3708-3713. doi: 10.1080/09638288.2020.1866684. Epub 2020 Dec 30.

  PMID: 33377803 BACKGROUND

• Biddiss E, Chau T. Upper-limb prosthetics: critical factors in device abandonment. Am J Phys Med Rehabil. 2007 Dec;86(12):977-87. doi: 10.1097/PHM.0b013e3181587f6c.

  PMID: 18090439 BACKGROUND

• Hichert M, Vardy AN, Plettenburg D. Fatigue-free operation of most body-powered prostheses not feasible for majority of users with trans-radial deficiency. Prosthet Orthot Int. 2018 Feb;42(1):84-92. doi: 10.1177/0309364617708651. Epub 2017 Jun 16.

  PMID: 28621577 BACKGROUND

• Hanspal RS, Fisher K, Nieveen R. Prosthetic socket fit comfort score. Disabil Rehabil. 2003 Nov 18;25(22):1278-80. doi: 10.1080/09638280310001603983.

  PMID: 14617445 BACKGROUND

• Heinemann AW, Bode RK, O'Reilly C. Development and measurement properties of the Orthotics and Prosthetics Users' Survey (OPUS): a comprehensive set of clinical outcome instruments. Prosthet Orthot Int. 2003 Dec;27(3):191-206. doi: 10.1080/03093640308726682.

  PMID: 14727700 BACKGROUND

• Dillingham TR, Pezzin LE, MacKenzie EJ. Limb amputation and limb deficiency: epidemiology and recent trends in the United States. South Med J. 2002 Aug;95(8):875-83. doi: 10.1097/00007611-200208000-00018.

  PMID: 12190225 BACKGROUND

Study Officials

• Rory A Cooper, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth B Toth, BA

CONTACT

(412) 954-5382; elizabeth.toth2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The protocol consists of three phases with iterative design and development process involving input from Veterans with disabilities at various stages. In addition, 5 certified Prosthetists with at least five years of experience working with Veterans with transradial arm amputations will also be recruited to provide guidance and to assist with the design and development of the K-Socket Harness (KSH).

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 14, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data sharing will begin upon the start of enrolling the first subject (10/1/2024) and end at the completion of the study (9/30/2028).

Locations

US (1)